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)
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change of total physical exercise: the Godin-Shepherd Leisure Time Physical Activity Questionnaire.
研究概览
简要总结
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.
详细描述
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/).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
App group
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.
干预措施: App group (Device)
Nursing telephone advice (NTA) group
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.
干预措施: Nursing telephone advice (NTA) group (Device)
结局指标
主要结局
Change of total physical exercise: the Godin-Shepherd Leisure Time Physical Activity Questionnaire.
时间窗: 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
次要结局
- 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)
- Hospitalization frequency(3 months)
- change of body weight(baseline, 3 months)
- change in LDL cholesterol(baseline, 3 months)
- Change of Quality of Life:ED-5D(baseline, 3 months)
- Change in HDL cholestero(baseline, 3 months)
研究者
Dr Eliza Wong
Principal investigator
The Hong Kong Polytechnic University