Future Patient - Telerehabilitation of Patients With Heart Failure II

Future Patient - Telerehabilitering af Patienter Med Hjertesvigt II

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Telerehabilitation

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).

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birthe Dinesen, PhD,; Phone Number: +45 2051 5944; Email: bid@hst.aau.dk
• Study Contact Backup: Name: Malene Hollingdal, MD, PhD; Phone Number: 78 44 00 00; Email: malene.hollingdal@midt.rm.dk

Study Locations

• Denmark
  • Viborg, Denmark, 8800
    • Recruiting
    • Department of Cardiology, Viborg Regional Hospital
    • Contact: Malene Hollingdahl, Consultant, MD, PhD; Phone Number: +45 78447053; Email: malene.hollingdal@viborg.rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The 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.	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).
No Intervention: Control; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of readmissions	Number of readmissions between intervention and control group	For both intervention and control group: 6 months
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
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
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
Degree of depression	Degree of depression measured through HADS questionnaire	For both intervention and control group: at baseline, 3 months, and 6 months
Use of the website "Hjerteportalen.dk"	Use of the website "Hjerteportalen.dk" based on log files	Intervention group: 6 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Read about project

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: N-20200037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No