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Future Patient - Telerehabilitation of Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT03388918
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Aage og Johanne Louis-Hansens Fond
Viewcare A/S
Laboratory of Welfare Technologies – Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University
Regionshospitalet Viborg, Skive
Danish Technical University
University of Aarhus
Danish Heart Foundation
Viborg Healthcare Center
Skive Healthcare Center
CIMT, Odense University Hospital, Odense
Department of Computer Science, AAU
Information provided by (Responsible Party):
Birthe Dinesen, Aalborg University

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.


Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class I Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV Acute Decompensated Heart Failure Device: Telerehabilitation Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Future Patient - Telerehabilitation of Heart Failure Patients
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388918


Contacts
Contact: Birthe Dinesen, PhD 004520515944 bid@hst.aau.dk
Contact: Malene Hollingdal, MD, PhD malene.hollingdal@midt.rm.dk

Locations
Denmark
Cardiology Ward, Viborg Hospital Recruiting
Viborg, Denmark, 8800
Contact: Malene Hollingdal, MD, PhD       malene.hollingdal@midt.rm.dk   
Contact: Jens Refsgaard, MD, PhD       jens.refsgaard@viborg.rm.dk   
Principal Investigator: Malene Hollingdal, MD, PhD         
Sponsors and Collaborators
Aalborg University
Aage og Johanne Louis-Hansens Fond
Viewcare A/S
Laboratory of Welfare Technologies – Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University
Regionshospitalet Viborg, Skive
Danish Technical University
University of Aarhus
Danish Heart Foundation
Viborg Healthcare Center
Skive Healthcare Center
CIMT, Odense University Hospital, Odense
Department of Computer Science, AAU
Investigators
Principal Investigator: Birthe Dinesen, PhD Aalborg University
Study Director: Malene Hollingdal, MD, PhD Central Jutland Regional Hospital
Study Director: Jens Refsgaard, MD, PhD Central Jutland Regional Hospital

Additional Information:
Responsible Party: Birthe Dinesen, Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT03388918     History of Changes
Other Study ID Numbers: N-20160055
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan for sharing protocol as we are applying for patent.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Birthe Dinesen, Aalborg University:
Quality of life
Telerehabilitation
Cardiac patients
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases