Future Patient - Telerehabilitation of Heart Failure Patients

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

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.

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

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

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.

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.

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)

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

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

Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months

Positive changes in illness perceptions, from dysfunctional to functional measured by Illness perception questionaire

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

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 in intervention and control group measured by Health Literacy Questionnaire (Danish validated version HLQ) by units on a scale

Improvement in e-health literacy in intervention and control group measured by eHealth Literacy Questionnaire (Danish validated version eHLQ) by units on a scale

Qualitative exploration of experiences of HF patients, relatives and healthcare professionals use of the Heart portal

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

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

Spindler H, Dyrvig AK, Schacksen CS, Anthonimuthu D, Frost L, Gade JD, Kronborg SH, Mahboubi K, Refsgaard J, Dinesen B, Hollingdal M, Kayser L. Increased motivation for and use of digital services in heart failure patients participating in a telerehabilitation program: a randomized controlled trial. Mhealth. 2022 Jul 20;8:25. doi: 10.21037/mhealth-21-56. eCollection 2022.

Skov Schacksen C, Dyrvig AK, Henneberg NC, Dam Gade J, Spindler H, Refsgaard J, Hollingdal M, Dittman L, Dremstrup K, Dinesen B. Patient-Reported Outcomes From Patients With Heart Failure Participating in the Future Patient Telerehabilitation Program: Data From the Intervention Arm of a Randomized Controlled Trial. JMIR Cardio. 2021 Jul 2;5(2):e26544. doi: 10.2196/26544.

Dinesen B, Dittmann L, Gade JD, Jorgensen CK, Hollingdal M, Leth S, Melholt C, Spindler H, Refsgaard J. "Future Patient" Telerehabilitation for Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Sep 19;8(9):e14517. doi: 10.2196/14517.