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

• Sponsor: Hasselt University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02668757
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 22
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Behavioral: HeartHab application intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Pilot Study, How the HeartHab Application Can Support Coronary Artery Disease Patients in Their Rehabilitation Program?
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Impact on motivation [week 6]

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

Secondary Outcome Measures

1. Usability of the HeartHab application [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessa Ziekenhuis	Hasselt		Belgium

Sponsors and Collaborators

• Hasselt University

Investigators

• Principal Investigator: Paul Dendale, Prof. dr., [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: prof. dr. Paul Dendale, prof. dr., Hasselt University
• ClinicalTrials.gov Identifier: NCT02668757
• Other Study ID Numbers: HeartHab-001
• First Posted: Jan 29, 2016
• Last Update Posted: Feb 28, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Feb 28, 2018