Future Patient - Telerehabilitation of Heart Failure Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Future Patient - Telerehabilitation of Heart Failure Patients

Conditions
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Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Acute Decompensated Heart Failure

Intervention / Treatment
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* Device: Telerehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Device: Telerehabilitation<br>* 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)<br>|
| No Intervention: Traditional rehabilitation group<br>This group follows the International Cardiac Guidelines. There are three steps in this arm: Step I: Titration of medicine (3 months). Step II: Traditional rehabilitation at the healthcare center ( 3 months). Step III: Everyday life with HF ( 6 months) The participants do not have access to the Heart Portal and is not monitoring any vital signs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased quality of life | Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from baseline to optimized medical treatment | Time for optimizing medicine | 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 | 
| All cause hospitalization | All-cause hospitalization at end of rehabilitation | For both intervention and control group: 6 months | 
| Steps taken | Numbers of steps taken in the intervention group | Intervention group: Everyday for 12 months | 
| Development of bloodpressure | Intervention group: Blood pressure (mmHG) | Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months | 
| Development of pulse | Intervention group: Pulse ( numbers per minutes) | Intervention group: Pulse from date of randomization and every day in 12 months | 
| Development of weight | Intervention group: Weight (Kilograms) | Intervention group: Weight from date of randomization and every day in 12 months | 
| Sleep | Intervention group: Sleep ( numbers of hours per night) | Intervention group: Sleep from date of randomization and accessed up to 12 months | 
| Illness perception | Positive changes in illness perceptions, from dysfunctional to functional measured by Illness perception questionaire | For Intervention and control group: At baseline, 6 & 12 months | 
| Motivation | 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 | For both intervention and control group: At baseline, 6 & 12 months | 
| Anxiety and depression | 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 | For both intervention and control group: At baseline, 6 & 12 months | 
| Health- literacy | Health literacy in intervention and control group measured by Health Literacy Questionnaire (Danish validated version HLQ) by units on a scale | For both intervention and control group: At baseline | 
| eHealth literacy | Improvement in e-health literacy in intervention and control group measured by eHealth Literacy Questionnaire (Danish validated version eHLQ) by units on a scale | For both intervention and control group: At baseline, 6 & 12 months | 
| Experiences of using the Heart portal | Qualitative exploration of experiences of HF patients, relatives and healthcare professionals use of the Heart portal | For intervention group: 6 & 12 months | 
| Costs of healthcare and rehabilitation services | 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 | For both intervention and control group: 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Telerehabilitation, Cardiac patients, Heart failure