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Future Patient - Telerehabilitation of Patients With Heart Failure II

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Viborg Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction of the number of visits to the outpatient clinic
Number of visits to the outpatient clinic between intervention and control group
Number of readmissions
Number of readmissions between intervention and control group
Number of tele-communicational (phone and video) contacts
Number of phone and video contacts to the healthcare professionals between intervention and control group
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
Testing an algorithm on weight based on adherence
Questionnaires about feedback from an algorithm on weight
Degree of depression
Degree of depression measured through HADS questionnaire
Use of the website "Hjerteportalen.dk"
Use of the website "Hjerteportalen.dk" based on log files

Full Information

First Posted
July 19, 2020
Last Updated
July 18, 2023
Sponsor
Aalborg University
Collaborators
Aage and Johanne Louis-Hansens Foundation, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Viborg Regional Hospital, Skive Healthcare Center, Viborg Healthcare Center, Department of Psychology, Aarhus University, Department of Photonics Engineering, Technical University of Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04490525
Brief Title
Future Patient - Telerehabilitation of Patients With Heart Failure II
Official Title
Future Patient - Telerehabilitering af Patienter Med Hjertesvigt II
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Aage and Johanne Louis-Hansens Foundation, Laboratory of Welfare Technology, Department of Health Science and Technology, AAU, Viborg Regional Hospital, Skive Healthcare Center, Viborg Healthcare Center, Department of Psychology, Aarhus University, Department of Photonics Engineering, Technical University of Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Telerehabilitation
Intervention Description
Blood pressure (iHealth Neo/BP5s), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), and tablet (iPad Air 2).
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
15 % increase in health-related quality of life measured by HeartQoL
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
Secondary Outcome Measure Information:
Title
Reduction of the number of visits to the outpatient clinic
Description
Number of visits to the outpatient clinic between intervention and control group
Time Frame
For both intervention and control group: 6 months
Title
Number of readmissions
Description
Number of readmissions between intervention and control group
Time Frame
For both intervention and control group: 6 months
Title
Number of tele-communicational (phone and video) contacts
Description
Number of phone and video contacts to the healthcare professionals between intervention and control group
Time Frame
For both intervention and control group: 6 months
Title
Experiences of HF patients and healthcare professionals with the use of video consultations
Description
Interviews with HF patients and healthcare professionals regrind their experiences with the use of video consultations
Time Frame
Intervention group: at month 6
Title
Testing an algorithm on weight based on adherence
Description
Questionnaires about feedback from an algorithm on weight
Time Frame
Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Title
Degree of depression
Description
Degree of depression measured through HADS questionnaire
Time Frame
For both intervention and control group: at baseline, 3 months, and 6 months
Title
Use of the website "Hjerteportalen.dk"
Description
Use of the website "Hjerteportalen.dk" based on log files
Time Frame
Intervention group: 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birthe Dinesen, PhD,
Phone
+45 2051 5944
Email
bid@hst.aau.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Malene Hollingdal, MD, PhD
Phone
78 44 00 00
Email
malene.hollingdal@midt.rm.dk
Facility Information:
Facility Name
Department of Cardiology, Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malene Hollingdahl, Consultant, MD, PhD
Phone
+45 78447053
Email
malene.hollingdal@viborg.rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.labwelfaretech.com/en/
Description
Read about project

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Future Patient - Telerehabilitation of Patients With Heart Failure II

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