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Clinical Trials/NCT04490525
NCT04490525
Recruiting
N/A

Future Patient - Telerehabilitering af Patienter Med Hjertesvigt II

Aalborg University1 site in 1 country70 target enrollmentSeptember 1, 2020
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Aalborg University
Enrollment
70
Locations
1
Primary Endpoint
Health-related quality of life
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of the study is to test and evaluate the use of video consultations and an algorithm for weight gain and loss in the Future Patient Telerehabilitation program for HF patients in an RCT.

Detailed Description

Next steps The Future Patient study - telerehabilitation of HF patients II Based on the preliminary results from FP I (being published fall 2020) and a review of literature, the investigators would like to improve our telerehabilitation program and technologies in order to prepare for implementation of the FTP and technologies. * The HF patients in FP I expressed that the KCCQ was too long when having to complete the questionnaire every other week. Therefore, the investigators would like to test a shorter questionnaire HeartQoL (ESC) as a patient-reported outcome tool every month. * Video consultations instead of physical meetings with doctors and nurses at the hospital. Currently, there is a lack of evidence regarding the use of video to decrease physical visits at the hospitals instead of video consultations. * Test of algorithms for detecting an increase in weight on two days following clinical cardiac guidelines (Ponikowski et al 2016).

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
September 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Birthe Dinesen

Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation

Aalborg University

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with HF NYHA Class II-IV, who have a current hospitalization for acute decompensated HF or a visit to the HF outpatient clinic within the past two weeks
  • Patients with an EF of 40% or less
  • Adults (18 years or older); no upper age limit
  • Patients living in Viborg and Skive Municipality
  • Patients living at home and capable of caring for themselves
  • Have basic computer skills or a relative who have basic computer skills

Exclusion Criteria

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Present and 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/read/understand Danish

Outcomes

Primary Outcomes

Health-related quality of life

Time Frame: Intervention: at baseline, after 1 month, after 2 months, after 3 months, after 4 months, after 5 months, after 6 months. Control: baseline, after 3 months, after 6 months

15 % increase in health-related quality of life measured by HeartQoL

Secondary Outcomes

  • Testing an algorithm on weight based on adherence(Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26)
  • Number of readmissions(For both intervention and control group: 6 months)
  • Degree of depression(For both intervention and control group: at baseline, 3 months, and 6 months)
  • Experiences of HF patients and healthcare professionals with the use of video consultations(Intervention group: at month 6)
  • Reduction of the number of visits to the outpatient clinic(For both intervention and control group: 6 months)
  • Number of tele-communicational (phone and video) contacts(For both intervention and control group: 6 months)
  • Use of the website "Hjerteportalen.dk"(Intervention group: 6 months)

Study Sites (1)

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