A Randomized Controlled Trial of the Effectiveness of a Home-based Interactive E-health Educational Intervention for Middle-aged Cardiovascular Disease Adults in Improving Total Exercise, Adherence Rate, Exercise Efficacy and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 438
- 试验地点
- 2
- 主要终点
- Changes in total physical exercise (measured by The Godin-Shephard Leisure-Time Physical Activity Questionnaire)
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of death globally and e-health educational programs have been proved to be effective support to CVD clients. However, most e-health programs lack personalization and this seldom results in exercise behavioral change. Considering the advantages of e-health programs, as well as the widespread internet use and the rising trend of younger patients having CVD in Hong Kong, we conducted a Randomized Controlled Trial (RCT) to investigate the effectiveness of a home-based interactive e-health educational intervention versus usual care for middle aged cardiac vascular (CV) patients on their total physical exercise, exercise adherence and quality of life.
详细描述
Introduction:
Cardiovascular disease (CVD) is the leading cause of death globally and e-health educational programs have been proved to be effective support to CVD clients. However, most e-health programs lack personalization and this seldom results in exercise behavioral change. Considering the advantages of e-health programs, as well as the widespread internet use and the rising trend of younger patients having CVD in Hong Kong, we conducted a Randomized Controlled Trial (RCT) to investigate the effectiveness of a home-based interactive e-health educational intervention versus usual care on total physical exercise, exercise adherence and self efficacy, risk factor profile, psychological outcomes and quality of life for middle aged cardiac vascular (CV) patients.
Methods and analysis:
This is a prospective randomised clinical trial investigating effectiveness of a home-based interactive e-health educational intervention for middle-aged cardiovascular disease (CVD) adults in improving total exercise, adherence rate, exercise efficacy and outcomes. The hypothesis is that the middle-aged CVD patients (those who are 40-65 years old) would be more likely to adhere to exercise-based behavior that improves their total exercise, exercise adherence rate, cardiac risk profile , psychological outcomes and quality of life with the support of an interactive e-health educational intervention.
The RCT was conducted in two government cardiac clinics in Hong Kong. 438 eligible CV clients were randomized to either the control group (C) or the intervention group (I) using block randomization method. All participants received usual care while (I) additionally received the e-health educational intervention (eHEI) programme. This programme comprised of one-hour educational session, one telephone follow up and e-health link on self monitoring including record of health measures and physical exercise across 6 months. Data was collected at baseline, three months and six months intervals. The primary outcome was total physical exercise (GSLTPAQ). Secondary outcomes consisted of: exercise efficacy and adherence rate; CV risk profile; physical and psychological health outcomes (SF12 & HAD); biological parameter. Data was analyzed using generalized linear models.
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being an ethnic Chinese adult
- •who attends regular follow-up treatments for their CVD problems
- •aged 30-65
- •able to use and access the internet at home
- •willing to participate (with corresponding signed consent form)
排除标准
- •those with physical, mental, visual, or cognitive impairments as recorded in their health records
- •those who have contra-indications to walking.
结局指标
主要结局
Changes in total physical exercise (measured by The Godin-Shephard Leisure-Time Physical Activity Questionnaire)
时间窗: Baseline, 3 Months, 6 Months
Change in physical exercise is
次要结局
- Changes in exercise efficacy (measured by a validated scale. The scale consists of 9 items and responses are made on a 0-10 scale)(Baseline, 3 Months, 6 Months)
- Exercise adherence (two simple questions will be asked: how often do you do any physical activity per week? and What is the duration of the exercise on average?)(Baseline, 3 Months, 6 Months)
- Changes in anxiety and depression (Chinese version of the Hospital anxiety and depression scale)(Baseline, 3 Months, 6 Months)
- Changes in quality of Life (Chinese version of the health survey questionnaire (SF-12)(Baseline, 3 Months, 6 Months)
- Cardiac risk factor profile (Demographic data will be collected through questionnaire)(Baseline, 3 Months, 6 Months)
研究者
Wong Mi Ling Eliza
Assistant Professor
Chinese University of Hong Kong