NCT03388918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

2.6 years

First QC Date

August 24, 2017

Last Update Submit

May 26, 2021

Conditions

Heart Failure NYHA Class IHeart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure NYHA Class IVAcute Decompensated Heart Failure

Keywords

Quality of lifeTelerehabilitationCardiac patientsHeart failure

Outcome Measures

Primary Outcomes (1)

  • Increased quality of life

    Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ)

    Intervention group: At baseline, week 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32, 34,36,38,40,42,44,46,48,50,52 Control group: Baseline, 6 & 12 months

Secondary Outcomes (14)

  • Time from baseline to optimized medical treatment

    For both intervention and control group: From date of randomization until the date of first documented progression with medical treatment, assessed up to 4 months

  • All cause hospitalization

    For both intervention and control group: 6 months

  • Steps taken

    Intervention group: Everyday for 12 months

  • Development of bloodpressure

    Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months

  • Development of pulse

    Intervention group: Pulse from date of randomization and every day in 12 months

  • +9 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Telerehabilitation

Traditional rehabilitation group

NO INTERVENTION

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.

Interventions

TelerehabilitationDEVICE

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 group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Ward, Viborg Hospital

Viborg, 8800, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 35928510DERIVED

  • 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.

    PMID: 34255642DERIVED

  • 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.

    PMID: 31538944DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Birthe Dinesen, PhD

    Aalborg University

    PRINCIPAL INVESTIGATOR

  • Malene Hollingdal, MD, PhD

    Central Jutland Regional Hospital

    STUDY DIRECTOR

  • Jens Refsgaard, MD, PhD

    Central Jutland Regional Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2017

First Posted

January 3, 2018

Study Start

December 21, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

May 27, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

No plan for sharing protocol as we are applying for patent.

Locations

DK(1)