NCT02668757

Brief Summary

The HeartHab study is a pilot trial in which coronary artery disease patients (n = 15-30) are given the HeartHab application. The HeartHab application is a smarthphone based mobile application that serves as a secondary prevention tool, to support cardiac patients after their phase II cardiac rehabilitation program. During study period (4-6 weeks), participating patients will be asked to use the application. HeartHab includes a module devoted to therapy compliance, one to exercise training prescription and one to risk factor control. HeartHab aims to motivate the patient to improve his/her self-management skills and hence decrease cardiovascular morbidity (and mortality). Motivational aspects and usability data will be collected during study period by means of app logs and/or questionnaires/interviews.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2016

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

First Submitted

Initial submission to the registry

January 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

January 27, 2016

Last Update Submit

February 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Impact on motivation

    By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour

    week 6

Secondary Outcomes (1)

  • Usability of the HeartHab application

    week 6

Study Arms (1)

HeartHab application arm

OTHER

Patients in the HeartHab application arm will receive the mobile application during study period.

Behavioral: HeartHab application intervention

Interventions

The intervention patients will use the HeartHab application on a smartphone. During the study, the patients will use the HeartHab application for 4-6 weeks.

HeartHab application arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only.
  • Patients that have completed the standard cardiac rehabilitation program
  • Patients who have access to a computer and a WiFi internet connection
  • Patients that are able to go to the rehabilitation centre ReGo of Jessa Hospital
  • Patients who signed the informed consent document

You may not qualify if:

  • Patients with a history of VF, sustained VT and/or supraventricular tachycardia during the last 6 months before enrollment.
  • Patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle.
  • Patients with a pacemaker or defibrillator.
  • Non-Dutch speaking patients
  • Patients who simultaneously participate in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Ziekenhuis

Hasselt, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Paul Dendale, Prof. dr.

    paul.dendale@jessazh.be

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

January 27, 2016

First Posted

January 29, 2016

Study Start

March 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations