NCT05633784

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure
• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Teleassistance	Support the nursing case manager through a structured teleconsultation program (telephone and videoconference support at least once a week)
OTHER	Teleconsultation	Cardiological and Diabetological teleconsultation at the beginning of the program and in case of need during the program.
OTHER	Telerehabilitation	Support from a physiotherapist (if needed)
OTHER	Telemonitoring	Telemonitoring of patient vital signs (eg single electrocardiographic trace) and delay steps
OTHER	mHealth	The support of an App for recording and monitoring parameters: delay treatment, clinical parameters such as glycemia, blood pressure, HR, symptoms, etc.
OTHER	telepsycology	Psychological support (if necessary)
OTHER	Quality of life	Minnesota LIVING WITH HEART FAILURE® Questionnaire (MLHFQ), Short Form Survey (SF-12) Questionnaire and Diabetes Quality of Life (DQoL) questionnaire
OTHER	Biochemistry evaluation	Glycemia, glycated haemoglobin, total cholesterol, HDL and LDL, triglycerides, creatinine, BUN, creatinine clearance, BNP
OTHER	Clinical evaluation	6-minute-walking test, IMC, NYHA class, Ejection fraction
OTHER	State of health of the patient	Severity Index and Comordbidity index

Timeline

• Start date: 2022-08-18
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2022-12-01
• Last updated: 2024-11-01

Locations

3 sites across 1 country: Italy