Future Patient - Telerehabilitation of Patients With Heart Failure II
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Sep 2020
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJuly 19, 2023
July 1, 2023
4 years
July 19, 2020
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Health-related quality of life
15 % increase in health-related quality of life measured by HeartQoL
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 (7)
Reduction of the number of visits to the outpatient clinic
For both intervention and control group: 6 months
Number of readmissions
For both intervention and control group: 6 months
Number of tele-communicational (phone and video) contacts
For both intervention and control group: 6 months
Experiences of HF patients and healthcare professionals with the use of video consultations
Intervention group: at month 6
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
- +2 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALThe intervention group will participate in the telerehabilitation program (please see detailed description of telerehabilitation program and technologies). The two steps in the telerehabilitation program last up to six months depending on how fast the titration of medicine in step one will be conducted. The intervention group will spend 5-10 minutes every day on monitoring themselves. Every month, an online questionnaire has to be filled in which will take up to 5 minutes. At enrolment, after titration of medicine, and the end of rehabilitation, the patient will fill in an online questionnaire. This will take 5 minutes each time. Selected patients and relatives will be asked if they wish to participate in interviews after participation in the trial. Each interview will last less than one hour. Number of interviews will be decided when data saturation has been achieved.
Control
NO INTERVENTIONThe control group will follow a conventional rehabilitation program (Egstrup et al 2015). The control subjects will participate in medicine titration for 1- 3 months and conventional rehabilitation for 3 months. The participation in the control group will last up to six months. The exact period depends on how fast the titration of medicine is conducted. At enrolment, after titration of medicine, and end of rehabilitation, the patient will fill in a questionnaire. This will take 5 minutes each time.
Interventions
Blood pressure (iHealth Neo/BP5s), weight (iHealth Lina), step counters(Fitbit Inspire \& Charge 3), sleep sensor (Emfit QS), and tablet (iPad Air 2).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aalborg Universitylead
- Aage and Johanne Louis-Hansens Foundationcollaborator
- Laboratory of Welfare Technology, Department of Health Science and Technology, AAUcollaborator
- Viborg Regional Hospitalcollaborator
- Skive Healthcare Centercollaborator
- Viborg Healthcare Centercollaborator
- University of Aarhuscollaborator
- Department of Photonics Engineering, Technical University of Denmarkcollaborator
Study Sites (1)
Department of Cardiology, Viborg Regional Hospital
Viborg, 8800, Denmark
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation
Study Record Dates
First Submitted
July 19, 2020
First Posted
July 29, 2020
Study Start
September 1, 2020
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
July 19, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share