Future Patient - Telerehabilitation of Heart Failure Patients

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.

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Heart Failure NYHA Class I
• Intervention / Treatment: Device: Telerehabilitation

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Cardiology Ward, Viborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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; 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)
NO_INTERVENTION: Traditional rehabilitation group; 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?

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

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Odense University Hospital; University of Aarhus; Regionshospitalet Viborg, Skive; Danish Heart Foundation; Technical University of Denmark; Aage og Johanne Louis-Hansens Fond; Skive Healthcare Center; Viborg Healthcare Center; Viewcare A/S; Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University; Department of Computer Science, AAU
• Investigators: Study Director: Malene Hollingdal, MD, PhD, Central Jutland Regional Hospital; Study Director: Jens Refsgaard, MD, PhD, Central Jutland Regional Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2016
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: December 25, 2017
• First Posted (ACTUAL): January 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Heart failure; Telerehabilitation; Cardiac patients
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: N-20160055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan for sharing protocol as we are applying for patent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No