Coronary Artery DiseaseNCT03102671
Effectiveness of the HeartHab Application on Exercise Capacity in Patients With Coronary Artery Disease
A study of Coronary Artery Disease, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HeartHab: a Prospective Cross-over Trial Investigating the Effectiveness of an App Based Telerehabilitation Program on Exercise Capacity, Lifestyle and Risk Factors in Patients With Coronary Artery Disease
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.
Read the detailed description
Study design and population This study is a prospective double-arm, non-pragmatic, cross-over, randomized controlled trial. Approximately 30 subjects will be selected retrospectively from the cardiology database of the Jessa Hospital Hasselt. Subjects who do not violate any of the predefined exclusion criteria and have provided informed consent will be randomly assigned in a 1:1 ratio to the treatment strategies (AB sequence or BA sequence).
After two months, each individual will be switched to the other treatment strategy.
Measurements At baseline, after two months (+14 days) and after four months (+14 days), a clinical assessment, medical history, current medication therapy, fasting blood sample, maximal cardiopulmonary exercise test, pulmonary function and three completed questionnaires (HeartQol, IPAQ and EQ-5D) will be collected of all patients. A fourth questionnaire will be completed by all the patients, focusing on the usability of the HeartHab-application.
Statistical analysis Data analysis will be performed using SPSS version 22 (SPSS Inc, Chicago, IL, USA) according to the intention-to-treat principle by assigned treatment group. Nonparametric alternatives will be used for parametric statistics in case assumptions for the latter are violated. The Shapiro-Wilk test will be used to assess normality. Paired t tests (parametric) or Wilcoxon signed rank tests (nonparametric) will be used for within-group analysis; independent t tests (parametric) or Mann-Whitney U tests (nonparametric) for between-group analysis. Chi-square tests will be used in case of categorical variables; Fisher's exact tests will be used when expected frequencies are small. The significance level for tests is 2-sided α=.05.
The cost-effectiveness evaluation will be conducted from a society and patient perspective, taking into account both intervention and health care resource costs. As the majority of patients will be retired, productivity losses due to illness-related absence from the workplace will not be taken into account.
Health care costs will be the aggregated costs of hospital admissions for cardiovascular reasons and also specialist visits and associated diagnostics. The cardiovascular rehospitalizations' related costs will be derived from invoices retrieved from the recruiting hospitals' financial departments. INAMI/RIZIV's nomenclature-based tariffs will define specialist visits and diagnostics denominations.
Quality adjusted life years (QALYs) will be used as a generic measure of effectiveness. Estimates of QALYs will be derived from the EQ-5D questionnaire. The EQ-5D scores will be converted to utility scores. The utility estimates will be converted to adjusted mean QALYs by calculating the area under the curve (AUC) utility estimates for all time intervals for each patient, weighted by the length of follow-up at that time interval. The change from baseline utility (adjusted differential incremental QALYs) will then be calculated, using the multiple regression model to control for baseline utility differences.
The incremental cost-effectiveness ratio (ICER) will be calculated (ICER¼(Cost intervention group - Cost control group)/(Effectiveness intervention group - Effectiveness control group)) to compare costs and outcomes (effectiveness) across both treatment groups. The incremental cost will be determined by the difference in total average cost per patient between the intervention group and control group. The incremental effectiveness will be estimated by the adjusted differential incremental QALYs.
- Conditions
- Coronary Artery Disease
- Being tested
- Use of HeartHab application followed by usual care, Usual care followed by the use of HeartHab application
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of HeartHab application followed by usual careOther
use of a mobile, app based multidisciplinary telerehabilitation program (2 months) followed by usual care (two months)
Usual care followed by the use of HeartHab applicationOther
Usual care (2 months) followed by the use of HeartHab application (two months)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Other: Use of HeartHab application followed by usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2peak
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
Measured: day1
Change in VO2peak
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
Measured: month 2 + 14 days
Change in VO2peak
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
Measured: month 4 + 14 days
Secondary outcomes (27)
Risk factor profile: physiological parameter
Blood pressure
Measured: day 1
Risk factor profile: physiological parameter
Diabetes
Measured: day 1
Risk factor profile: physiological parameter
Overweight
Measured: day 1
Risk factor profile: physiological parameter
Smoking
Measured: day 1
Risk factor profile: physiological parameter
Physical activity
Measured: day 1
Risk factor profile: physiological parameter
Blood pressure
Measured: month 2 + 14 days
Risk factor profile: physiological parameter
Diabetes
Measured: month 2 + 14 days
Risk factor profile: physiological parameter
Overweight
Measured: month 2 + 14 days
Risk factor profile: physiological parameter
Smoking
Measured: month 2 + 14 days
Risk factor profile: physiological parameter
Physical activity
Measured: month 2 + 14 days
Risk factor profile: physiological parameter
Blood pressure
Measured: month 4 + 14 days
Risk factor profile: physiological parameter
Diabetes
Measured: month 4 + 14 days
Risk factor profile: physiological parameter
Overweight
Measured: month 4 + 14 days
Risk factor profile: physiological parameter
Smoking
Measured: month 4 + 14 days
Risk factor profile: physiological parameter
Physical activity
Measured: month 4 + 14 days
Generic health status: questionnaire
EQ5D
Measured: day 1
Exercise capacity: questionnaire
IPAQ
Measured: day 1
Quality of life: questionnaire
Heart QoL
Measured: day 1
Generic health status: questionnaire
EQ5D
Measured: month 2 + 14 days
Exercise capacity: questionnaire
IPAQ
Measured: month 2 + 14 days
Quality of life: questionnaire
Heart QoL
Measured: month 2 + 14 days
Generic health status: questionnaire
EQ5D
Measured: month 4 + 14 days
Exercise capacity: questionnaire
IPAQ
Measured: month 4 + 14 days
Quality of life: questionnaire
Heart QoL
Measured: month 4 + 14 days
Cardiovascular events: clinical assessment
Collection of adverse events during follow up visit
Measured: day 1
Cardiovascular events: clinical assessment
Collection of adverse events during follow up visit
Measured: month 2 + 14 days
Cardiovascular events: clinical assessment
Collection of adverse events during follow up visit
Measured: month 4 + 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 Mar 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
- Investigators
- Paul Dendale, prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102671
- Sponsor's protocol ID
- HeartHab-002
- Status last verified
- Feb 2018
- First submitted
- 26 Mar 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30946021
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartHab: a Prospective Cross-over Trial Investigating the Effectiveness of an App Based Telerehabilitation Program on Exercise Capacity, Lifestyle and Risk Factors in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03102671
- Acronym / sponsor ID
- HeartHab-002
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design and population This study is a prospective double-arm, non-pragmatic, cross-over, randomized controlled trial. Approximately 30 subjects will be selected retrospectively from the cardiology database of the Jessa Hospital Hasselt. Subjects who do not violate any of the predefined exclusion criteria and have provided informed consent will be randomly assigned in a 1:1 ratio to the treatment strategies (AB sequence or BA sequence).
After two months, each individual will be switched to the other treatment strategy.
Measurements At baseline, after two months (+14 days) and after four months (+14 days), a clinical assessment, medical history, current medication therapy, fasting blood sample, maximal cardiopulmonary exercise test, pulmonary function and three completed questionnaires (HeartQol, IPAQ and EQ-5D) will be collected of all patients. A fourth questionnaire will be completed by all the patients, focusing on the usability of the HeartHab-application.
Statistical analysis Data analysis will be performed using SPSS version 22 (SPSS Inc, Chicago, IL, USA) according to the intention-to-treat principle by assigned treatment group. Nonparametric alternatives will be used for parametric statistics in case assumptions for the latter are violated. The Shapiro-Wilk test will be used to assess normality. Paired t tests (parametric) or Wilcoxon signed rank tests (nonparametric) will be used for within-group analysis; independent t tests (parametric) or Mann-Whitney U tests (nonparametric) for between-group analysis. Chi-square tests will be used in case of categorical variables; Fisher's exact tests will be used when expected frequencies are small. The significance level for tests is 2-sided α=.05.
The cost-effectiveness evaluation will be conducted from a society and patient perspective, taking into account both intervention and health care resource costs. As the majority of patients will be retired, productivity losses due to illness-related absence from the workplace will not be taken into account.
Health care costs will be the aggregated costs of hospital admissions for cardiovascular reasons and also specialist visits and associated diagnostics. The cardiovascular rehospitalizations' related costs will be derived from invoices retrieved from the recruiting hospitals' financial departments. INAMI/RIZIV's nomenclature-based tariffs will define specialist visits and diagnostics denominations.
Quality adjusted life years (QALYs) will be used as a generic measure of effectiveness. Estimates of QALYs will be derived from the EQ-5D questionnaire. The EQ-5D scores will be converted to utility scores. The utility estimates will be converted to adjusted mean QALYs by calculating the area under the curve (AUC) utility estimates for all time intervals for each patient, weighted by the length of follow-up at that time interval. The change from baseline utility (adjusted differential incremental QALYs) will then be calculated, using the multiple regression model to control for baseline utility differences.
The incremental cost-effectiveness ratio (ICER) will be calculated (ICER¼(Cost intervention group - Cost control group)/(Effectiveness intervention group - Effectiveness control group)) to compare costs and outcomes (effectiveness) across both treatment groups. The incremental cost will be determined by the difference in total average cost per patient between the intervention group and control group. The incremental effectiveness will be estimated by the adjusted differential incremental QALYs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB sequence | Experimental | Other: Usual care followed by the use of HeartHab applicationUsual 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. |
| BA sequence | Experimental | Other: Use of HeartHab application followed by usual careUse 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of HeartHab application followed by usual careuse of a mobile, app based multidisciplinary telerehabilitation program (2 months) followed by usual care (two months) | Other | BA sequence |
| Usual care followed by the use of HeartHab applicationUsual care (2 months) followed by the use of HeartHab application (two months) | Other | AB sequence |
Primary outcome
Change in VO2peak
Time frame: day1
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
Change in VO2peak
Time frame: month 2 + 14 days
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
Change in VO2peak
Time frame: month 4 + 14 days
Exercise capacity is defined as the peak oxygen uptake, measured by CPET (cardiopulmonary exercise test)
27 secondary outcomes
Risk factor profile: physiological parameter
Time frame: day 1
Risk factor profile: physiological parameter
Time frame: day 1
Risk factor profile: physiological parameter
Time frame: day 1
Risk factor profile: physiological parameter
Time frame: day 1
Risk factor profile: physiological parameter
Time frame: day 1
Risk factor profile: physiological parameter
Time frame: month 2 + 14 days
Risk factor profile: physiological parameter
Time frame: month 2 + 14 days
Risk factor profile: physiological parameter
Time frame: month 2 + 14 days
Risk factor profile: physiological parameter
Time frame: month 2 + 14 days
Risk factor profile: physiological parameter
Time frame: month 2 + 14 days
Risk factor profile: physiological parameter
Time frame: month 4 + 14 days
Risk factor profile: physiological parameter
Time frame: month 4 + 14 days
Risk factor profile: physiological parameter
Time frame: month 4 + 14 days
Risk factor profile: physiological parameter
Time frame: month 4 + 14 days
Risk factor profile: physiological parameter
Time frame: month 4 + 14 days
Generic health status: questionnaire
Time frame: day 1
Exercise capacity: questionnaire
Time frame: day 1
Quality of life: questionnaire
Time frame: day 1
Generic health status: questionnaire
Time frame: month 2 + 14 days
Exercise capacity: questionnaire
Time frame: month 2 + 14 days
Quality of life: questionnaire
Time frame: month 2 + 14 days
Generic health status: questionnaire
Time frame: month 4 + 14 days
Exercise capacity: questionnaire
Time frame: month 4 + 14 days
Quality of life: questionnaire
Time frame: month 4 + 14 days
Cardiovascular events: clinical assessment
Time frame: day 1
Cardiovascular events: clinical assessment
Time frame: month 2 + 14 days
Cardiovascular events: clinical assessment
Time frame: month 4 + 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Derived from this study: PubMed 30946021Sankaran 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dendale, prof. dr. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Coronary Artery Disease, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2peak (time frame: day1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.