Future Patient - Telerehabilitation of Patients With Heart Failure II

Heart Failure Clinical Trial

Official title:

Future Patient - Telerehabilitering af Patienter Med Hjertesvigt II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490525
• Other study ID #: N-20200037
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2023
• Source: Aalborg University
• Contact: Birthe Dinesen, PhD,
• Phone: +45 2051 5944
• Email: bid[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Telerehabilitation
Blood pressure (iHealth Neo/BP5s), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), and tablet (iPad Air 2).

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Viborg Regional Hospital	Viborg

Sponsors (8)

Lead Sponsor	Collaborator
Aalborg University	Aage and Johanne Louis-Hansens Foundation, Department of Photonics Engineering, Technical University of Denmark, Department of Psychology, Aarhus University, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Skive Healthcare Center, Viborg Healthcare Center, Viborg Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of the number of visits to the outpatient clinic	Number of visits to the outpatient clinic between intervention and control group	For both intervention and control group: 6 months
Secondary	Number of readmissions	Number of readmissions between intervention and control group	For both intervention and control group: 6 months
Secondary	Number of tele-communicational (phone and video) contacts	Number of phone and video contacts to the healthcare professionals between intervention and control group	For both intervention and control group: 6 months
Secondary	Experiences of HF patients and healthcare professionals with the use of video consultations	Interviews with HF patients and healthcare professionals regrind their experiences with the use of video consultations	Intervention group: at month 6
Secondary	Testing an algorithm on weight based on adherence	Questionnaires about feedback from an algorithm on weight	Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Secondary	Degree of depression	Degree of depression measured through HADS questionnaire	For both intervention and control group: at baseline, 3 months, and 6 months
Secondary	Use of the website "Hjerteportalen.dk"	Use of the website "Hjerteportalen.dk" based on log files	Intervention group: 6 months

External Links

•   Read about project