**3. Telemedicine**

Sickness Impact Profile [25] and the Nottingham Health Profile [26]. Generic measures like the SF-36 are most useful for comparing quality of life in people with different diseases and the qualityoflifeinpeoplewhohavenodiseaseswiththequalityoflifeinpeoplewhohaveadisease. Some generic measures, such as the Quality of Well-Being Scale [24], generate a single utility index of overall quality of life. This index usually ranges from 0 to 100 and these values can be used to adjust for years of life by degree of health experience to yield a measure of 'qualityadjusted life years'. Such a measure can be used to assess cost-effectiveness and cost benefits acrossvariousinterventionsandillnesses.Manygenericmeasuresofemotionalstatushavebeen employed in studies which include people with diabetes. These include the Well-Being Questionnaire [27], the Profile of Mood States [28], the Symptom Checklist (SCL-90R) [29], the Mini-Mental Status Exam [30]. Depression in people with diabetes has been studied using the following scales:theBeckDepressionInventory [31] andtheZung Self-RatingDepressionScale [32].Anxietyinpeoplewithdiabeteshasbeenstudiedusingthefollowingscales:theBeckAnxiety Inventory [33], and the Zung Self-Rating Anxiety Scale [34]. Both depression and anxiety in people with diabetes have been studied using the Hospital Anxiety and Depression Scale [35]. Illness-specific quality of life measures can focus on the specific problems posed by an individ‐ ualillness.Forexample,evenawell-designedgenericqualityoflifescalewillnotaddress certain aspects of life with diabetes such as hypoglycaemia, insulin injections, self-monitoring of blood glucose (SMBG), and dietary restrictions, which may be critical to an individual's healthrelated quality of life. Generic measures may not be specific enough to detect effects in some areasoffunctioningamongsomepeoplewithdiabetes.Forexample,genericmeasuresofmental health may not identify fear of complications as an important contributing factor. More and more,researchershaveaddeddisease-specificassessmentstogenericones,toincreasetheability oftheirmeasurestoidentifythefactorsmostrelevanttothehealth-relatedqualityoflifeofpeople with a specific disease. Some [18] have even advocated a 3-level approach for clinical trials, incorporating generic and disease-specific measures and, finally, situation-specific questions thatapplytothespecificcondition(neuropathy,forexample)orinterventionbeinginvestigated.

46 Telemedicine

As shown in literature, individuals with DMT2 are known to have lower health-related quality of life (HRQOL) and more depressive symptomatology than those without diabetes [36-39]. The comorbidity of depression in patients with type 2 diabetes mellitus has been observed in several studies [40, 41]. Anderson [41] summarized 20 cross-sectional reports and found that the odds of depression in the diabetic group was twice that of the nondiabetic comparison group. In a population-based study of adults with and without DMT2, investigators found EQ-5D index scores and visual analogue scores were significantly lower for respondents with DMT2 and those with 3−5 risk factors for DMT2 than for those with 0−2 risk factors [42]. In a longitudinal analysis of EQ-5D data collected in 2004 and 2009 among SHIELD (Study to Help Improve Early Evaluation and management of risk factors Leading to Diabetes) respondents with DMT2, found their health status declined significantly, indicating that burden of disease has a long-term detrimental impact on the QoL of individuals living with DMT2 [43]. The high prevalence of depressive symptoms among people with diabetes can be explained by two scenarios: that depression may occur as a consequence of having diabetes or a risk factor for the onset of DMT2. The first prospective study where this association was suggested emerged from the work of Eaton and collaborators in 1996 [44]. Afterwards, several prospective studies

One of the most promising methods for the management of chronic illness and, in particular, diabetes and its consequences is represented by the use of Information and Communication Technology (ITC) tools [68]. Telemedicine includes timely transmission and remote interpre‐ tation of patient data for follow-up and preventative interventions. The main purpose of this approach is to facilitate a productive interaction between the patient and the health care provider in order to achieve improved treatment results and lower treatment costs. The five components of a sound telemedicine system include:


Telemedicine interventions can be communicated from handheld hardware devices to a remote Web server. Hardware for transmission may include

quality of information than handwritten records, which may be incomplete or inadvertently forgotten at home on appointment days. The clinical impact is a more frequent communication of information and instructions, which can lead to improved outcomes with lower A1C levels or fewer adverse sequelae. The behavioural impact is more frequent therapy adjustments and reminders, leading to greater patient education and empowerment. The structural impact is usually time-saving for patients who might need to come in to the physician's office for fewer visits; however, the physician workload of reviewing messages and updated data on a regular

Quality of Life in Telemedicine-Based Interventions for Type-2 Diabetes Patients: The TECNOB Project

http://dx.doi.org/10.5772/56009

49

In a recent review and meta-analysis [79], carried out to determine the effects of telemedicine and teleconsultation regarding clinical, behavioural, and care coordination outcomes of diabetes care compared to usual care, twenty-six studies related to home telehealth for diabetes are included. Results show that, overall, home telehealth interventions were found to be effective in improving glycaemic control (HbA1c) for diabetic persons. Patients in telemedicine group are encouraged to self-monitor blood glucose levels as a part of their disease manage‐ ment programme. The home telehealth interventions help to reduce the number of patients who are hospitalized, number of hospitalizations and bed days of care. However, nonuniform outcomes on the effects of DMT control on quality of life are shown. In fact, in literature, QoL in diabetes is measured by a broad range of validated instruments (the World Health Organ‐ ization Quality of Life-Bref, World Health Organization–Diabetes Treatment Satisfaction Questionnaire, SF-12, SF-36, Diabetes Quality of Life, Depression Scale CES-D, Problem Areas in Diabetes Scale, Visual Analog Scale, Zung Self-Rating Depression Scale, Depression Short-CARE, Diabetes Distress Scale and Health-Related Quality of Life). Despite these reported methodological issues, telemedicine interventions in DMT control show an increase in contact between health care provider and patient, health care perceived as more supportive according to patients, more effective communication, increased metabolic data transmission, availability and completeness of data among health carers, and improved communication both with health

A telemedicine program can be judged as successful if it meets four criteria by being (1) sound, (2) effective, (3) cost-effective, and (4) practical [69]. A sound telemedicine technology facili‐ tates accurate collection of data, accurate input of data, verification of data accuracy, and a process to correct incorrect data. A sound technology will include time stamping of input data to avoid back filling, forward filling, or other data manipulation. An effective technology allows for the determination of process outcome measures, clinical outcome measures, and patient satisfaction. First, the effectiveness of automated telemedicine systems can be meas‐ ured to assess the adoption of process outcomes, such as timely foot screenings, retinal evaluations, vaccine administrations, and measurement of laboratory tests. These tests include A1C, glucose, lipids for all patients with diabetes, and other laboratory analyses for selected diabetes patients, including serum creatinine levels in users of metformin, liver tests in users of statins, serum potassium in hypertensive patients on selected blood pressure medications, and serum fructosamine in some patients with hemoglobinopathies. Second, the effectiveness of telemedicine programs can be assessed on the basis of improvements in objective clinical outcomes, such as A1C levels, number of hypoglycaemic events, glycaemic variability

basis may actually increase.

carers and peers [80].


Data may be transmitted in the form of


Data are then incorporated into the patient's electronic medical record, analyzed, flagged if necessary, and responded to by way of automatic or personalized treatment recommendations, which are transmitted into the patient's computer, cell phone, or other handheld device.

Telemedicine is an automated support tool for patients with diabetes to facilitate better decisions by patients and health care providers. Although some of the most widely imple‐ mented applications of telemedicine have been designed to support recording and interpre‐ tation of serial blood glucose measurements by patients with diabetes, systems have been developed to organize a broadest variety of uploaded objective and subjective data of interest to managing diabetes [73], including patient-collected physiological data, such as


A physician can contact the patient either on a scheduled regular response basis if the situation is safe or on an automatic immediate as-needed basis in the event of a high-risk dangerous event [74]. Images of retinal examinations [75] or foot wounds [76] can be transmitted from a general practitioner's office to a specialist consultant at a remote central location.

Telemedicine programs can impact various aspects of patient care, including informational, clinical, behavioural, structural, and economic [77, 78]. The informational impact is a better quality of information than handwritten records, which may be incomplete or inadvertently forgotten at home on appointment days. The clinical impact is a more frequent communication of information and instructions, which can lead to improved outcomes with lower A1C levels or fewer adverse sequelae. The behavioural impact is more frequent therapy adjustments and reminders, leading to greater patient education and empowerment. The structural impact is usually time-saving for patients who might need to come in to the physician's office for fewer visits; however, the physician workload of reviewing messages and updated data on a regular basis may actually increase.

Telemedicine interventions can be communicated from handheld hardware devices to a

**2.** text messages (short message services) over wireless networks to Web interfaces,

Data are then incorporated into the patient's electronic medical record, analyzed, flagged if necessary, and responded to by way of automatic or personalized treatment recommendations, which are transmitted into the patient's computer, cell phone, or other handheld device.

Telemedicine is an automated support tool for patients with diabetes to facilitate better decisions by patients and health care providers. Although some of the most widely imple‐ mented applications of telemedicine have been designed to support recording and interpre‐ tation of serial blood glucose measurements by patients with diabetes, systems have been developed to organize a broadest variety of uploaded objective and subjective data of interest

**6.** pertinent event data, such as emergency room visits, hospitalizations, scheduled oph‐

**7.** images of retinal photos, wounds, or other structures. The pattern of information can be

A physician can contact the patient either on a scheduled regular response basis if the situation is safe or on an automatic immediate as-needed basis in the event of a high-risk dangerous event [74]. Images of retinal examinations [75] or foot wounds [76] can be transmitted from a

Telemedicine programs can impact various aspects of patient care, including informational, clinical, behavioural, structural, and economic [77, 78]. The informational impact is a better

to managing diabetes [73], including patient-collected physiological data, such as

**1.** blood glucose levels, continuous glucose levels, and blood pressure;

**3.** behavioural information, such as dietary intake and exercise patterns;

thalmology visits, vaccines, and missed clinic appointments; and

general practitioner's office to a specialist consultant at a remote central location.

**2.** laboratory data, such as haemoglobin A1c (A1C) or lipid levels;

**5.** subjective symptoms of hypoglycaemia or other complaints;

**4.** medication dosages, allergies, and other history;

analyzed with decision support software.

remote Web server. Hardware for transmission may include

**3.** portable/laptop computers or desk computers [72].

**4.** live streaming audio or video over the internet.

Data may be transmitted in the form of

**3.** email messages over the internet, or

**1.** voice messages over the phone,

**2.** handheld personal digital assistant devices or diaries [71], and

**1.** cell phones [70],

48 Telemedicine

In a recent review and meta-analysis [79], carried out to determine the effects of telemedicine and teleconsultation regarding clinical, behavioural, and care coordination outcomes of diabetes care compared to usual care, twenty-six studies related to home telehealth for diabetes are included. Results show that, overall, home telehealth interventions were found to be effective in improving glycaemic control (HbA1c) for diabetic persons. Patients in telemedicine group are encouraged to self-monitor blood glucose levels as a part of their disease manage‐ ment programme. The home telehealth interventions help to reduce the number of patients who are hospitalized, number of hospitalizations and bed days of care. However, nonuniform outcomes on the effects of DMT control on quality of life are shown. In fact, in literature, QoL in diabetes is measured by a broad range of validated instruments (the World Health Organ‐ ization Quality of Life-Bref, World Health Organization–Diabetes Treatment Satisfaction Questionnaire, SF-12, SF-36, Diabetes Quality of Life, Depression Scale CES-D, Problem Areas in Diabetes Scale, Visual Analog Scale, Zung Self-Rating Depression Scale, Depression Short-CARE, Diabetes Distress Scale and Health-Related Quality of Life). Despite these reported methodological issues, telemedicine interventions in DMT control show an increase in contact between health care provider and patient, health care perceived as more supportive according to patients, more effective communication, increased metabolic data transmission, availability and completeness of data among health carers, and improved communication both with health carers and peers [80].

A telemedicine program can be judged as successful if it meets four criteria by being (1) sound, (2) effective, (3) cost-effective, and (4) practical [69]. A sound telemedicine technology facili‐ tates accurate collection of data, accurate input of data, verification of data accuracy, and a process to correct incorrect data. A sound technology will include time stamping of input data to avoid back filling, forward filling, or other data manipulation. An effective technology allows for the determination of process outcome measures, clinical outcome measures, and patient satisfaction. First, the effectiveness of automated telemedicine systems can be meas‐ ured to assess the adoption of process outcomes, such as timely foot screenings, retinal evaluations, vaccine administrations, and measurement of laboratory tests. These tests include A1C, glucose, lipids for all patients with diabetes, and other laboratory analyses for selected diabetes patients, including serum creatinine levels in users of metformin, liver tests in users of statins, serum potassium in hypertensive patients on selected blood pressure medications, and serum fructosamine in some patients with hemoglobinopathies. Second, the effectiveness of telemedicine programs can be assessed on the basis of improvements in objective clinical outcomes, such as A1C levels, number of hypoglycaemic events, glycaemic variability according to a predefined formula, or emergency room visits for diabetes-related events. Finally, patient satisfaction can also be used to measure the effectiveness of a telemedicine program. User experience can be quantified by using surveys to measure patient satisfaction, classifying patient feedback in response to provider instructions, and determining the amount of system use by patients [81]. A cost-effective telemedicine technology, compared to usual care, will provide benefits for a cost that is either less expensive than current care ('cost-saving intervention') or a cost-per-benefit ratio, which is within a range that society is already willing to pay for other widely used services. This amount is typically in the range of a cost of up to \$50,000 per each quality adjusted life year gained [82]. At last, a practical telemedicine program will overcome technical and structural problems that have hindered the adoption of many new medical programs. Such problems have included (a) a lack of connectivity between stand-alone diabetes telemedicine systems and hospital electronic medical record systems, (b) inadequate decision support software, and (c) inadequate data encryption and security systems to fully ensure patient privacy. Based on these four criteria for a successful telemedicine program, telemedicine has been demonstrated to be substantial, possibly effective, and somewhat practical, but has not been demonstrated to be cost-effective. Research on telemedicine programs that has been published has typically described short-term projects of up to 12 months. Although most studies of telemedicine programs for type 2 diabetes mellitus have demonstrated improved A1C outcomes [83], such programs in type 1 diabetes have not consistently demonstrated improved A1C levels [84]. One on the largest telemedicine studies conducted was the Informatics for Diabetes Education and Telemedicine project [85]. This study compared the outcomes of a combined Web and streaming video telemedicine system against base therapy without a telemedicine system in 1665 Medicare patients. Telemedicine subjects experienced an improvement in glycaemia control, blood pressure levels, and total and low-density lipoprotein cholesterol levels at 1 year of follow-up. The long-term costs and benefits of telemedicine programs are unknown [84]. Cost-effectiveness data are very sparse, however, because there has been very little work in the way of realistic economic modeling or empiric data analysis in the field of diabetes telemedicine [86]. Patients and providers will need to demonstrate continued ongoing compliance and favourable medical and economic results before these programs will be funded on a widespread basis for long-term care. Telemedicine systems are hindered by technical and structural problems that are being corrected gradually and will likely be solved in the near future.

as internet and mobile cell phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only) will be evaluated in a randomized controlled trial (RCT) with a 12- month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated haemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviours and cognitions, psychopatho‐ logical symptoms and weight-related quality of life (The Self-Report Habit Index – SRHI[89], Weight Efficacy Life Style Questionnaire – WELSQ [90], Body Uneasiness Test – BUT [91], Binge Eating Scale – BES [92, 93], Eating Disorder Inventory EDI-2 [94], Symptom Check List - SCL-90 [95], Impact of Weight on Quality of Life-Lite - IWQOL-Lite [96], The Outcome Questionnaire - OQ 45.2 [97]). According to the Consensus Statement on the Worldwide Standardization of the Haemoglobin A1C Measurement [98], the haemoglobin A1C (A1C) assay has become the gold-standard in measurement of chronic glycaemia for over two decades. Anchored in the knowledge that elevated A1C values increase the likelihood of the micro-vascular complications of diabetes (and perhaps macro-vascular complications as well), the assay has become the cornerstone for the assessment of diabetes care. In this study, we adopt the measurement method (concentration of only one molecular species of glycated A1C) and results reporting (mmol/mol and derived NGSP %) developed by the International

Quality of Life in Telemedicine-Based Interventions for Type-2 Diabetes Patients: The TECNOB Project

http://dx.doi.org/10.5772/56009

51

In this paper only weight and disordered eating-related behaviours and cognitions (EDI- 2) data were analyzed and reported. Weight was assessed with the participant in lightweight clothing with shoes removed on a balance beam scale. The EDI-2 is a widely used, standar‐ dized, self-report measure of psychological symptoms commonly associated with anorexia nervosa, bulimia nervosa and other eating disorders. The EDI-2 does not yield a specific diagnosis of eating disorder. It is aimed at the measurement of psychological traits or symptom clusters presumed to have relevance to understanding and treatment of eating disorders. The EDI-2 consists of 11 subscales derived from 91 items. Three of the subscales were designed to assess attitudes and behaviours concerning eating, weight and shape (Drive for Thinness, Bulimia, Body Dissatisfaction) and the remaining eight ones tapped more general constructs or psychological traits clinically relevant to eating disorders (Ineffectiveness, Perfection, Interpersonal Distrust, Interoceptive Awareness, Maturity Fears, Asceticism, Impulse Regu‐

During the in-patient phase, participants attend an intensive four-week hospital-based and medically-managed program for weight reduction and rehabilitation. All patients are placed on a hypocaloric nutritionally balanced diet tailored to the individual after consultation with a dietician (energy intake around 80% of the basal energy expenditure estimated accord‐ ing to the Harris-Benedict equation and a macronutrient composition of 16% proteins, 25% fat and 59% carbohydrates). Furthermore, they receivegeneral well-being. The authors of this measure nutritional counselling provided by a dietician, brief psychological counsel‐ ling provided by a clinical psychologist and physical activity training provided by a physiotherapist. Nutritional rehabilitation program's aim to improve and promote change in eating habits and consists of both individual sessions (dietary assessment, evaluation of

Federation of Clinical Chemistry and Laboratory Medicine (IFCC)

lation and Social Insecurity) [94, 99].

## **4. Technology for obesity project**

In order to determine which features of telemedicine and internet-based interventions are critical in a cost-effective approach, TECNOB project has been developed. TECNOB (TECh‐ Nology for OBesity) Project is a comprehensive two-phase stepped down program enhanced by telemedicine for the medium-term treatment of obese and diabetic people seeking inter‐ vention for weight loss [87, 88]. Its core features are the hospital-based intensive treatment (1 month), that consists of diet therapy, physical training and psychological counselling, and the continuity of care at home using new information and communication technologies (ICT) such as internet and mobile cell phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only) will be evaluated in a randomized controlled trial (RCT) with a 12- month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated haemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviours and cognitions, psychopatho‐ logical symptoms and weight-related quality of life (The Self-Report Habit Index – SRHI[89], Weight Efficacy Life Style Questionnaire – WELSQ [90], Body Uneasiness Test – BUT [91], Binge Eating Scale – BES [92, 93], Eating Disorder Inventory EDI-2 [94], Symptom Check List - SCL-90 [95], Impact of Weight on Quality of Life-Lite - IWQOL-Lite [96], The Outcome Questionnaire - OQ 45.2 [97]). According to the Consensus Statement on the Worldwide Standardization of the Haemoglobin A1C Measurement [98], the haemoglobin A1C (A1C) assay has become the gold-standard in measurement of chronic glycaemia for over two decades. Anchored in the knowledge that elevated A1C values increase the likelihood of the micro-vascular complications of diabetes (and perhaps macro-vascular complications as well), the assay has become the cornerstone for the assessment of diabetes care. In this study, we adopt the measurement method (concentration of only one molecular species of glycated A1C) and results reporting (mmol/mol and derived NGSP %) developed by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)

according to a predefined formula, or emergency room visits for diabetes-related events. Finally, patient satisfaction can also be used to measure the effectiveness of a telemedicine program. User experience can be quantified by using surveys to measure patient satisfaction, classifying patient feedback in response to provider instructions, and determining the amount of system use by patients [81]. A cost-effective telemedicine technology, compared to usual care, will provide benefits for a cost that is either less expensive than current care ('cost-saving intervention') or a cost-per-benefit ratio, which is within a range that society is already willing to pay for other widely used services. This amount is typically in the range of a cost of up to \$50,000 per each quality adjusted life year gained [82]. At last, a practical telemedicine program will overcome technical and structural problems that have hindered the adoption of many new medical programs. Such problems have included (a) a lack of connectivity between stand-alone diabetes telemedicine systems and hospital electronic medical record systems, (b) inadequate decision support software, and (c) inadequate data encryption and security systems to fully ensure patient privacy. Based on these four criteria for a successful telemedicine program, telemedicine has been demonstrated to be substantial, possibly effective, and somewhat practical, but has not been demonstrated to be cost-effective. Research on telemedicine programs that has been published has typically described short-term projects of up to 12 months. Although most studies of telemedicine programs for type 2 diabetes mellitus have demonstrated improved A1C outcomes [83], such programs in type 1 diabetes have not consistently demonstrated improved A1C levels [84]. One on the largest telemedicine studies conducted was the Informatics for Diabetes Education and Telemedicine project [85]. This study compared the outcomes of a combined Web and streaming video telemedicine system against base therapy without a telemedicine system in 1665 Medicare patients. Telemedicine subjects experienced an improvement in glycaemia control, blood pressure levels, and total and low-density lipoprotein cholesterol levels at 1 year of follow-up. The long-term costs and benefits of telemedicine programs are unknown [84]. Cost-effectiveness data are very sparse, however, because there has been very little work in the way of realistic economic modeling or empiric data analysis in the field of diabetes telemedicine [86]. Patients and providers will need to demonstrate continued ongoing compliance and favourable medical and economic results before these programs will be funded on a widespread basis for long-term care. Telemedicine systems are hindered by technical and structural problems that are being corrected gradually

In order to determine which features of telemedicine and internet-based interventions are critical in a cost-effective approach, TECNOB project has been developed. TECNOB (TECh‐ Nology for OBesity) Project is a comprehensive two-phase stepped down program enhanced by telemedicine for the medium-term treatment of obese and diabetic people seeking inter‐ vention for weight loss [87, 88]. Its core features are the hospital-based intensive treatment (1 month), that consists of diet therapy, physical training and psychological counselling, and the continuity of care at home using new information and communication technologies (ICT) such

and will likely be solved in the near future.

50 Telemedicine

**4. Technology for obesity project**

In this paper only weight and disordered eating-related behaviours and cognitions (EDI- 2) data were analyzed and reported. Weight was assessed with the participant in lightweight clothing with shoes removed on a balance beam scale. The EDI-2 is a widely used, standar‐ dized, self-report measure of psychological symptoms commonly associated with anorexia nervosa, bulimia nervosa and other eating disorders. The EDI-2 does not yield a specific diagnosis of eating disorder. It is aimed at the measurement of psychological traits or symptom clusters presumed to have relevance to understanding and treatment of eating disorders. The EDI-2 consists of 11 subscales derived from 91 items. Three of the subscales were designed to assess attitudes and behaviours concerning eating, weight and shape (Drive for Thinness, Bulimia, Body Dissatisfaction) and the remaining eight ones tapped more general constructs or psychological traits clinically relevant to eating disorders (Ineffectiveness, Perfection, Interpersonal Distrust, Interoceptive Awareness, Maturity Fears, Asceticism, Impulse Regu‐ lation and Social Insecurity) [94, 99].

During the in-patient phase, participants attend an intensive four-week hospital-based and medically-managed program for weight reduction and rehabilitation. All patients are placed on a hypocaloric nutritionally balanced diet tailored to the individual after consultation with a dietician (energy intake around 80% of the basal energy expenditure estimated accord‐ ing to the Harris-Benedict equation and a macronutrient composition of 16% proteins, 25% fat and 59% carbohydrates). Furthermore, they receivegeneral well-being. The authors of this measure nutritional counselling provided by a dietician, brief psychological counsel‐ ling provided by a clinical psychologist and physical activity training provided by a physiotherapist. Nutritional rehabilitation program's aim to improve and promote change in eating habits and consists of both individual sessions (dietary assessment, evaluation of

nutrient intake and adequacy, nutritional status, anthropometric, eating patterns, history of being overweight, readiness to adopt change) and group sessions (45 minutes each twice a week) including: information on obesity and related health risks, setting of realistic goals for weight loss, healthy eating in general, general nutrition and core food groups, weight management and behaviour change strategies for preventing relapse). Psychological counselling is provided once a week both individually and in group setting. Individual sessions, lasting 45 minutes each, are mainly based on the cognitive-behavioural approach described by Cooper and Fairburn [100] and emphasize the techniques of self- monitor‐ ing, goal setting, time management, prompting and cueing, problem solving, cognitive restructuring, stress management and relapse prevention. Group sessions (small groups of 5/6 persons), lasting 1 hour each, focus on issues such as motivation to change, assertive‐ ness, self-esteem, self-efficacy and coping. Developing a sense of autonomy and compe‐ tence are the primary purposes of the in-hospital interventions. Patients are afforded the skills and tools for change and are supported in assigning positive values to healthy behaviours and also in aligning them with personal values and lifestyle patterns. Physical activity takes place once a day except for weekends and consists of group programs (20 individuals) based on postural gymnastics, aerobic activity and walks in the open. Pa‐ tients with specific orthopaedic complications carry out individual activities planned by physiotherapists and articulated in programs of physical therapy, assisted passive and active mobilization and isokinetic exercise. In the last week of hospitalization, just before dis‐ charge from the hospital, participants allocated to the TECNOB program are instructed for the outpatient phase. Firstly, they receive a multisensory armband (SenseWear® Pro3 Armband) [101], an electronic tool that enables automated monitoring of total energy expenditure (calories burned), active energy expenditure, physical activity duration and levels (METs). Patients are instructed to wear this device on the back of the upper arm and to record data for 36 hours every two weeks in a free-living context. The Armband holds up to 12 days of continuous data which the outpatients are instructed to download into their personal computer and to transmit online to a web-site specifically designed for data storing. Outpatients are also told that they can review their progress using the Sense‐ Wear® 6.1 Software which analyzes and organizes data into graphs and reports. Second‐ ly, participants are instructed to use the TECNOB webplatform, an interactive web-site developed by TELBIOS S.P.A. (http://www.telbios.it). The TECNOB web-platform sup‐ ports several functions and delivers many utilities, such as questionnaires, an animated food record diary, an agenda and a videoconference virtual room. In the "questionnaires" section, patients submit data concerning weight and glycated hemoglobin. In the "food record diary" participants submit actual food intake day by day through the selection of food images from a comprehensive visual database provided by METEDA S.P.A. (http://www.meteda.it). The same procedure is also possible through a software called METADIETA (Meteda s.p.a.) previously installed on the outpatients' mobile phones before discharge. Through the mobile phones outpatients maintain the contact with the dietitian who regularly sends them SMS containing syntax codes that METADIETA, the software previously installed into the outpatients' mobile phones, used in order to visually display the food choices (frequency and portions) outpatients have to adhere according to dietary prescriptions. In this way,

outpatients can keep a food record diary allowing comparisons between current eating and the recommended hypocaloric diet along the whole duration of the program. The"agen‐ da" allows the patients to remember the videoconference appointments with the clinicians and the days when to fill in the questionnaires. Moreover, the patients can use the "memo" space to note down any important event occurred to him/her in the previous week/ month. The clinical psychologist has thus the opportunity to discuss with the outpatients about the significant events reported in the "memo" space during the videoconference sessions and cognitively reconstruct dysfunctional appraisals in functional ways. Finally, outpatients are instructed to use the videoconference tool. Thanks to this medium, they receive nutritional and cognitive-behavioural telecounselling with the dietitian and the clinical psychologist who attended the patients inside the hospital. In particular, just after discharge, participants have 6 videoconference contacts with both clinicians along 3 months. From the 3rd to the 6th month sessions are scheduled every 30 days and then even more spaced up to an interval of 60 days. During telesessions, clinicians (psychologist and dietitian) test the outpatients' progress, their mood, the maintenance of the"good alimenta‐ ry and physical activity habits", the loss/increase of weight and ask about critical mo‐ ments, especially those ones reported on the "memo"web-space. In particular, telesessions with the clinical psychologist aim to consolidate strategies and abilities acquired during the in-patient phase, to improve self-esteem and self-efficacy, to support motivation, to prevent relapse and to provide problem-solving and crisis counselling. On the other hand, a dietician assesses adherence and compliance to dietary therapy with a special focus on normal eating behaviour, sufficient fluid intake, hunger and fullness regulation, appropriate eating/ etiquette (pace and timing of meals), slow rate of eating, and addresses critical points such as plateau in weight loss or lack of readiness to improve dietary habits. In addition to videoconferences, outpatients can further contact clinicians by e-mail. Indeed, each patient is given the possibility to join his clinician beyond the established videoconference con‐ tacts in case of urgency or emergency. According to the e-message's content, clinicians choose the most appropriate format for delivering feedback among e-mail or telephone. In order to avoid excessive dependence and to contain costs, a maximum number of 1 not scheduled contact a week is established a priority. Great relevance is given to the clinicianspatient relationship as an important medium and vehicle of change. After discharge, outpatients begin to experience the autonomy and competence to change they develop during the in-patient phase and inevitably face resistances and barriers. Thanks to videocon‐ ferences, outpatients are supported by the clinicians who attended them during the inhospital phase in exploring resistances and barriers they experience and in finding functional pathways to cope. Furthermore, outpatients are helped to experience mastery in terms of

Quality of Life in Telemedicine-Based Interventions for Type-2 Diabetes Patients: The TECNOB Project

http://dx.doi.org/10.5772/56009

53

the health behaviour change that needs to be engaged.

Some preliminary results are now available. As indicated in a recent paper [87], at present 72 obese patients with type 2 diabetes have been recruited and randomly allocated to the

**5. Conclusion**

outpatients can keep a food record diary allowing comparisons between current eating and the recommended hypocaloric diet along the whole duration of the program. The"agen‐ da" allows the patients to remember the videoconference appointments with the clinicians and the days when to fill in the questionnaires. Moreover, the patients can use the "memo" space to note down any important event occurred to him/her in the previous week/ month. The clinical psychologist has thus the opportunity to discuss with the outpatients about the significant events reported in the "memo" space during the videoconference sessions and cognitively reconstruct dysfunctional appraisals in functional ways. Finally, outpatients are instructed to use the videoconference tool. Thanks to this medium, they receive nutritional and cognitive-behavioural telecounselling with the dietitian and the clinical psychologist who attended the patients inside the hospital. In particular, just after discharge, participants have 6 videoconference contacts with both clinicians along 3 months. From the 3rd to the 6th month sessions are scheduled every 30 days and then even more spaced up to an interval of 60 days. During telesessions, clinicians (psychologist and dietitian) test the outpatients' progress, their mood, the maintenance of the"good alimenta‐ ry and physical activity habits", the loss/increase of weight and ask about critical mo‐ ments, especially those ones reported on the "memo"web-space. In particular, telesessions with the clinical psychologist aim to consolidate strategies and abilities acquired during the in-patient phase, to improve self-esteem and self-efficacy, to support motivation, to prevent relapse and to provide problem-solving and crisis counselling. On the other hand, a dietician assesses adherence and compliance to dietary therapy with a special focus on normal eating behaviour, sufficient fluid intake, hunger and fullness regulation, appropriate eating/ etiquette (pace and timing of meals), slow rate of eating, and addresses critical points such as plateau in weight loss or lack of readiness to improve dietary habits. In addition to videoconferences, outpatients can further contact clinicians by e-mail. Indeed, each patient is given the possibility to join his clinician beyond the established videoconference con‐ tacts in case of urgency or emergency. According to the e-message's content, clinicians choose the most appropriate format for delivering feedback among e-mail or telephone. In order to avoid excessive dependence and to contain costs, a maximum number of 1 not scheduled contact a week is established a priority. Great relevance is given to the clinicianspatient relationship as an important medium and vehicle of change. After discharge, outpatients begin to experience the autonomy and competence to change they develop during the in-patient phase and inevitably face resistances and barriers. Thanks to videocon‐ ferences, outpatients are supported by the clinicians who attended them during the inhospital phase in exploring resistances and barriers they experience and in finding functional pathways to cope. Furthermore, outpatients are helped to experience mastery in terms of the health behaviour change that needs to be engaged.

#### **5. Conclusion**

nutrient intake and adequacy, nutritional status, anthropometric, eating patterns, history of being overweight, readiness to adopt change) and group sessions (45 minutes each twice a week) including: information on obesity and related health risks, setting of realistic goals for weight loss, healthy eating in general, general nutrition and core food groups, weight management and behaviour change strategies for preventing relapse). Psychological counselling is provided once a week both individually and in group setting. Individual sessions, lasting 45 minutes each, are mainly based on the cognitive-behavioural approach described by Cooper and Fairburn [100] and emphasize the techniques of self- monitor‐ ing, goal setting, time management, prompting and cueing, problem solving, cognitive restructuring, stress management and relapse prevention. Group sessions (small groups of 5/6 persons), lasting 1 hour each, focus on issues such as motivation to change, assertive‐ ness, self-esteem, self-efficacy and coping. Developing a sense of autonomy and compe‐ tence are the primary purposes of the in-hospital interventions. Patients are afforded the skills and tools for change and are supported in assigning positive values to healthy behaviours and also in aligning them with personal values and lifestyle patterns. Physical activity takes place once a day except for weekends and consists of group programs (20 individuals) based on postural gymnastics, aerobic activity and walks in the open. Pa‐ tients with specific orthopaedic complications carry out individual activities planned by physiotherapists and articulated in programs of physical therapy, assisted passive and active mobilization and isokinetic exercise. In the last week of hospitalization, just before dis‐ charge from the hospital, participants allocated to the TECNOB program are instructed for the outpatient phase. Firstly, they receive a multisensory armband (SenseWear® Pro3 Armband) [101], an electronic tool that enables automated monitoring of total energy expenditure (calories burned), active energy expenditure, physical activity duration and levels (METs). Patients are instructed to wear this device on the back of the upper arm and to record data for 36 hours every two weeks in a free-living context. The Armband holds up to 12 days of continuous data which the outpatients are instructed to download into their personal computer and to transmit online to a web-site specifically designed for data storing. Outpatients are also told that they can review their progress using the Sense‐ Wear® 6.1 Software which analyzes and organizes data into graphs and reports. Second‐ ly, participants are instructed to use the TECNOB webplatform, an interactive web-site developed by TELBIOS S.P.A. (http://www.telbios.it). The TECNOB web-platform sup‐ ports several functions and delivers many utilities, such as questionnaires, an animated food record diary, an agenda and a videoconference virtual room. In the "questionnaires" section, patients submit data concerning weight and glycated hemoglobin. In the "food record diary" participants submit actual food intake day by day through the selection of food images from a comprehensive visual database provided by METEDA S.P.A. (http://www.meteda.it). The same procedure is also possible through a software called METADIETA (Meteda s.p.a.) previously installed on the outpatients' mobile phones before discharge. Through the mobile phones outpatients maintain the contact with the dietitian who regularly sends them SMS containing syntax codes that METADIETA, the software previously installed into the outpatients' mobile phones, used in order to visually display the food choices (frequency and portions) outpatients have to adhere according to dietary prescriptions. In this way,

52 Telemedicine

Some preliminary results are now available. As indicated in a recent paper [87], at present 72 obese patients with type 2 diabetes have been recruited and randomly allocated to the TECNOB program (n=37) or to a control condition (n=39). However, only 34 participants have completed at least the 3-month follow-up and have been included in this ad interim analysis. 21 out of them have reached also the 6-month follow-up and 13 have achieved the end of the program. The first ad interim analysis of the data from the TECNOB study has not revealed any significant difference between the TECNOB program and a control condition in weight change at 3, 6 and 12 months. Within-group analysis showed significant reductions of initial weight at all time-points but not at 12-month follow-up. The median percentage of initial weight loss for the whole sample was -5,1 kg (-6,6 to-3,7) at discharge from the hospital. Completers analysis of data collected at 6 and 12 months showed that participants regained back part of the weight loss and the difference between weight at baseline and at 12-month follow-up was no more statistically significant.

**Author details**

seppe, Verbania, Italy

**References**

30(7):28-32.

Jun;15(3):205-18.

2006 Mar;62(5):1153-66.

Oct;24(10):1751-7.

Stefania Corti1,2, Gian Mauro Manzoni1,3, Giada Pietrabissa1,3 and Gianluca Castelnuovo1,3

2 Department of Psychology, University of Bergamo, Italy

www.cdc.gov/nchs/fastats/diabetes.htm.

chronic disease. Lancet. 2008 Jul 19;372(9634):246-55.

to chronic disease. Annu Rev Psychol. 2007;58:565-92.

3 Department of Psychology, Catholic University of Milan, Italy

1 Istituto Auxologico Italiano IRCCS, Psychology Reseach Laboratory, Ospedale San Giu‐

Quality of Life in Telemedicine-Based Interventions for Type-2 Diabetes Patients: The TECNOB Project

http://dx.doi.org/10.5772/56009

55

[1] Organization WH. Diabetes. 2011 [cited Fact sheet N°312 27 August 2012]; Available

[2] Prevention CfDCa. Diabetes. 2012 [cited 2012 28 August 2012]; Available from: http://

[3] Federation ID. The Economic Impacts of Diabetes 2009 [cited 2012 28 August]; Avail‐

[4] Economic costs of diabetes in the U.S. In 2007. Diabetes Care. 2008 Mar;31(3):596-615. [5] Irish C. Home health care: helping to prevent and treat diabetes. Caring. 2011 Jul;

[6] Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999 May-

[7] Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome—a review of quality of life measurement in adults with diabetes. Diabetic Medicine. 2009;26(4):315-27. [8] de Ridder D, Geenen R, Kuijer R, van Middendorp H. Psychological adjustment to

[9] Sharpe L, Curran L. Understanding the process of adjustment to illness. Soc Sci Med.

[10] Stanton AL, Revenson TA, Tennen H. Health psychology: psychological adjustment

[11] Fisher L, Chesla CA, Mullan JT, Skaff MM, Kanter RA. Contributors to depression in Latino and European-American patients with type 2 diabetes. Diabetes Care. 2001

[12] Fisher L, Mullan JT, Arean P, Glasgow RE, Hessler D, Masharani U. Diabetes distress but not clinical depression or depressive symptoms is associated with glycemic con‐

from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html.

able from: http://www.idf.org/diabetesatlas/economic-impacts-diabetes.

Differences in eating-related behaviours and cognitions (EDI-2) were also examined. At baseline, the control group showed higher scores in many EDI-2 scales, i.e. Drive for Thinness, Ineffectiveness, Interoceptive awareness, Impulse regulation and Social Insecurity, compared with the TECNOB group. Notably, these groups included selected participants (those patients that have come through at least the 3-month follow-up) and such statistically significant differences were not found when the original groups were compared. Control group showed higher scores also in Interpersonal distrust at 12 months. However, this result has to be seen with caution because of the few patients (n=12) who have achieved the end of the program at present.

Remarkably, sample sizes at 6 and 12 months are small (n=21 and n=12 respectively) due to the ongoing status of the study and these results may be unreliable. These ad interim findings did not support the effectiveness of the TECNOB protocol over a control condition. Notably, this kind of data analysis (ad interim analysis) is underpowered and results obtained may not be reliable, in particular at 6 and 12 months. However, we gained a significant insight into an important component of the study design, i.e. the hospital-based program. The effect that such uncontrolled factor has on weight loss was very high and probably overwhelmed the effect of the TECNOB intervention. Hence, much statistical power is necessary to enhance the chance to detect the effect of the TECNOB program: the hospital-based program has a very high effect in the first months after discharge but such effect may reduce in the long term. A 12-month follow-up is probably sufficient to detect the TECNOB effect over and above the weakened effect of the hospital base program. Study and information collection is an on-going process and complete results, in particular about glycated haemoglobin and QoL indices, will be published in the next years.
