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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
163
Support the nursing case manager through a structured teleconsultation program (telephone and videoconference support at least once a week)
Cardiological and Diabetological teleconsultation at the beginning of the program and in case of need during the program.
Support from a physiotherapist (if needed)
Telemonitoring of patient vital signs (eg single electrocardiographic trace) and delay steps
The support of an App for recording and monitoring parameters: delay treatment, clinical parameters such as glycemia, blood pressure, HR, symptoms, etc.
Psychological support (if necessary)
Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire
Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP
6-minute-walking test, IMC, NYHA class, Ejection fraction
Severity Index and Comordbidity index
Azienda Ospedaliera Bolognini di Seriate Bergamo
Seriate, Bergamo, Italy
Istituti Clinici Scientifici Maugeri
Lumezzane, Brescia, Italy
Papa Giovanni XXIII Hospital
Bergamo, Italy
Change in tolerance capacity
The change from baseline in tolerance capacity will be measured by walking test performance (meters walked).
Time frame: Baseline and 6 months
Change of hospitalizations
Change of hospitalizations for cardiovascular problems, diabetes and all-causes
Time frame: 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.
Time frame: Baseline and 6 months
HbA1c dosage
Change of the disease status
Time frame: 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
Time frame: 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
Time frame: Baseline and 6 months
Change in quality of life
Change in quality of life measured by 12-item Short Form Survey (SF-12) questionnaire
Time frame: 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.
Time frame: Baseline and 6 months
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