Heart Failure
Conditions
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).
Interventions
DEVICETelerehabilitation
Blood pressure (iHealth Neo/BP5s), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), and tablet (iPad Air 2).
Sponsors
Aage and Johanne Louis-Hansens Foundation
Laboratory of Welfare Technology, Department of Health Science and Technology, AAU
Viborg Regional Hospital
Skive Healthcare Center
Viborg Healthcare Center
University of Aarhus
Department of Photonics Engineering, Technical University of Denmark
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Denmark
Contacts
Primary ContactBirthe Dinesen, PhD,
Backup ContactMalene Hollingdal, MD, PhD
Outcome results
None listed