Coronary Artery DiseaseNCT04858503
An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease
A study testing internet-based cardiac rehabilitation enhancement intervention in people with Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- internet-based cardiac rehabilitation enhancement intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2022to 31 Aug 2024
- 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
- ≥18 years of age
- living in the community,
- own a smartphone with internet access,
- communicable in Cantonese,
- type in Chinese or English,
- with a confirmed diagnosis of CAD.
Who cannot join
- enrolled to a structured centre-based or home-based cardiac rehabilitation program, (2) psychiatric problems,
- impaired cognitive functioning (i.e. Abbreviated Mental Test ≤6), and
- terminal disease with life expectancy < 1 year.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The School of Nursing
Hong Kong
Polly Li, Dr, 852-3917-6686, pwcli@hku.hk
About this study
Official title: An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease: A Mixed-method Study
This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.
Read the detailed description
This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.
Cardiovascular disease, a highly prevalent morbidity, is the number one cause of death worldwide and has become a significant public health concern. The majority of these deaths are attributed to an acute manifestation of coronary artery disease (CAD), defined as a narrowing of the coronary arteries that causes insufficient myocardial blood flow. CAD has reached an unequivocal pandemic status globally and locally. CAD imposes not only significant physical and psychosocial burdens on patients, but also enormous service demands on healthcare systems.As a chronic condition, CAD requires patients to practice persistent self-care in a long-term manner for successful disease management. Self-care is considered fundamental to the prevention and management of chronic diseases. Yet, a significant proportion of the CAD population is still engaging in full-time employment, their time availability restricts them to participate in traditional health promotional activities. According to recent systematic reviews, substantial evidence has accumulated to support the positive effects of internet-delivered interventions. Therefore, an internet-based approach with self-care cardiac rehabilitation enhancement may be ab better method of engaging patients in the learning process and arousing their inherent capacities to maintain behavioral modifications. This mixed-method study consists of a two-arm randomized controlled trial and an exploratory qualitative study. For the randomized controlled trial plans to recruit 268 adults from Queen Mary Hospital and Care for Your Heart. Eligible participants will be CAD patients who aged 18 above, living in the community, owning a smartphone with internet access, communicable in Cantonese and able to type in Chinese or English. The participants will be randomly allocated to the intervention or control group to receive i-CARE or usual care, respectively. The study hypotheizes that the CAD patients who receive the i-CARE intervention will report better changes in self-care behaviours, blood pressure, cholesterols, waist-to-height ratio, functional status and HRQoL at 3 and 6 months after the intervention, than those who receive usual care and that the CAD patients who receive the i-CARE intervention will report fewer cardiovascular event rates and mortality at 6 months after the intervention, than those who receive usual care. The findings will advance our knowledge of the empirical effects of internet-based cardiac rehabilitation programme on CAD patients.
- Conditions
- Coronary Artery Disease
- Being tested
- internet-based cardiac rehabilitation enhancement intervention
- Keywords
- Self-care, Model of care, Mobile app, Empowerment, Nurse-led, Disease Management, Risk factor control
- Medical subject headings
- Coronary Artery Disease, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based cardiac rehabilitation enhancement interventionOther
Participants in the intervention group will receive a 12-week i-CARE intervention, which will be designed to cover the core elements of CAD self-care: self-care maintenance, self-care monitoring and self-care management. The intervention will comprise: 1) a single individualized face-to-face session and 2) an internet-based intervention through a mobile application. Various behaviour change techniques will be used to increase the self-efficacy of CAD patients in enacting self-care behaviours.
| Study group | Role | What they receive |
|---|---|---|
| internet-based cardiac rehabilitation enhancement intervention | Experimental | internet-based cardiac rehabilitation enhancement intervention Receives: Other: internet-based cardiac rehabilitation enhancement intervention |
| conventional cares as arranged by hospital or community centers | No intervention | Participants will receive conventional cares as arranged by hospital or community centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care behaviour
the Chinese version of Self-Care of Coronary Heart Disease Inventory (SC-CHDI). This self-reported SC-CHDI (22 items) measures self-care maintenance, self-care management and self-care confidence on a four-point response scale. Each subscale score is transformed to 100 points, with higher scores indicate better self-care for that attribute.
Measured: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Secondary outcomes (6)
Biomarkers: lipid profile
POCT
Measured: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Physiological: blood pressure
Measure both systolic and diastolic blood pressure
Measured: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Anthropometric: waist-to-height ratio
Measure waist-to-height ratio
Measured: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Clinical: Cardiovascular event rates and mortality
the admissions, cardiovascular event rates and mortality data will be retrieved
Measured: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Self-reported health outcomes: functional status
The functional status will be measured with the Chinese version of Seattle Angina Questionnaire. This 19-item questionnaire consists of five subscales, including physical limitation, angina stability, angina frequency, treatment satisfaction and the disease perception. The respondents have to rate on a 1 to 5 or 6 sequentially coded status. The subscale scores are transformed to a scale of 0 to 100, with higher scores indicate higher level of functioning/ satisfaction and fewer limitations.
Measured: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Health-related Quality of life (HRQoL)
The Chinese version of MacNew will be used to measure disease-specific HRQoL.22 It consists of 27 items measuring HRQoL in three domains (physical, emotional and social). Each item is rated on a 1-7 scale, and a global score is calculated by summing the item scores, a higher score represents better HRQoL.
Measured: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Apr 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Polly Wai-Chi Li, The University of Hong Kong
- Investigators
- Polly Li, Dr, Principal investigator, The University of Hong Kong, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858503
- Sponsor's protocol ID
- NTWC/REC/20139
- Status last verified
- Nov 2023
- First submitted
- 21 Apr 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease: A Mixed-method Study
- ClinicalTrials.gov ID
- NCT04858503
- Acronym / sponsor ID
- NTWC/REC/20139
- Conditions
- Coronary Artery Disease
- Keywords
- Self-care, Model of care, Mobile app, Empowerment, Nurse-led, Disease Management, Risk factor control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 26 Apr 2021 (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.
This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.
Detailed description
This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.
Cardiovascular disease, a highly prevalent morbidity, is the number one cause of death worldwide and has become a significant public health concern. The majority of these deaths are attributed to an acute manifestation of coronary artery disease (CAD), defined as a narrowing of the coronary arteries that causes insufficient myocardial blood flow. CAD has reached an unequivocal pandemic status globally and locally. CAD imposes not only significant physical and psychosocial burdens on patients, but also enormous service demands on healthcare systems.As a chronic condition, CAD requires patients to practice persistent self-care in a long-term manner for successful disease management. Self-care is considered fundamental to the prevention and management of chronic diseases. Yet, a significant proportion of the CAD population is still engaging in full-time employment, their time availability restricts them to participate in traditional health promotional activities. According to recent systematic reviews, substantial evidence has accumulated to support the positive effects of internet-delivered interventions. Therefore, an internet-based approach with self-care cardiac rehabilitation enhancement may be ab better method of engaging patients in the learning process and arousing their inherent capacities to maintain behavioral modifications. This mixed-method study consists of a two-arm randomized controlled trial and an exploratory qualitative study. For the randomized controlled trial plans to recruit 268 adults from Queen Mary Hospital and Care for Your Heart. Eligible participants will be CAD patients who aged 18 above, living in the community, owning a smartphone with internet access, communicable in Cantonese and able to type in Chinese or English. The participants will be randomly allocated to the intervention or control group to receive i-CARE or usual care, respectively. The study hypotheizes that the CAD patients who receive the i-CARE intervention will report better changes in self-care behaviours, blood pressure, cholesterols, waist-to-height ratio, functional status and HRQoL at 3 and 6 months after the intervention, than those who receive usual care and that the CAD patients who receive the i-CARE intervention will report fewer cardiovascular event rates and mortality at 6 months after the intervention, than those who receive usual care. The findings will advance our knowledge of the empirical effects of internet-based cardiac rehabilitation programme on CAD patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internet-based cardiac rehabilitation enhancement intervention | Experimental | Other: internet-based cardiac rehabilitation enhancement interventioninternet-based cardiac rehabilitation enhancement intervention |
| conventional cares as arranged by hospital or community centers | No intervention | –Participants will receive conventional cares as arranged by hospital or community centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age
- living in the community,
- own a smartphone with internet access,
- communicable in Cantonese,
- type in Chinese or English,
Key exclusion criteria (3 listed)
- enrolled to a structured centre-based or home-based cardiac rehabilitation program, (2) psychiatric problems,
- impaired cognitive functioning (i.e. Abbreviated Mental Test ≤6), and
- terminal disease with life expectancy < 1 year.
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 |
|---|---|---|
| internet-based cardiac rehabilitation enhancement interventionParticipants in the intervention group will receive a 12-week i-CARE intervention, which will be designed to cover the core elements of CAD self-care: self-care maintenance, self-care monitoring and self-care management. The intervention will comprise: 1) a single individualized face-to-face session and 2) an internet-based intervention through a mobile application. Various behaviour change techniques will be used to increase the self-efficacy of CAD patients in enacting self-care behaviours. | Other | internet-based cardiac rehabilitation enhancement intervention |
Primary outcome
Self-care behaviour
Time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
the Chinese version of Self-Care of Coronary Heart Disease Inventory (SC-CHDI). This self-reported SC-CHDI (22 items) measures self-care maintenance, self-care management and self-care confidence on a four-point response scale. Each subscale score is transformed to 100 points, with higher scores indicate better self-care for that attribute.
6 secondary outcomes
Biomarkers: lipid profile
Time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Physiological: blood pressure
Time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Anthropometric: waist-to-height ratio
Time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Clinical: Cardiovascular event rates and mortality
Time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Self-reported health outcomes: functional status
Time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Health-related Quality of life (HRQoL)
Time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
Polly Li, Dr principal investigator
The University of Hong Kong, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based cardiac rehabilitation enhancement intervention in people with Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Polly Li, Dr (852-39176686, pwcli@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-care behaviour (time frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2023.