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Clinical Trials/NCT03388918
NCT03388918
Completed
N/A

Future Patient - Telerehabilitation of Heart Failure Patients

Aalborg University1 site in 1 country140 target enrollmentDecember 21, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure NYHA Class I
Sponsor
Aalborg University
Enrollment
140
Locations
1
Primary Endpoint
Increased quality of life
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 21, 2016
End Date
August 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Birthe Dinesen

Professor

Aalborg University

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

Outcomes

Primary Outcomes

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

  • Steps taken(Intervention group: Everyday for 12 months)
  • Development of pulse(Intervention group: Pulse from date of randomization and every day in 12 months)
  • Development of weight(Intervention group: Weight from date of randomization and every day in 12 months)
  • All cause hospitalization(For both intervention and control group: 6 months)
  • Development of bloodpressure(Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months)
  • Sleep(Intervention group: Sleep from date of randomization and accessed up to 12 months)
  • Anxiety and depression(For both intervention and control group: At baseline, 6 & 12 months)
  • eHealth literacy(For both intervention and control group: At baseline, 6 & 12 months)
  • Experiences of using the Heart portal(For intervention group: 6 & 12 months)
  • Costs of healthcare and rehabilitation services(For both intervention and control group: 6 months)
  • Time from baseline to optimized medical treatment(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)
  • Illness perception(For Intervention and control group: At baseline, 6 & 12 months)
  • Motivation(For both intervention and control group: At baseline, 6 & 12 months)
  • Health- literacy(For both intervention and control group: At baseline)

Study Sites (1)

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