Clinical trial NCT03388918: Future Patient - Telerehabilitation of Heart Failure Patients
Official title: Future Patient - Telerehabilitation of Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure NYHA Class I
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Acute Decompensated Heart Failure
Keywords: Quality of life
Telerehabilitation
Cardiac patients
Heart failure
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aage og Johanne Louis-Hansens Fond
name: Viewcare A/S
name: Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University
name: Regionshospitalet Viborg, Skive
name: Technical University of Denmark
name: University of Aarhus
name: Danish Heart Foundation
name: Viborg Healthcare Center
name: Skive Healthcare Center
name: Odense University Hospital
name: Department of Computer Science, AAU
First posted: 2018-01-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Increased quality of life
timeFrame: 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 outcomes:
measure: Time from baseline to optimized medical treatment
timeFrame: 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
measure: All cause hospitalization
timeFrame: For both intervention and control group: 6 months
measure: Steps taken
timeFrame: Intervention group: Everyday for 12 months
measure: Development of bloodpressure
timeFrame: Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months
measure: Development of pulse
timeFrame: Intervention group: Pulse from date of randomization and every day in 12 months
measure: Development of weight
timeFrame: Intervention group: Weight from date of randomization and every day in 12 months
measure: Sleep
timeFrame: Intervention group: Sleep from date of randomization and accessed up to 12 months
measure: Illness perception
timeFrame: For Intervention and control group: At baseline, 6 & 12 months
measure: Motivation
timeFrame: For both intervention and control group: At baseline, 6 & 12 months
measure: Anxiety and depression
timeFrame: For both intervention and control group: At baseline, 6 & 12 months
measure: Health- literacy
timeFrame: For both intervention and control group: At baseline
measure: eHealth literacy
timeFrame: For both intervention and control group: At baseline, 6 & 12 months
measure: Experiences of using the Heart portal
timeFrame: For intervention group: 6 & 12 months
measure: Costs of healthcare and rehabilitation services
timeFrame: For both intervention and control group: 6 months
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Cardiology Ward, Viborg Hospital
Study officials:
affiliation: Aalborg University
name: Birthe Dinesen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Jutland Regional Hospital
name: Malene Hollingdal, MD, PhD
role: STUDY_DIRECTOR
affiliation: Central Jutland Regional Hospital
name: Jens Refsgaard, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.