A Programme Using a Mobile Application Versus Phone Advice on Patients at Risk of Coronary Heart Disease - A RCT
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)
1 other identifier
interventional
168
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2023
CompletedAugust 5, 2021
July 1, 2021
1.2 years
July 13, 2021
July 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
baseline, 3 months
Secondary Outcomes (10)
Change of Self-efficacy in illness management
baseline, 3 months
Change of blood pressure
baseline, 3 months
Change of cardiovascular endurance test
baseline, 3 months
Change of total physical exercise
baseline, 3 months
Change of perceived stress scale (PSS-10)
baseline, 3 months
- +5 more secondary outcomes
Study Arms (2)
App group
EXPERIMENTALIn 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 COMPARATORIn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hong Kong Polytechnic Universitylead
- Tung Wah Collegecollaborator
Study Sites (1)
Wan chai Methodist Centre for the Seniors
Hong Kong, 00, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eliza ML wong, PhD
Tung Wah College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- To minimize subject contamination, the different groups will be assigned different follow-up dates. The research assistants who are responsible for collecting data will be blinded to the group allocations. To ensure allocation concealment, each computer generated sequence will be put in a sequentially numbered, opaque sealed envelope. The envelope will be opened by RA1 after the participant has completed the baseline questionnaire.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 20, 2021
Study Start
August 1, 2021
Primary Completion
October 30, 2022
Study Completion
June 3, 2023
Last Updated
August 5, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share