Effectiveness of the Nurse-led Support Programme Using a Mobile Application Versus Telephone Advice on Patients at Risk of Coronary Heart Disease - a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change of Self-efficacy and self-management behaviour
研究概览
简要总结
Topic: Effectiveness of the nurse-led support programme using a mobile application versus telephone advice on patients at risk of coronary heart disease - a randomized controlled trial
Aims: The study aims to compare the effects of a nurse-led support programme using a mobile application versus telephone advice on patients at risk of coronary heart disease who have been discharged from the emergency department (ED).
Methods: A multi-centre, single-blinded, randomized controlled trial will be conducted. 80 patients diagnosed as being at risk of CHD, able to use a smart phone, and who have been discharged from the ED will be randomized into the App Support Programme (ASP) group or the Telephone Support (TS) group. All participants will receive standard medical and nursing care on discharge. The ASP group will receive an app whereas the TS group will receive telephone support provided by the nurse for 20 minutes bi-weekly.
The self-developed mobile app will support clients in managing their health problems and lifestyle. It is comprised of: (1) a knowledge health platform, (2) a membership area for individual health measures and exercise records, (3) a Chest Pain - Things to Do List, and (4) an individual reminder and measure feedback system.
Health outcomes will be collected at baseline (T0), 1 month (T1), 3 months (T2). The primary outcome is Self-efficacy and self-management behavior. Secondary outcomes are: (i) ED and hospitalization frequency; (ii) Physiological health profile and cardiovascular functional endurance; (3) total amount of exercise; (4) perceived stress level; (5) health literacy; and (6) quality of life.
Data analysis: A Generalized Estimating Equations model will be used to assess differential changes in all outcome variables.
详细描述
Aims and Hypotheses to be Tested:
This study compares the effects of a nurse-led support programme - an app support programme (ASP) - with telephone support (TS) for patients discharged from the ED who are at risk of developing CHD. We hypothesize that:
Within 3 months, when compared with the TS group clients, clients who participate in the ASP will have:
Primary outcome: Better self-efficacy and self-management behaviour
Secondary outcomes:
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
- Single (Participant)
盲法说明
Randomization will be 1:1 to each treatment arm and will be stratified by the center. Block randomization with varying block sizes will be used to recruit equal numbers to each arm. A computer-generated randomizer will be used to generate the random allocation list. A statistician (DL) from the research team who is not involved in recruiting patients or collecting data will perform the randomization. Each eligible subject will be assigned a number generated by the computer. Subjects will be randomly allocated to different groups according to their number. In this study, the statisticians, outcome assessors, and research assistants assigned to perform data inputting will be blinded to the allocation sequence. Given the type of intervention, however, the intervention will be unmarked to the participants and the research nurse performing the intervention.
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
- •Chinese adults with a medical diagnosis of at-risk CHD disorders, including those with angina but no change in ST elevation on ECG and an acceptable troponin level 4 and those discharged from an ED; or those have at least two CHD risk factors : i) current regular smoker, ii) over 50 years of age; iii) has a medical diagnosis of diabetes or hypertension; iv) has a family history of ischaemic heart disease or hyperlipaedmia ;v) has hyperlipidaemia or is regularly taking drugs for hyperlipidaemia; vi) is obese (BMI>25); vii) has had a Percutaneous Coronary Intervention performed; and viii) was diagnosed with stable angina and prescribed with TNG drugs
- •Those able to perform a brisk walking exercise and who have passed the 3-minute walking test
- •Those who possess a smart phone and are able to use it.
排除标准
- •Those with physical, mental, visual, or cognitive impairments for which they are undergoing regular medical follow-ups and treatment
- •Those with musculoskeletal disorders or other disabling diseases that may limit the practice of any walking exercise.
结局指标
主要结局
Change of Self-efficacy and self-management behaviour
时间窗: Baseline, 3 months
Self-efficacy and self-management behaviour can be reflected by a total sum of score of a subscale of Self-efficacy in illness management (six items) and communication with healthcare professionals (three items) of the Self-Management Behaviour Questionnaire
次要结局
- Change of perceived stress scale (PSS-10)(Baseline, 3 months)
- Change of cardiovascular endurance test(Baseline, 3 months)
- Satisfactory level of the programme(3 months)
- Chest pain frequency(3 months)
- Blood pressure(3 months)
- Change of total physical exercise(Baseline, 3 months)
- Change of Health literacy(Baseline, 3 months)
- Change of Quality of Life:ED-5D(Baseline, 3 months)
- Hospitalization frequency(3 months)
研究者
Dr Eliza Wong
Assistant Professor
The Hong Kong Polytechnic University