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Completed

NCT Number: NCT03388918

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.

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Key information

Conditions

Heart Failure NYHA Class I Acute Decompensated Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Ward, Viborg Hospital

Viborg, 8800, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telerehabilitation

Device

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)

Primary outcomes

  1. Increased quality of life

    Time frame: 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

    Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ)

Secondary outcomes

  1. Time from baseline to optimized medical treatment

    Time frame: 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

    Time for optimizing medicine

  2. All cause hospitalization

    Time frame: For both intervention and control group: 6 months

    All-cause hospitalization at end of rehabilitation

  3. Steps taken

    Time frame: Intervention group: Everyday for 12 months

    Numbers of steps taken in the intervention group

  4. Development of bloodpressure

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

    Intervention group: Blood pressure (mmHG)

  5. Development of pulse

    Time frame: Intervention group: Pulse from date of randomization and every day in 12 months

    Intervention group: Pulse ( numbers per minutes)

  6. Development of weight

    Time frame: Intervention group: Weight from date of randomization and every day in 12 months

    Intervention group: Weight (Kilograms)

  7. Sleep

    Time frame: Intervention group: Sleep from date of randomization and accessed up to 12 months

    Intervention group: Sleep ( numbers of hours per night)

  8. Illness perception

    Time frame: For Intervention and control group: At baseline, 6 & 12 months

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

  9. Motivation

    Time frame: For both intervention and control group: At baseline, 6 & 12 months

    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

  10. Anxiety and depression

    Time frame: For both intervention and control group: At baseline, 6 & 12 months

    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

  11. Health- literacy

    Time frame: For both intervention and control group: At baseline

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

  12. eHealth literacy

    Time frame: For both intervention and control group: At baseline, 6 & 12 months

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

  13. Experiences of using the Heart portal

    Time frame: For intervention group: 6 & 12 months

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

  14. Costs of healthcare and rehabilitation services

    Time frame: For both intervention and control group: 6 months

    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

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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