Effectiveness of a Gamified App for Cardiovascular Disease Management in Primary Care: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 900
- 试验地点
- 6
- 主要终点
- Change in medication adherence
研究概览
简要总结
Cardiovascular disease is a leading cause of death and disease in Chile. It explains 27.6% of the causes of death and 14% of disabled adjusted life years in the Chilean population. Low levels of physical activity and low levels of adherence to pharmacological therapy are major risk factors for cardiovascular disease in at-risk populations. This project will design and test the effectiveness of a mobile application based on gamification theory for improving cardiovascular disease control in a population of 900 primary care patients with moderate or high cardiovascular risk levels. A randomized controlled trial was designed to test the effect of the App in improving 30% of the levels of physical activity and adherence to pharmacological therapy and a significant reduction of 20% in cardiovascular risk levels.
详细描述
Background:
Cardiovascular disease is still a major cause of death and disease in Chile. It explains 27.6% of the causes of death and 14% of disabled adjusted life years in the Chilean population. According to the Chilean National Health Survey the population with moderate and high cardiovascular risk in Chile is 25.5%.
In Chile, 80% of the population holds public health insurance and are beneficiaries of the public health care network at no co-payment. Chile has a strong primary care network. Most of its population is registered in primary care clinics and receives clinical and preventive services for free.
Control of cardiovascular risk factors such as physical activity, hypertension, and diabetes has been insufficient in Chile. Only 20% of the population with moderate or high cardiovascular risk reported adequate levels of physical activity. In addition, only 50% of the population with hypertension reaches adequate blood pressure levels and only 30% of the population with diabetes is well controlled. These insufficient standards are associated with low adherence to pharmacological therapies that do not reach the level of 50% even though medications are free of cost for this population in primary care.
There is evidence that the use of mobile applications can improve cardiovascular disease control in at-risk patients. However, there is a lack of information on the type of best application models (e.g informative, interactive, gamification-based), and on their applicability and effectiveness in real primary care settings. There is some evidence that gamified-based applications are superior that informative or interactive models. There are no well-designed trials in Latin America testing the effectiveness of gamification-based application in reducing cardiovascular risk in primary care patients.
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
- None
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
- •Adults between 30 and 65 years old
- •Included in the population-based registration system of primary care clinics in Santiago (La Pintana-LP), Talca (San Clemente-SC) and Concepción (Giguayante-Ch)
- •Individuals with a moderate (10-15%) or high (>15%) cardiovascular risk level according to the National Chilean Guidelines adapted from the Framingham scale.
- •Individuals with a personal smartphone or with access to a smartphone from a close family relative identified as caring supporters by them.
排除标准
- •Adults not in the year range
- •Adults not cognitive competent (e.g not able to answer a personal survey)
- •Individuals with low or very low cardiovascular risk -
结局指标
主要结局
Change in medication adherence
时间窗: Change from baseline medication adherence at 18 months
Compliance with pharmacologic therapy estimated using the the Adherence to Refills and Medications Scale (ARMS). Unit of Measure : Scale units (Score 12 to 28 units)
Change in functional capacity
时间窗: Change from baseline in functional capacity at 18 months
The functional capacity of a random sample of 50% (450) of participants will be estimated based on the 6-minute walk test. Unit of Measure: Meters
Change in level of physical activity
时间窗: Change from baseline in level of physical activity at 18 months
The level of physical activity (vigorous, moderate, mild) of participants will be estimated based on the International Physical Questionnaire (IPAQ) which expresses the energy expended by individuals in MET/min/week. Unit of Measure: MET-minutes/week
Change in fatigue level
时间窗: Change from baseline in fatigue level at 18 months
The level of fatigue and dyspnea will be estimated using the Borg Scale, which is a component of the 6-minute walk test. Unit of Measure: Scale units (Score: 0 to 10 units)
次要结局
- Change in cardiovascular risk level(Change from baseline in cardiovascular risk level at 18 months)
