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

Coronary Artery Disease Clinical Trial

— HeartHab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668757
• Other study ID #: HeartHab-001
• Status: Completed
• Phase: N/A
• First received: January 27, 2016
• Last updated: February 26, 2018
• Start date: March 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on motivation	By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour	week 6
Secondary	Usability of the HeartHab application	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