HeartHab, Can a Patient-tailored Application Support Coronary Artery Disease Patients During Rehabilitation? (HeartHab)

February 26, 2018 updated by: prof. dr. Paul Dendale, Hasselt University

Pilot Study, How the HeartHab Application Can Support Coronary Artery Disease Patients in Their Rehabilitation Program?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium
        • Jessa ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HeartHab application arm
Patients in the HeartHab application arm will receive the mobile application during study period.
Behavioral: HeartHab application intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on motivation
Time Frame: week 6
By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour
week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the HeartHab application
Time Frame: week 6
By means of a questionnaire and an interview, the participants are asked about the usability of the application. This information will give insights in parts of the application that could be improved considering the usability
week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Investigators

  • Principal Investigator: Paul Dendale, Prof. dr., paul.dendale@jessazh.be

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HeartHab-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on HeartHab application intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe