Future Patient - Telerehabilitation of Heart Failure Patients
- Conditions
- Heart Failure NYHA Class IHeart Failure NYHA Class IIHeart Failure NYHA Class IVAcute Decompensated Heart FailureHeart Failure NYHA Class III
- Interventions
- Device: Telerehabilitation
- Registration Number
- NCT03388918
- Lead Sponsor
- Aalborg University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Telerehabilitation 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Steps taken Intervention group: Everyday for 12 months Numbers of steps taken in the intervention group
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)
All cause hospitalization For both intervention and control group: 6 months All-cause hospitalization at end of rehabilitation
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)
Sleep Intervention group: Sleep from date of randomization and accessed up to 12 months Intervention group: Sleep ( numbers of hours per night)
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
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
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
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
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
Trial Locations
- Locations (1)
Cardiology Ward, Viborg Hospital
🇩🇰Viborg, Denmark