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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02668757
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
prof. dr. Paul Dendale, Hasselt University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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 : March 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Impact on motivation [ Time Frame: 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 [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668757


Locations
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Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Paul Dendale, Prof. dr. paul.dendale@jessazh.be

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Responsible Party: prof. dr. Paul Dendale, prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT02668757     History of Changes
Other Study ID Numbers: HeartHab-001
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases