Future Patient - Telerehabilitation of Patients With Heart Failure II

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT04490525
• Lead Sponsor: Aalborg University

Brief Summary

The aim of the study is to test and evaluate the use of video consultations and an algorithm for weight gain and loss in the Future Patient Telerehabilitation program for HF patients in an RCT.

Detailed Description

Next steps The Future Patient study - telerehabilitation of HF patients II

Based on the preliminary results from FP I (being published fall 2020) and a review of literature, the investigators would like to improve our telerehabilitation program and technologies in order to prepare for implementation of the FTP and technologies.

* The HF patients in FP I expressed that the KCCQ was too long when having to complete the questionnaire every other week. Therefore, the investigators would like to test a shorter questionnaire HeartQoL (ESC) as a patient-reported outcome tool every month.

* Video consultations instead of physical meetings with doctors and nurses at the hospital. Currently, there is a lack of evidence regarding the use of video to decrease physical visits at the hospitals instead of video consultations.

* Test of algorithms for detecting an increase in weight on two days following clinical cardiac guidelines (Ponikowski et al 2016).

Study Timeline

• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-29
• Study Start: 2020-09-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients diagnosed with HF NYHA Class II-IV, who have a current hospitalization for acute decompensated HF or a visit to the HF outpatient clinic within the past two weeks
• Patients with an EF of 40% or less
• Adults (18 years or older); no upper age limit
• Patients living in Viborg and Skive Municipality
• Patients living at home and capable of caring for themselves
• Have basic computer skills or a relative who have basic computer skills

Exclusion Criteria

• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Present and 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/read/understand Danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	Intervention: at baseline, after 1 month, after 2 months, after 3 months, after 4 months, after 5 months, after 6 months. Control: baseline, after 3 months, after 6 months	15 % increase in health-related quality of life measured by HeartQoL

Secondary Outcome Measures

Name	Time	Method
Testing an algorithm on weight based on adherence	Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26	Questionnaires about feedback from an algorithm on weight
Number of readmissions	For both intervention and control group: 6 months	Number of readmissions between intervention and control group
Degree of depression	For both intervention and control group: at baseline, 3 months, and 6 months	Degree of depression measured through HADS questionnaire
Reduction of the number of visits to the outpatient clinic	For both intervention and control group: 6 months	Number of visits to the outpatient clinic between intervention and control group
Number of tele-communicational (phone and video) contacts	For both intervention and control group: 6 months	Number of phone and video contacts to the healthcare professionals between intervention and control group
Use of the website "Hjerteportalen.dk"	Intervention group: 6 months	Use of the website "Hjerteportalen.dk" based on log files
Experiences of HF patients and healthcare professionals with the use of video consultations	Intervention group: at month 6	Interviews with HF patients and healthcare professionals regrind their experiences with the use of video consultations

Trial Locations

Locations (1)

Department of Cardiology, Viborg Regional Hospital; 🇩🇰 Viborg, Denmark