Clinical trial NCT04490525: Future Patient - Telerehabilitation of Patients With Heart Failure II
Official title: Future Patient - Telerehabilitering af Patienter Med Hjertesvigt II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Aage and Johanne Louis-Hansens Foundation
name: Laboratory of Welfare Technology, Department of Health Science and Technology, AAU
name: Viborg Regional Hospital
name: Skive Healthcare Center
name: Viborg Healthcare Center
name: University of Aarhus
name: Department of Photonics Engineering, Technical University of Denmark
First posted: 2020-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Health-related quality of life
timeFrame: 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
Secondary outcomes:
measure: Reduction of the number of visits to the outpatient clinic
timeFrame: For both intervention and control group: 6 months
measure: Number of readmissions
timeFrame: For both intervention and control group: 6 months
measure: Number of tele-communicational (phone and video) contacts
timeFrame: For both intervention and control group: 6 months
measure: Experiences of HF patients and healthcare professionals with the use of video consultations
timeFrame: Intervention group: at month 6
measure: Testing an algorithm on weight based on adherence
timeFrame: Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
measure: Degree of depression
timeFrame: For both intervention and control group: at baseline, 3 months, and 6 months
measure: Use of the website "Hjerteportalen.dk"
timeFrame: Intervention group: 6 months
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Department of Cardiology, Viborg Regional Hospital
Study officials:
References: