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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03388918
Other study ID # N-20160055
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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