Future Patient - Telerehabilitation of Patients With Heart Failure II
- Conditions
- Heart Failure
- Interventions
- Device: Telerehabilitation
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
- Arm && Interventions
Group Intervention Description Intervention Telerehabilitation The intervention group will participate in the telerehabilitation program (please see detailed description of telerehabilitation program and technologies). The two steps in the telerehabilitation program last up to six months depending on how fast the titration of medicine in step one will be conducted. The intervention group will spend 5-10 minutes every day on monitoring themselves. Every month, an online questionnaire has to be filled in which will take up to 5 minutes. At enrolment, after titration of medicine, and the end of rehabilitation, the patient will fill in an online questionnaire. This will take 5 minutes each time. Selected patients and relatives will be asked if they wish to participate in interviews after participation in the trial. Each interview will last less than one hour. Number of interviews will be decided when data saturation has been achieved.
- 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 Use of the website "Hjerteportalen.dk" Intervention group: 6 months Use of the website "Hjerteportalen.dk" based on log files
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
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
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
Trial Locations
- Locations (1)
Department of Cardiology, Viborg Regional Hospital
🇩🇰Viborg, Denmark