Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Change in SGRQ
研究概览
简要总结
This study will randomise people with clinically significant COPD (GOLD Grade B-D) to usual care or provision of a self-management action plan supported by monthly follow-up visits from a community health worker trained in the use of the action plan. The primary outcome will be health-status: a comparison of the change in St. George's Respiratory Questionnaire (SGRQ) between baseline and 12 months in the two groups. We will randomise 240 people from three low- and middle-income countries, namely Nepal, Peru and Uganda. We will also examine the feasibility of implementing our self-management action plan intervention at scale.
详细描述
The investigators will determine whether a self-directed COPD Action Plan for the management of COPD exacerbations can be implemented with trained community health workers (CHWs). The investigators hypothesise that COPD action plans with disease-specific education and support from a CHW will lead to improved quality of life and will be locally-appropriate, acceptable, and feasible to implement.
- Clinical Aim 1: Assess the clinical effectiveness of CHW-supported COPD Action Plans in LMICs by comparing change in disease-specific quality of life measures (SGRQ) at one year.
- Implementation Aim 1: Assess the appropriateness, acceptability, and feasibility of implementing a CHW-supported, self-directed COPD Action Plan for management of COPD exacerbations.
The investigators will also determine whether a CHW-supported, self-directed COPD Action Plan is cost-effective, accounting for implementation realities. We hypothesise that COPD Action Plans are a cost-effective intervention, as measured by the incremental QALY.
- Clinical Aim 2: Assess the cost-effectiveness of COPD Action Plans in terms of health-related costs and health benefits and explore broader cost implications to productivity.
- Implementation Aim 2: Explore how the value of the COPD Action Plans is affected by both implementation factors that restrict optimal provision ('constraints') and sub-group differences, which have implications for equity.
The final design of our intervention will be informed by formative work prior to commencement of the main study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants aged ≥40 years
- •Full-time resident in the area (living in area > 6 months)
- •Able to perform adequate quality spirometry
- •Capable of providing informed consent
- •Identified as having COPD grade B-D as per GOLD criteria
排除标准
- •Pregnancy (self-reported)
- •Currently has active pulmonary TB or is taking medications for pulmonary TB
- •Identified as having COPD grade A as per GOLD criteria
研究组 & 干预措施
Intervention Group
Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.
干预措施: COPD Self-Management Plan (Behavioral)
Control Group
COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda
结局指标
主要结局
Change in SGRQ
时间窗: 12 months
Comparison of the change in SGRQ between baseline and 12 months, in the intervention compared to the control arm. b) Implementation Aim 1: Assess the appropriateness, acceptability and feasibility of using questionnaires and PEF to identify COPD cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health.
次要结局
- Number of Exacerbations(12 months)
- Number of CHW visits(12 months)
- Number of Hospitalisations(12 months)
- Health-Economics(12 months)