菲律宾社区卫生评估计划（CHAP-P）糖尿病健康促进计划在中低收入国家的应用：一项群组随机对照试验的研究方案。
The Community Health Assessment Program in the Philippines (CHAP-P) diabetes health promotion program for low- to middle-income countries: study protocol for a cluster randomized controlled trial.
机构信息
Department of Family Medicine, McMaster University, 1280 Main St W, Hamilton, Ontario, L8S 4L8, Canada.
School of Medicine, Ateneo de Zamboanga University, La Purisima St, 7000, Zamboanga City, Philippines.
出版信息
BMC Public Health. 2019 Jun 3;19(1):682. doi: 10.1186/s12889-019-6974-z.
BACKGROUND
Type 2 diabetes is increasing globally, with the highest burden in low- to middle-income countries (LMICs) such as the Philippines. Developing effective interventions could improve detection, prevention, and treatment of diabetes. The Cardiovascular Health Awareness Program (CHAP), an evidence-based Canadian intervention, may be an appropriate model for LMICs due to its low cost, ease of implementation, and focus on health promotion and disease prevention. The primary aim of this study is to adapt the CHAP model to a Philippine context as the Community Health Assessment Program in the Philippines (CHAP-P) and evaluate the effect of CHAP-P on glycated hemoglobin (HbA1c) compared to a random sample of community residents in control communities.
METHODS
Six-month, 26-community (13 intervention, 13 control) parallel cluster randomized controlled trial in Zamboanga Peninsula, an Administrative Region in the southern Philippines. Criteria for community selection include: adequate political stability, connection with local champions, travel feasibility, and refrigerated space for materials. The community-based intervention, CHAP-P sessions, are volunteer-led group sessions with chronic condition assessment, blood pressure monitoring, and health education. Three participant groups will be involved: 1) Random sample of community participants aged 40 or older, 100 per community (1300 control, 1300 intervention participants total); 2) Community members aged 40 years or older who attended at least one CHAP-P session; 3) Community health workers and staff facilitating sessions.
PRIMARY OUTCOME
mean difference in HbA1c at 6 months in intervention group individuals compared to control.
SECONDARY OUTCOMES
modifiable risk factors, health utilization and access (individual); diabetes detection and management (cluster). Evaluation also includes community process evaluation and cost-effectiveness analysis.
DISCUSSION
CHAP has been shown to be effective in a Canadian setting. Individual components of CHAP-P have been piloted locally and shown to be acceptable and feasible. This study will improve understanding of how best to adapt this model to an LMIC setting, in order to maximize prevention, detection, and management of diabetes. Results may inform policy and practice in the Philippines and have the potential to be applied to other LMICs.
TRIAL REGISTRATION
ClinicalTrials.gov ( NCT03481335 ), registered March 29, 2018.
背景
2 型糖尿病在全球范围内呈上升趋势，菲律宾等中低收入国家（LMICs）的负担最重。开发有效的干预措施可以改善糖尿病的检测、预防和治疗。心血管健康意识计划（CHAP）是一种基于证据的加拿大干预措施，由于其成本低、易于实施以及侧重于促进健康和预防疾病，因此可能是 LMICs 的合适模式。这项研究的主要目的是将 CHAP 模型改编为菲律宾背景，即菲律宾社区健康评估计划（CHAP-P），并评估 CHAP-P 对糖化血红蛋白（HbA1c）的影响与对照社区中随机选择的社区居民相比。
方法
在菲律宾南部行政区域三宝颜半岛进行为期 6 个月、26 个社区（13 个干预组，13 个对照组）的平行聚类随机对照试验。社区选择标准包括：有足够的政治稳定性、与当地拥护者的联系、可行的旅行和材料冷藏空间。以社区为基础的干预措施，即 CHAP-P 会议，是由志愿者领导的慢性病评估小组会议，包括血压监测和健康教育。将涉及三个参与者群体：1）每个社区随机抽取 40 岁或以上的社区参与者，每个社区 100 人（对照组 1300 人，干预组 1300 人）；2）参加至少一次 CHAP-P 会议的 40 岁或以上的社区成员；3）促进会议的社区卫生工作者和工作人员。
主要结果
干预组个体与对照组个体在 6 个月时 HbA1c 的平均差异。
次要结果
可改变的危险因素、健康利用和获得（个体）；糖尿病检测和管理（集群）。评估还包括社区过程评估和成本效益分析。
讨论
CHAP 在加拿大的应用效果已得到证实。CHAP-P 的个别组成部分已在当地进行试点，结果表明是可以接受和可行的。这项研究将提高对如何将这种模式在 LMIC 环境中进行最佳调整的理解，以便最大限度地预防、检测和管理糖尿病。研究结果可能会为菲律宾的政策和实践提供信息，并有可能应用于其他 LMICs。
试验注册
ClinicalTrials.gov（NCT03481335），于 2018 年 3 月 29 日注册。
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