Future Patient - Telerehabilitation of Heart Failure Patients

Acute Decompensated Heart Failure Clinical Trial

Official title:

Future Patient - Telerehabilitation of Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388918
• Other study ID #: N-20160055
• Status: Completed
• Phase: N/A
• Start date: December 21, 2016
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2021
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Denmark	Cardiology Ward, Viborg Hospital	Viborg

Sponsors (12)

Lead Sponsor

Collaborator

Aalborg University

Aage og Johanne Louis-Hansens Fond, Danish Heart Foundation, Department of Computer Science, AAU, Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University, Odense University Hospital, Regionshospitalet Viborg, Skive, Skive Healthcare Center, Technical University of Denmark, University of Aarhus, Viborg Healthcare Center, Viewcare A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All cause hospitalization	All-cause hospitalization at end of rehabilitation	For both intervention and control group: 6 months
Secondary	Steps taken	Numbers of steps taken in the intervention group	Intervention group: Everyday for 12 months
Secondary	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
Secondary	Development of pulse	Intervention group: Pulse ( numbers per minutes)	Intervention group: Pulse from date of randomization and every day in 12 months
Secondary	Development of weight	Intervention group: Weight (Kilograms)	Intervention group: Weight from date of randomization and every day in 12 months
Secondary	Sleep	Intervention group: Sleep ( numbers of hours per night)	Intervention group: Sleep from date of randomization and accessed up to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Read more about the trial at the homepage for the Laboratory for Welfare Technology - telehealth and telerehabilitation, Aalborg University