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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HeartHab application intervention
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jessa Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HeartHab application arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2016
Last Updated
February 26, 2018
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT02668757
Brief Title
HeartHab, Can a Patient-tailored Application Support Coronary Artery Disease Patients During Rehabilitation?
Acronym
HeartHab
Official Title
Pilot Study, How the HeartHab Application Can Support Coronary Artery Disease Patients in Their Rehabilitation Program?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HeartHab application arm
Arm Type
Other
Arm Description
Patients in the HeartHab application arm will receive the mobile application during study period.
Intervention Type
Behavioral
Intervention Name(s)
HeartHab application intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Impact on motivation
Description
By means of a questionnaire and an interview, questions are asked about participants' motivation for a tour
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Usability of the HeartHab application
Description
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
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Dendale, Prof. dr.
Organizational Affiliation
paul.dendale@jessazh.be
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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