Coronary Heart DiseaseNCT04968067
A Programme Using a Mobile Application Versus Phone Advice on Patients at Risk of Coronary Heart Disease - A RCT
A study testing App group and Nursing telephone advice (NTA) group in people with Coronary Heart Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
It aims to compare the effects of a professional -led support programme using a mobile application versus telephone advice on clients at risk of coronary heart disease. A multi-centre, single-blinded, randomized controlled trial will be conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- App group and Nursing telephone advice (NTA) group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2021to 3 Jun 2023
- 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
The study's subject inclusion criteria will be:
- Chinese adults with coronary cardiac risk factors (at least two from iv );
- those able to perform a brisk walking exercise; and
- those who possess a smart phone and are able to use it.
- Coronary heart disease risk factors:
- current regular smoker,
- over 50 years of age;
- has a medical diagnosis of diabetes or hypertension;
- has a family history of ischaemic heart disease or hyperlipaemia ;
- has hyperlipidaemia or is regularly taking drugs for hyperlipidaemia;
- is obese (BMI>25);
- has had a Percutaneous Coronary Intervention performed;
- was diagnosed with stable angina and prescribed with Trinitroglycerin (TNG) drugs.
The exclusion criteria will be those :
- with mental, visual, hearing, or cognitive impairments as a result of which they are unable to perform a brisk walking exercise or communicate using a smart phone;
- on a waiting list for cardiac angiography within 6 months, and
- has medical diagnosis of unstable angina.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Professional-led Support Programme Using a Mobile Application Versus Phone Advice on Patients at Risk of Coronary Heart Disease - A Randomized Controlled Trial (Phase 2)
It aims to compare the effects of a professional -led support programme using a mobile application versus telephone advice on clients at risk of coronary heart disease. A multi-centre, single-blinded, randomized controlled trial will be conducted. 168 Clients who are at risk of coronary heart disease (CHD), able to use a smart phone will be randomized into the App Support group (App group) or the Nursing Telephone advice (NTA) group . All participants will receive same nursing educational briefing related to CHD. The App Group will additional receive an app use to support their self care whereas the NTA group will receive nursing telephone advice for 20 minutes monthly.
Health outcomes will be collected at baseline (T0), 1 months (T1), 3 months (T2). Data analysis will be conducted using a Generalized Estimating Equations model to assess differential changes in all outcome variables.
Read the detailed description
The aim of this study is to test the effects of a professional-led support programme for clients who are at risk of developing CHD on outcomes of total exercise, self-efficacy and self-management behavior, emergency department attendance and hospitalizations, CHD risk factor profile, and quality of life.
Over 3 months, the investigators will examine the effect on the App group as compared to the NTA group and the control group of: Total amount of exercise (primary outcome) and secondary outcomes:1) Self-efficacy and self-management behavior; 2)Emergency department attendance and hospitalization frequency;3) CHD risk factor profile (smoking, blood pressure, body mass index, blood lipid level);4) Cardiovascular functional endurance;5)Perceived stress ; and 6) Quality of life.
A prospective multi-Centre, parallel, randomized controlled trial (RCT) with two arms - an app support programme (App) group vs a Nursing Telephone advice (NTA) group and a control group - will be adopted. The RCT method follow CONSORT 2010 guideline. 168 subjects will be required (n=84 each group). Subject recruitment will likely take about 14 months.
Intervention protocol: 168 Clients who are at risk of coronary heart disease (CHD), able to use a smart phone will be randomized into the App Support group (App group) or the Nursing Telephone advice (NTA) group. All eligible participants will receive same nursing educational briefing related to CHD. The App Group will additionally receive an app use to support their self -care whereas the NTA group will receive a leaflet and a monthly nursing telephone advice ( about 20 minutes per call. The duration of intervention will be about 3 months. Health outcomes will be collected by research assistant at baseline (T0), 1 months (T1), 3 months (T2) at the community Centre or research Centre. Data analysis will be conducted using SPSS and a Generalized Estimating Equations model to assess differential changes in all outcome variables. All the tests will be two-sided and a p-value of <0.05 will be considered statistically significant.
Ethical approval and permission will be sought from the study university and the selected community centres. RCT registration has been obtained from the ClinicalTrials.gov Protocol Registration system (https://clinicaltrials.gov/).
- Conditions
- Coronary Heart Disease
- Being tested
- App group, Nursing telephone advice (NTA) group
- Keywords
- e-health, nursing telephone advice, exercise, risk factors
- Medical subject headings
- Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App groupDevice
In addition to the usual care, the participant will receive a health talk related to CHD care, a CHD app and a briefing from a trained research nurse (A). The app provides features such as structured e-educational contents and supportive features such as knowledge platform and member area.
Nursing telephone advice (NTA) groupDevice
All subjects will continue their usual care with prescribed medical treatments and follow-ups if any. By appointment, a trained nurse will provide a health talk related to the CHD care. In addition to the above usual care, three monthly 20-minute telephone follow-ups supplemented by take home leaflet will be provided by a trained research nurse for up to 3 months. Patients can ask about their related health problems, if any. The team has set up a telephone advice guide to support the research nurse in giving phone advice and text messages. .In summary, all two groups will receive from a nurse similar educational content as that related to their CHD and care. The only difference will be the re-enforcement and continual support provided through an app, telephone nursing advice and leaflet.
| Study group | Role | What they receive |
|---|---|---|
| App group | Experimental | In addition to the usual care, the participant will receive a health talk , a CHD app and a briefing from a trained research nurse (A). The app provides features such as structured e-educational contents and supportive features such as knowledge platform and member area. Receives: Device: App group |
| Nursing telephone advice (NTA) group | Active comparator | In addition to the above usual care, the participant will receive a health talk , three monthly 20-minute telephone follow-ups supplemented by take home leaflet will be provided by a trained research nurse for up to 3 months. Patients can ask about their related health problems, if any. The team has set up a telephone advice guide to support the research nurse in giving phone advice and text messages. Receives: Device: Nursing telephone advice (NTA) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total physical exercise: the Godin-Shepherd Leisure Time Physical Activity Questionnaire.
This scale measures the frequency, duration the respondent has performed strenuous, moderate and mild exercise outside of their work duties. The total weekly leisure activity is calculated in arbitrary units as a sum of the products of the separate components
Measured: baseline, 3 months
Secondary outcomes (10)
Change of Self-efficacy in illness management
Six items of Self-efficacy in illness management from The Chinese Self-Management Behaviour Questionnaire was used. It was originally developed by Lorig, and the Chinese language version was translated and validated by Siu et al. in Hong Kong. A final subtotal sum of score could be calculated to assess their self efficacy level.
Measured: baseline, 3 months
Change of blood pressure
systolic and distolic pressure will be collected by research assistant
Measured: baseline, 3 months
Change of cardiovascular endurance test
Three-minute step test aims to test the client's cardiovascular functional endurance after exercise across the age span and gender. A participant step on and off of a 12-inch high bench/ or stair for 3 minutes. Their pulse is then taken while the participant remains standing. Compare the heart rate with the table according to the age and gender to determine the fitness within a range of 7 scores from excellent to good, above average, average, below average, poor and very poor.
Measured: baseline, 3 months
Change of total physical exercise
This outcome will be measured using the Godin-Shepherd Leisure Time Physical Activity Questionnaire. This scale measures how often per week and how long per session the respondent has performed strenuous, moderate and mild exercise outside of their work duties.
Measured: baseline, 3 months
Change of perceived stress scale (PSS-10)
10 self-reported items are used to measure the degree to which situation in a person's life are considered stressful, as well as the current levels of stress experienced in the last month. The summative scores range from 0 to 40, with higher scores indicating higher stress levels. These scores have been used previously to assess the experienced level of stress as an outcome measure and have good psychometric properties in cardiac patients.
Measured: baseline, 3 months
Change of Quality of Life:ED-5D
The ED-5D is a generic instrument used to measure the quality of life in patients with cardiovascular disease in Chinese and other populations. These scale is divided into 5 parts: mobility, self-care, usual activities, pain/discomfort and anxiety/ depression. Participants are asked to respond to the items using the following options: no problem, moderate problems, and extreme problems. The 5 items will also be ranked on a visual analogue scale (VAS) with a range with points from 0 (worst possible health) to 100 (best possible health) to assess the patient's health. The ED-5D was found to be satisfactorily valid and reliable in many populations, including CHD patients.
Measured: baseline, 3 months
Hospitalization frequency
frequency of hospitalization will be asked.
Measured: 3 months
change of body weight
body weight will be measured by RA
Measured: baseline, 3 months
change in LDL cholesterol
Blood samples for measuring LDL cholesterol will be taken by using a finger stick using auto-analysed and the participants are asked to have 8 hours fasting.
Measured: baseline, 3 months
Change in HDL cholestero
Blood samples for measuring HDL cholesterol will be taken by using a finger stick using auto-analysed and the participants are asked to have 8 hours fasting.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion3 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will employ a prospective randomized controlled trial (RCT) with two arms, namely, the App group, NTA (nursing telephone advice) group. This design is guided by the CONSORT checklist
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah College
- Responsible party
- Principal investigator, Dr Eliza Wong, The Hong Kong Polytechnic University
- Investigators
- Eliza ML wong, PhD, Principal investigator, Tung Wah College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968067
- Sponsor's protocol ID
- HSEARS20201218002
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Professional-led Support Programme Using a Mobile Application Versus Phone Advice on Patients at Risk of Coronary Heart Disease - A Randomized Controlled Trial (Phase 2)
- ClinicalTrials.gov ID
- NCT04968067
- Acronym / sponsor ID
- HSEARS20201218002
- Conditions
- Coronary Heart Disease
- Keywords
- e-health, nursing telephone advice, exercise, risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Tung Wah College
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 3 Jun 2023 (estimated)
- First posted
- 20 Jul 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.
It aims to compare the effects of a professional -led support programme using a mobile application versus telephone advice on clients at risk of coronary heart disease. A multi-centre, single-blinded, randomized controlled trial will be conducted. 168 Clients who are at risk of coronary heart disease (CHD), able to use a smart phone will be randomized into the App Support group (App group) or the Nursing Telephone advice (NTA) group . All participants will receive same nursing educational briefing related to CHD. The App Group will additional receive an app use to support their self care whereas the NTA group will receive nursing telephone advice for 20 minutes monthly.
Health outcomes will be collected at baseline (T0), 1 months (T1), 3 months (T2). Data analysis will be conducted using a Generalized Estimating Equations model to assess differential changes in all outcome variables.
Detailed description
The aim of this study is to test the effects of a professional-led support programme for clients who are at risk of developing CHD on outcomes of total exercise, self-efficacy and self-management behavior, emergency department attendance and hospitalizations, CHD risk factor profile, and quality of life.
Over 3 months, the investigators will examine the effect on the App group as compared to the NTA group and the control group of: Total amount of exercise (primary outcome) and secondary outcomes:1) Self-efficacy and self-management behavior; 2)Emergency department attendance and hospitalization frequency;3) CHD risk factor profile (smoking, blood pressure, body mass index, blood lipid level);4) Cardiovascular functional endurance;5)Perceived stress ; and 6) Quality of life.
A prospective multi-Centre, parallel, randomized controlled trial (RCT) with two arms - an app support programme (App) group vs a Nursing Telephone advice (NTA) group and a control group - will be adopted. The RCT method follow CONSORT 2010 guideline. 168 subjects will be required (n=84 each group). Subject recruitment will likely take about 14 months.
Intervention protocol: 168 Clients who are at risk of coronary heart disease (CHD), able to use a smart phone will be randomized into the App Support group (App group) or the Nursing Telephone advice (NTA) group. All eligible participants will receive same nursing educational briefing related to CHD. The App Group will additionally receive an app use to support their self -care whereas the NTA group will receive a leaflet and a monthly nursing telephone advice ( about 20 minutes per call. The duration of intervention will be about 3 months. Health outcomes will be collected by research assistant at baseline (T0), 1 months (T1), 3 months (T2) at the community Centre or research Centre. Data analysis will be conducted using SPSS and a Generalized Estimating Equations model to assess differential changes in all outcome variables. All the tests will be two-sided and a p-value of <0.05 will be considered statistically significant.
Ethical approval and permission will be sought from the study university and the selected community centres. RCT registration has been obtained from the ClinicalTrials.gov Protocol Registration system (https://clinicaltrials.gov/).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will employ a prospective randomized controlled trial (RCT) with two arms, namely, the App group, NTA (nursing telephone advice) group. This design is guided by the CONSORT checklist
| Arm | Type | Receives |
|---|---|---|
| App group | Experimental | Device: App groupIn addition to the usual care, the participant will receive a health talk , a CHD app and a briefing from a trained research nurse (A). The app provides features such as structured e-educational contents and supportive features such as knowledge platform and member area. |
| Nursing telephone advice (NTA) group | Active comparator | Device: Nursing telephone advice (NTA) groupIn addition to the above usual care, the participant will receive a health talk , three monthly 20-minute telephone follow-ups supplemented by take home leaflet will be provided by a trained research nurse for up to 3 months. Patients can ask about their related health problems, if any. The team has set up a telephone advice guide to support the research nurse in giving phone advice and text messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| App groupIn addition to the usual care, the participant will receive a health talk related to CHD care, a CHD app and a briefing from a trained research nurse (A). The app provides features such as structured e-educational contents and supportive features such as knowledge platform and member area. | Device | App group |
| Nursing telephone advice (NTA) groupAll subjects will continue their usual care with prescribed medical treatments and follow-ups if any. By appointment, a trained nurse will provide a health talk related to the CHD care. In addition to the above usual care, three monthly 20-minute telephone follow-ups supplemented by take home leaflet will be provided by a trained research nurse for up to 3 months. Patients can ask about their related health problems, if any. The team has set up a telephone advice guide to support the research nurse in giving phone advice and text messages. .In summary, all two groups will receive from a nurse similar educational content as that related to their CHD and care. The only difference will be the re-enforcement and continual support provided through an app, telephone nursing advice and leaflet. | Device | Nursing telephone advice (NTA) group |
Primary outcome
Change of total physical exercise: the Godin-Shepherd Leisure Time Physical Activity Questionnaire.
Time frame: baseline, 3 months
This scale measures the frequency, duration the respondent has performed strenuous, moderate and mild exercise outside of their work duties. The total weekly leisure activity is calculated in arbitrary units as a sum of the products of the separate components
10 secondary outcomes
Change of Self-efficacy in illness management
Time frame: baseline, 3 months
Change of blood pressure
Time frame: baseline, 3 months
Change of cardiovascular endurance test
Time frame: baseline, 3 months
Change of total physical exercise
Time frame: baseline, 3 months
Change of perceived stress scale (PSS-10)
Time frame: baseline, 3 months
Change of Quality of Life:ED-5D
Time frame: baseline, 3 months
Hospitalization frequency
Time frame: 3 months
change of body weight
Time frame: baseline, 3 months
change in LDL cholesterol
Time frame: baseline, 3 months
Change in HDL cholestero
Time frame: baseline, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Eliza ML wong, PhD principal investigator
Tung Wah College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App group and Nursing telephone advice (NTA) group in people with Coronary Heart Disease, run by The Hong Kong Polytechnic University 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?
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 5 Aug 2021. 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 Doris YP Leung, PhD (27666423, doris.yp.leung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of total physical exercise: the Godin-Shepherd Leisure Time Physical Activity Questionnaire. (time frame: baseline, 3 months). 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 5 Aug 2021.