Impact of a Mobile Health Application in Improving Lifestyle and Therapeutic Adherence in Coronary Heart Disease: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in Frequency of food consumption
研究概览
简要总结
Cardiovascular diseases are the leading cause of death worldwide. In high-income countries, approximately seventy percent of cardiovascular diseases cases are attributable to modifiable risk factors, with metabolic risk factors (obesity, cholesterol) and tobacco use being the most closely associated.
Secondary prevention of coronary disease is considered essential, since it has contributed significantly to the reduction of morbidity and mortality, by facilitating the adoption and adherence to healthy behaviors, promoting an active lifestyle, and increasing adherence to pharmacological treatment.
Information and communication technologies have been increasingly incorporated into health care systems, including the innovative provision of Cardiac Rehabilitation through a mobile phone or m-health interventions. M-health technology can provide evidence-based guidance in an interactive format that is attractive, easy to use, and reduces healthcare costs.
The objective of this study is to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a web application of health, mobile Health, on lifestyle (diet, physical activity, and nicotine dependence) and therapeutic adherence in people with coronary heart disease.
The sample will consist of 200 participants, 100 in the intervention group and 100 in the usual care group that will be evaluated at the beginning and 3, 6, and 12 months after hospital discharge regarding sociodemographic, clinical, cardiovascular risk factors, lifestyle, and therapeutic adherence characteristics. The educational intervention, monitoring, and self-monitoring will be carried out using a web-based m-Health tool, mobile phone application. The quantitative primary results will be compared between the two groups using analysis of covariance, adjusting for age and sex. Multivariate analysis will be carried out to examine the association of the intervention with life habits, control of cardiovascular risk factors as well as the evolution after discharge in respect of cardiovascular events, emergency and re-entry views.
详细描述
Design: A randomized single-blind, parallel-group, controlled clinical trial performed on patients with coronary heart disease who underwent a percutaneous coronary intervention with stent placement in the Cardiology Service of a public reference hospital complex providing specialist care in the province of Cadiz, Spain, in which 1500 coronary interventions procedures are performed per year.
Randomization and Blinding: The randomization and allocation to each group (1:1, intervention and usual care) are based on computer-generated random numbers. The researchers responsible for the study do not participate in the allocation of the participants. Due to the kind of intervention, blinding is not possible when the participants are allocated to groups. To minimize any bias, objective clinical variables are measured in the evaluation visit and the analyses are performed by blinded researchers.
Study Sample: The participants are eligible to participate if they have a confirmed diagnosis of coronary heart disease and undergo percutaneous coronary intervention. Furthermore, the participants must comply with the criteria explained in the section.
Sample Size: To detect a medium effect size of Cohen's d of 0.5 regarding adherence to the Mediterranean diet (8.6 ± 2.0 points), physical activity (216 ±92 minutes/day), nicotine dependence (1.50± 2.14 points), and therapeutic adherence (6.47±1.23 points), a 95% confidence interval and a power of 80%, the sample size is estimated at 80 patients in each group. Assuming a 20% loss to follow-up, 200 participants will be recruited, 100 in each arm, intervention and usual care.
Recruitment: After the percutaneous coronary intervention and during admission, the nurse will recruit eligible patients and their care partners, will ask them to sign the informed consent, perform the initial assessment and organize a programmed visit after 3,6 and 12 months. A card will be provided with the dates of the appointments and a telephone number for any changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with coronary heart disease
- •Under the age of 75
- •Have a mobile phone, with the ability to receive text messages and with internet access
排除标准
- •Severe heart failure
- •Physical disability
- •Congenital heart disease
- •Rheumatic etiology disease
结局指标
主要结局
Change in Frequency of food consumption
时间窗: Month 3, 6 and 12
A Food-frequency questionnaire with 20 food items (unit of measure: number of times per month, week and day
Change in Therapeutic adherence
时间窗: Month 3, 6 and 12
A 8 items questionnaire (Total score: 8 points. Good therapeutic adherence= 8 points. Poor therapeutic adherence= 1-7 points)
Change in Adherence to the Mediterranean diet
时间窗: Month 3, 6 and 12
A 14-item Questionnaire of Mediterranean diet adherence (unit of measure: points. Each item is scored 0 or 1. The total Mediterranean diet score ranges from 0 to 14 points. The higher the score, the higher the degree of adherence to the Mediterranean Diet.
Change in Level of physical activity
时间窗: Month 3, 6 and 12
International Physical Activity Questionnaire (IPAQ) (unit of measure: minutes of exercise/ day. Minimum: Walk at least 30 minutes a day, 5 times a week (150 minutes a week). Do higher values represent a better outcome.
Change in Test for nicotine dependence
时间窗: Month 3, 6 and 12
(Unit of measure: points. Less than 4 points, low dependency; between 4 and 6 points, medium dependency; equal to or greater than 7 points, high dependency).
Change in Knowledge about cardiovascular disease using a questionnaire
时间窗: Month 3, 6 and 12
A 24-item questionnaire (scale 0-5 each item. Do higher values represent a better outcome)
Change in Usability and satisfaction with the application
时间窗: Month 3, 6 and 12
A 22 item questionnaire 22 item questionnaire to assess user acceptability of mobile health interventions. (6-point scale, level of disagreement to agreement with each item concerning the usability of the apps. Do higher values represent a better outcome)
次要结局
未报告次要终点