Chronic Heart Failure, Diabetes Mellitus
Conditions
Keywords
telemedicine, case management, mobile technologies (mHealth), Physical activities, 6-min walking test, motivational feedback
Brief summary
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.
Interventions
OTHERTeleassistance
Support the nursing case manager through a structured teleconsultation program (telephone and videoconference support at least once a week)
OTHERTeleconsultation
Cardiological and Diabetological teleconsultation at the beginning of the program and in case of need during the program.
OTHERTelerehabilitation
Support from a physiotherapist (if needed)
OTHERTelemonitoring
Telemonitoring of patient vital signs (eg single electrocardiographic trace) and delay steps
OTHERmHealth
The support of an App for recording and monitoring parameters: delay treatment, clinical parameters such as glycemia, blood pressure, HR, symptoms, etc.
OTHERtelepsycology
Psychological support (if necessary)
OTHERQuality of life
Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire
OTHERBiochemistry evaluation
Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP
OTHERClinical evaluation
6-minute-walking test, IMC, NYHA class, Ejection fraction
OTHERState of health of the patient
Severity Index and Comordbidity index
Sponsors
Azienda Ospedaliera Bolognini di Seriate Bergamo
Papa Giovanni XXIII Hospital
Istituti Clinici Scientifici Maugeri SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Consenting eligible patients were randomized to either an Intervention or a Control group (1:1). A computer (www.randomization.com) generated tables to allocate patients in fixed blocks of four. In order to prevent selection bias, the list of randomization will be managed by personnel not directly involved in the enrolment of the patient. Due to the nature of the intervention, neither the patients nor the physicians were blinded to patients' group allocation. However, outcome assessors and data analysts will be blinded to the allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tolerance capacity | Baseline and 6 months | The change from baseline in tolerance capacity will be measured by walking test performance (meters walked). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Steps | Baseline and 6 months | The difference in the weekly mean in the number of steps from baseline over the 6 months of follow-up. |
| HbA1c dosage | Baseline and 6 months | Change of the disease status |
| Change in quality of life related to heart failure | Baseline and 6 months | Change in quality of life measured by Minnesota Living with Heart Failure (MLHFQ) questionnaire |
| Change of hospitalizations | 6 months | Change of hospitalizations for cardiovascular problems, diabetes and all-causes |
| Change in quality of life | Baseline and 6 months | Change in quality of life measured by 12-item Short Form Survey (SF-12) questionnaire |
| Assessment of physical activity. | Baseline and 6 months | 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. |
| Change in quality of life related to Diabetes | Baseline and 6 months | Change in quality of life measured by Diabetes quality of life (DQoL) questionnaire |
Countries
Italy
Outcome results
None listed