Future Patient - Telerehabilitation of Heart Failure Patients

NCT ID: NCT03388918

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-21
• Study Completion Date: 2019-08-01

Brief Summary

The idea behind the Future Patient research project is to develop a telerehabilitation program and tools for patients with heart failure.

The hypothesis for this study is that participation in a telerehabilitation program for patients with heart failure will increase the patients' quality of life and multi-parametric (subjective and objective) individualized monitoring in a telerehabilitation program for patients with heart failure will increase detection of worsening of symptoms and avoid future hospitalization of the HF-patients.

Detailed Description

The overall aim is to test, implement and evaluate a telerehabilitation program for patients with heart failure from clinical, psychosocial, health literacy and e-health literacy, inter-organizational, health economic and technical perspectives.

Furthermore, this study has sub aims:

• To increase the quality of life for patients with Heart Failure (HF)
• To optimize the medical treatment of patients with HF
• To perform multi-parametric (subjective and objective) individualized monitoring in order to detect worsening of symptoms and avoid hospitalizations
• To increase physical activities for patients with heart failure in everyday life in a telerehabilitation program
• To facilitate patient-initiated self-care management actions upon the following early detection of changes in source data (steps taken, weight, blood pressure, pulse, sleep, illness perception, motivation, anxiety and depression)
• To evaluate patients health literacy and e-health literacy participating in a telerehabilitation program and rehabilitation program
• To test and evaluate the Heart Portal - a digital toolbox for improved self-management for patients with heart failure and their relatives
• To explore the experiences and perspectives of the patients and their relatives when being part of a telerehabilitation program
• To test and evaluate a cross sector communication platform from a patient and healthcare professional perspective
• To perform a cost-effectiveness analysis of total costs of healthcare and rehabilitation services

Conditions

Heart Failure NYHA Class I; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Acute Decompensated Heart Failure

Study Design

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

Study Groups

Intervention group

The intervention group has three steps:

Step I: Titration of medicine ( 0-3 months)

Step II: Telerehabilitation program at healthcare center or by call center ( 3 months)

Step III: Rehabilitation in everyday life ( 6 months)

The patients is monitoring vital signs such as blood pressure, pulse, weight, steps, respiration, and sleep. Have access to a Heart Portal that is an information cite on heart failure. Via the portal patients can see measured values & communicate with staff. Every other week the patients fill in an online questionnaires on symptoms, sleep and well being.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: DEVICE

Blood pressure (A\&D Medical UA 767PBT), weight (A\&D Medical UC-321PBT), step counters(Fitbit Zip \& Charge), sleep sensor (Beddit 3), tablet (iPAD Air 2) \& transmitter (Qualcomm Life, QWH-HUB-V1.0E)

Traditional rehabilitation group

This group follows the International Cardiac Guidelines. There are three steps in this arm:

Step I: Titration of medicine (3 months).

Step II: Traditional rehabilitation at the healthcare center ( 3 months).

Step III: Everyday life with HF ( 6 months)

The participants do not have access to the Heart Portal and is not monitoring any vital signs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telerehabilitation

Blood pressure (A\&D Medical UA 767PBT), weight (A\&D Medical UC-321PBT), step counters(Fitbit Zip \& Charge), sleep sensor (Beddit 3), tablet (iPAD Air 2) \& transmitter (Qualcomm Life, QWH-HUB-V1.0E)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with HF according to New York Heart Association (NYHA) Class I-IV with max 20 % in class I or who have a current hospitalization for acute decompensated HF within the past two weeks
• Adults (18 years or older); no upper age limit
• Patients living in Viborg and Skive Municipality
• Living at home and capable of caring for him/herself
• Have basic computer skills or a relative who have basic computer skills
• Informed consent to participate in a telerehabilitation program
• May have a pacemaker

Exclusion Criteria

• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• 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 Danish

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

Sponsors

Aage og Johanne Louis-Hansens Fond

OTHER

Sponsor Role: collaborator

Viewcare A/S

UNKNOWN

Sponsor Role: collaborator

Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University

UNKNOWN

Sponsor Role: collaborator

Regionshospitalet Viborg, Skive

OTHER

Sponsor Role: collaborator

Technical University of Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Danish Heart Foundation

OTHER

Sponsor Role: collaborator

Viborg Healthcare Center

UNKNOWN

Sponsor Role: collaborator

Skive Healthcare Center

UNKNOWN

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Department of Computer Science, AAU

UNKNOWN

Sponsor Role: collaborator

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Birthe Dinesen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birthe Dinesen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Malene Hollingdal, MD, PhD

Role: STUDY_DIRECTOR

Central Jutland Regional Hospital

Jens Refsgaard, MD, PhD

Role: STUDY_DIRECTOR

Central Jutland Regional Hospital

Locations

Cardiology Ward, Viborg Hospital

Viborg, , Denmark

Countries

Denmark

References

Spindler H, Dyrvig AK, Schacksen CS, Anthonimuthu D, Frost L, Gade JD, Kronborg SH, Mahboubi K, Refsgaard J, Dinesen B, Hollingdal M, Kayser L. Increased motivation for and use of digital services in heart failure patients participating in a telerehabilitation program: a randomized controlled trial. Mhealth. 2022 Jul 20;8:25. doi: 10.21037/mhealth-21-56. eCollection 2022.

Reference Type: DERIVED

PMID: 35928510 (View on PubMed)

Skov Schacksen C, Dyrvig AK, Henneberg NC, Dam Gade J, Spindler H, Refsgaard J, Hollingdal M, Dittman L, Dremstrup K, Dinesen B. Patient-Reported Outcomes From Patients With Heart Failure Participating in the Future Patient Telerehabilitation Program: Data From the Intervention Arm of a Randomized Controlled Trial. JMIR Cardio. 2021 Jul 2;5(2):e26544. doi: 10.2196/26544.

Reference Type: DERIVED

PMID: 34255642 (View on PubMed)

Dinesen B, Dittmann L, Gade JD, Jorgensen CK, Hollingdal M, Leth S, Melholt C, Spindler H, Refsgaard J. "Future Patient" Telerehabilitation for Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Sep 19;8(9):e14517. doi: 10.2196/14517.

Reference Type: DERIVED

PMID: 31538944 (View on PubMed)

Other Identifiers

N-20160055

Identifier Type: -

Identifier Source: org_study_id