Acute Decompensated Heart Failure, Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Conditions
Keywords
Quality of life, Telerehabilitation, Cardiac patients, Heart failure
Brief summary
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.
Detailed 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
Interventions
DEVICETelerehabilitation
Blood pressure (A&D Medical UA 767PBT), weight (A&D Medical UC-321PBT), step counters(Fitbit Zip & Charge), sleep sensor (Beddit 3), tablet (iPAD Air 2) & transmitter (Qualcomm Life, QWH-HUB-V1.0E)
Sponsors
Aage og Johanne Louis-Hansens Fond
Viewcare A/S
Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University
Regionshospitalet Viborg, Skive
Technical University of Denmark
University of Aarhus
Danish Heart Foundation
Viborg Healthcare Center
Skive Healthcare Center
Odense University Hospital
Department of Computer Science, AAU
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increased quality of life | Intervention group: At baseline, week 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32, 34,36,38,40,42,44,46,48,50,52 Control group: Baseline, 6 & 12 months | Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from baseline to optimized medical treatment | For both intervention and control group: From date of randomization until the date of first documented progression with medical treatment, assessed up to 4 months | Time for optimizing medicine |
| All cause hospitalization | For both intervention and control group: 6 months | All-cause hospitalization at end of rehabilitation |
| Steps taken | Intervention group: Everyday for 12 months | Numbers of steps taken in the intervention group |
| Development of bloodpressure | Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months | Intervention group: Blood pressure (mmHG) |
| Development of pulse | Intervention group: Pulse from date of randomization and every day in 12 months | Intervention group: Pulse ( numbers per minutes) |
| Development of weight | Intervention group: Weight from date of randomization and every day in 12 months | Intervention group: Weight (Kilograms) |
| Sleep | Intervention group: Sleep from date of randomization and accessed up to 12 months | Intervention group: Sleep ( numbers of hours per night) |
| Illness perception | For Intervention and control group: At baseline, 6 & 12 months | Positive changes in illness perceptions, from dysfunctional to functional measured by Illness perception questionaire |
| Motivation | For both intervention and control group: At baseline, 6 & 12 months | Changes from extrinsic to intrinsic motivation measured from baseline to end of rehabilitation and 6 months after end of rehabilitation measured by Health Climate Change Questionaire |
| Anxiety and depression | For both intervention and control group: At baseline, 6 & 12 months | Explore whether levels of anxiety and depression in the intervention group are lower or equivalent to the control group measured by Hospital Anxiety and Depression Scale (HADS) questionnaire |
| Health- literacy | For both intervention and control group: At baseline | Health literacy in intervention and control group measured by Health Literacy Questionnaire (Danish validated version HLQ) by units on a scale |
| eHealth literacy | For both intervention and control group: At baseline, 6 & 12 months | Improvement in e-health literacy in intervention and control group measured by eHealth Literacy Questionnaire (Danish validated version eHLQ) by units on a scale |
| Experiences of using the Heart portal | For intervention group: 6 & 12 months | Qualitative exploration of experiences of HF patients, relatives and healthcare professionals use of the Heart portal |
| Costs of healthcare and rehabilitation services | For both intervention and control group: 6 months | Number of hospitalizations, number of contacts with heart failure clinic, days at hospital, contacts with general practitioners, number of participations in rehabilitation activities at healthcare center between intervention and control group |
Countries
Denmark
Outcome results
None listed