Effectiveness of the HeartHab Application on Exercise Capacity in Patients With Coronary Artery Disease

NCT03102671 | Completed

• 1 other identifier: HeartHab-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The recurrence of major cardiac events after infarction is very high, in some populations up to 20% in the first year. Optimal secondary prevention as organized in cardiac rehabilitation centers is effective in reducing both morbidity and mortality. However, many studies have shown that the participation and adherence rate in CR-programs is low in most European countries. Therefore, novel ways of delivering secondary prevention using information technology and self-monitoring are being explored. Hence, this study will investigate the effectiveness of a mobile, patient tailored, app based multidisciplinary telerehabilitation program (HeartHab app) in improving exercise capacity, lifestyle and risk factors in patients with coronary artery disease in a post-rehabilitation setting.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Change in VO2peak

  Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)

  day1

• Change in VO2peak

  Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)

  month 2 + 14 days

• Change in VO2peak

  Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)

  month 4 + 14 days

Secondary Outcomes (27)

• Risk factor profile: physiological parameter

  day 1

• Risk factor profile: physiological parameter

  day 1

• Risk factor profile: physiological parameter

  day 1

• Risk factor profile: physiological parameter

  day 1

• Risk factor profile: physiological parameter

  day 1

Study Arms (2)

AB sequence

EXPERIMENTAL

Usual care followed by use of HeartHab application: Treatment A comprises the usual care (i.e. one information session on the importance of medication adherence, risk factor control and healthy lifestyle), followed by telemonitoring during treatment B. The tele-intervention will consist of two months telerehabilitation and telecoaching concerning physical activity, healthy lifestyle and medication adherence.

Other: Usual care followed by the use of HeartHab application

BA sequence

EXPERIMENTAL

Use of HeartHab application followed by usual care: patients will be followed by telemonitoring during treatment B. The tele-intervention will consist of two months telerehabilitation and telecoaching concerning physical activity, healthy lifestyle and medication adherence, followed by treatment A comprises the usual care (i.e. one information session on the importance of medication adherence, risk factor control and healthy lifestyle)

Other: Use of HeartHab application followed by usual care

Interventions

Use of HeartHab application followed by usual care OTHER

use of a mobile, app based multidisciplinary telerehabilitation program (2 months) followed by usual care (two months)

BA sequence

Usual care followed by the use of HeartHab application OTHER

Usual care (2 months) followed by the use of HeartHab application (two months)

AB sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of coronary artery disease with or without intervention (PCI/CABG/conservative)
• History of a cardiac rehabilitation (CR) program
• Clinically stable without inducible ischemia or high risk ventricular arrhythmia, confirmed by the last available maximal ergospirometry test
• Age ≥18 years
• Willing and physically able to follow an app based telerehabilitation program and other study procedures in a four months follow-up period
• Evidence of a personally signed and dated informed consent, indicating that the subject (or legally-recognised representative) has been informed of all pertinent aspects of the study
• Possession of and/or able to use an Android smartphone
• Dutch speaking and understanding

You may not qualify if:

• Recent PCI or CABG procedure, and still included in a CR program
• Orthopedic, neurologic or any other pathologic condition which makes the patient physically unable to follow an app based telerehabilitation program
• Planned interventional procedure or surgery in the next four months
• Pregnant females
• Present cardiovascular complaints
• Participation in other cardiac rehabilitation program trials, focusing on exercise outcome
• Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than 4 months based on investigators judgement

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

Location

Related Publications (1)

• Sankaran S, Dendale P, Coninx K. Evaluating the Impact of the HeartHab App on Motivation, Physical Activity, Quality of Life, and Risk Factors of Coronary Artery Disease Patients: Multidisciplinary Crossover Study. JMIR Mhealth Uhealth. 2019 Apr 4;7(4):e10874. doi: 10.2196/10874.

  PMID: 30946021 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Paul Dendale, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 6, 2017
• Study Start: March 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

BE (1)