Future Patient - Telerehabilitation of Patients With Heart Failure II

NCT ID: NCT04490525

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-09-01

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).

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telerehabilitation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aage and Johanne Louis-Hansens Foundation

UNKNOWN

Sponsor Role: collaborator

Laboratory of Welfare Technology, Department of Health Science and Technology, AAU

UNKNOWN

Sponsor Role: collaborator

Viborg Regional Hospital

OTHER

Sponsor Role: collaborator

Skive Healthcare Center

UNKNOWN

Sponsor Role: collaborator

Viborg Healthcare Center

UNKNOWN

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Department of Photonics Engineering, Technical University of Denmark

UNKNOWN

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Birthe Dinesen

Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiology, Viborg Regional Hospital

Viborg, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Birthe Dinesen, PhD,

Role: CONTACT

bid@hst.aau.dk

+45 2051 5944

Malene Hollingdal, MD, PhD

Role: CONTACT

malene.hollingdal@midt.rm.dk

78 44 00 00

Facility Contacts

Malene Hollingdahl, Consultant, MD, PhD

Role: primary

malene.hollingdal@viborg.rm.dk

+45 78447053

Related Links

https://www.labwelfaretech.com/en/

Read about project

Other Identifiers

N-20200037

Identifier Type: -

Identifier Source: org_study_id