Telemedicine Home-based Management in Patients With CHF and Type 2 Diabetes

Study Overview
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Brief Summary
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The progressive ageing of the population of industrialized countries is accompanied by a dramatic increase in the prevalence of chronic multi-pathologies. In the general population, HF is associated with a higher prevalence of T2DM compared with patients without HF and with marked regional differences observed in Europe and the rest of the world. In clinical trials of chronic HF patients, the prevalence of T2DM is approximately 30% in patients with reduced or preserved ejection fraction and rises to as much as 45% in hospitalized patient registries. A complex drug regimen is often associated with low adherence in patients with HF and T2DM and poor adherence is associated with adverse clinical events. Similarly, adherence to recommendations regarding lifestyle changes, such as increasing physical activity, is often limited despite these changes' favourable effects on the patient. Therefore, interventions are needed to improve all these factors and optimize adherence. The inclusion of telemedicine (telenursing, telerehabilitation, mHealth) focused on health and correct behaviour can create opportunities to implement customized and scalable solutions in populations at risk. The project will aim to evaluate for patients with chronic diseases with a complex phenotype (heart failure and type II diabetes mellitus) the effectiveness of a remote surveillance program with particular attention to lifestyle changes.

Official Title
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Telemedicine Home-based Management in Patients With Chronic Heart Failure and Type 2 Diabetes: a Randomized Control Study

Conditions
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Chronic Heart Failure, Diabetes Mellitus

Intervention / Treatment
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* Other: Teleassistance
* Other: Teleconsultation
* Other: Telerehabilitation
* Other: Telemonitoring
* Other: mHealth
* Other: telepsycology
* Other: Quality of life
* Other: Biochemistry evaluation
* Other: Clinical evaluation
* Other: State of health of the patient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inform consent Age ≥ 18 years Documented diagnosis of heart failure, NYHA class II-III (reduced or preserved Ejection fraction without hospitalization in the last 3 months Diagnosis of Diabetes Mellitus Type II in pharmacological treatment from at least one month Ability to walk without assistive devices Consent to using a device (independently or with the support of a caregiver) for recording the single electrocardiographic trace at home Consent to using the App Exclusion Criteria: Subjects with poor collaboration No possibility of using mobile technology Life expectancy of fewer than 6 months Medical issues that preclude participation in the program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>At the beginning and at the end of the 6-month study period, patients of the Intervention group will perform outpatient cardiological visits. During the 6-month they will be followed through a home remote teleassistance program, designed to provide multidisciplinary support. | Other: Teleassistance<br>* Support the nursing case manager through a structured teleconsultation program (telephone and videoconference support at least once a week)<br>Other: Teleconsultation<br>* Cardiological and Diabetological teleconsultation at the beginning of the program and in case of need during the program.<br>Other: Telerehabilitation<br>* Support from a physiotherapist (if needed)<br>Other: Telemonitoring<br>* Telemonitoring of patient vital signs (eg single electrocardiographic trace) and delay steps<br>Other: mHealth<br>* The support of an App for recording and monitoring parameters: delay treatment, clinical parameters such as glycemia, blood pressure, HR, symptoms, etc.<br>Other: telepsycology<br>* Psychological support (if necessary)<br>Other: Quality of life<br>* Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire<br>Other: Biochemistry evaluation<br>* Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP<br>Other: Clinical evaluation<br>* 6-minute-walking test, IMC, NYHA class, Ejection fraction<br>Other: State of health of the patient<br>* Severity Index and Comordbidity index<br>|
| Active Comparator: Control group<br>At the beginning and at the end of the 6-month study period, patients of the Control group will perform outpatient cardiological visits. During the 6-month at home, patients will be followed in the usual care model by GP. | Other: Quality of life<br>* Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire<br>Other: Biochemistry evaluation<br>* Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP<br>Other: Clinical evaluation<br>* 6-minute-walking test, IMC, NYHA class, Ejection fraction<br>Other: State of health of the patient<br>* Severity Index and Comordbidity index<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tolerance capacity | The change from baseline in tolerance capacity will be measured by walking test performance (meters walked). | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hospitalizations | Change of hospitalizations for cardiovascular problems, diabetes and all-causes | 6 months | 
| Number of Steps | The difference in the weekly mean in the number of steps from baseline over the 6 months of follow-up. | Baseline and 6 months | 
| HbA1c dosage | Change of the disease status | Baseline and 6 months | 
| Change in quality of life related to heart failure | Change in quality of life measured by Minnesota Living with Heart Failure (MLHFQ) questionnaire | Baseline and 6 months | 
| Change in quality of life related to Diabetes | Change in quality of life measured by Diabetes quality of life (DQoL) questionnaire | Baseline and 6 months | 
| Change in quality of life | Change in quality of life measured by 12-item Short Form Survey (SF-12) questionnaire | Baseline and 6 months | 
| Assessment of physical activity. | Change in physical activity profile by Physical Activity Scale for the Elderly (PASE). The total PASE score is computed by multiplying the amount of time spent on each activity (hours/week) or participation (yes/no) in an activity by the empirically derived item weights and summing overall activities. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, case management, mobile technologies (mHealth), Physical activities, 6-min walking test, motivational feedback