Future Patient - Telerehabilitation of Heart Failure Patients

Aalborg University

Status: Completed

Conditions: Heart Failure NYHA Class II; Acute Decompensated Heart Failure; Heart Failure NYHA Class IV; Heart Failure NYHA Class III; Heart Failure NYHA Class I

Treatments: Device: Telerehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03388918

N-20160055

Details and patient eligibility

About

The idea behind the Future Patient research project is to develop a telerehabilitation program and tools for patients with heart failure.

The hypothesis for this study is that participation in a telerehabilitation program for patients with heart failure will increase the patients' quality of life and multi-parametric (subjective and objective) individualized monitoring in a telerehabilitation program for patients with heart failure will increase detection of worsening of symptoms and avoid future hospitalization of the HF-patients.

Full description

The overall aim is to test, implement and evaluate a telerehabilitation program for patients with heart failure from clinical, psychosocial, health literacy and e-health literacy, inter-organizational, health economic and technical perspectives.

Furthermore, this study has sub aims:

• To increase the quality of life for patients with Heart Failure (HF)
• To optimize the medical treatment of patients with HF
• To perform multi-parametric (subjective and objective) individualized monitoring in order to detect worsening of symptoms and avoid hospitalizations
• To increase physical activities for patients with heart failure in everyday life in a telerehabilitation program
• To facilitate patient-initiated self-care management actions upon the following early detection of changes in source data (steps taken, weight, blood pressure, pulse, sleep, illness perception, motivation, anxiety and depression)
• To evaluate patients health literacy and e-health literacy participating in a telerehabilitation program and rehabilitation program
• To test and evaluate the Heart Portal - a digital toolbox for improved self-management for patients with heart failure and their relatives
• To explore the experiences and perspectives of the patients and their relatives when being part of a telerehabilitation program
• To test and evaluate a cross sector communication platform from a patient and healthcare professional perspective
• To perform a cost-effectiveness analysis of total costs of healthcare and rehabilitation services

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with HF according to New York Heart Association (NYHA) Class I-IV with max 20 % in class I or who have a current hospitalization for acute decompensated HF within the past two weeks
• Adults (18 years or older); no upper age limit
• Patients living in Viborg and Skive Municipality
• Living at home and capable of caring for him/herself
• Have basic computer skills or a relative who have basic computer skills
• Informed consent to participate in a telerehabilitation program
• May have a pacemaker

Exclusion criteria

• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Previous neurologic, musculoskeletal or cognitive disability or active psychiatric history (as noted in the medical record) other than depression or anxiety related to cardiac or other chronic illness
• Lack of ability to cooperate
• Does not speak Danish

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group has three steps: Step I: Titration of medicine ( 0-3 months) Step II: Telerehabilitation program at healthcare center or by call center ( 3 months) Step III: Rehabilitation in everyday life ( 6 months) The patients is monitoring vital signs such as blood pressure, pulse, weight, steps, respiration, and sleep. Have access to a Heart Portal that is an information cite on heart failure. Via the portal patients can see measured values \& communicate with staff. Every other week the patients fill in an online questionnaires on symptoms, sleep and well being.

Treatment:

Device: Telerehabilitation

Traditional rehabilitation group

No Intervention group

Description:

This group follows the International Cardiac Guidelines. There are three steps in this arm: Step I: Titration of medicine (3 months). Step II: Traditional rehabilitation at the healthcare center ( 3 months). Step III: Everyday life with HF ( 6 months) The participants do not have access to the Heart Portal and is not monitoring any vital signs.