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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Universidad Peruana Cayetano Heredia | OTHER |
| Asociacion Benefica Prisma | OTHER |
| Makerere University |
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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.
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.
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.
The final design of our intervention will be informed by formative work prior to commencement of the main study.
Study fieldworkers will enroll and randomise 80 adults aged ≥40 years with GOLD GRADE B-D COPD at each of the following three countries in the catchment areas of existing community census areas in Bhaktapur (Nepal), Lima (Peru), and Nakaseke (Uganda). They will then be randomised via an online system into either a control (usual care) or intervention group.
The intervention arm will receive a specific self-management plan for COPD facilitated by trained CHWs, who will then visit the participants monthly. The control group will receive basic COPD education and be reminded about the sites for their local health care providers. The primary effectiveness outcome for the study will be change in health-status (SGRQ) between baseline and 12 months, across the two groups. We will also examine the cost-effectiveness of self-management for individuals with COPD.
The investigators will also examine the feasibility of implementing our self-management action plan intervention at scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
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| Control Group | No Intervention | COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COPD Self-Management Plan | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SGRQ | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Exacerbations | Comparison of the number of COPD exacerbations in 12 months, between the intervention compared to the control arm. | 12 months |
| Number of Hospitalisations | Comparison of the number of hospitalisations in 12 months, between the intervention compared to the control arm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John R Hurst, FRCP, PhD | Contact | +442074726260 | j.hurst@ucl.ac.uk | |
| William Checkley, MD, PhD | Contact | wcheckl1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| John R Hurst, FRCP, PhD | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medicine | Kathmandu | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37698443 | Derived | Pollard SL, Siddharthan T, Hossen S, Rykiel NA, Flores-Flores O, Alupo P, Quaderi S, Ascencio I, Barber JA, Chandyo R, Das SK, Gianella G, Kirenga B, Grunstra K, Miranda JJ, Mohan S, Ricciardi F, Sharma AK, Shrestha L, Soares MO, Wosu AC, Hurst JR, Checkley W; GECo2 Trial Investigators. Chronic Obstructive Pulmonary Disease Self-Management in Three Low- and Middle-Income Countries: A Pilot Randomized Trial. Am J Respir Crit Care Med. 2023 Nov 15;208(10):1052-1062. doi: 10.1164/rccm.202303-0505OC. | |
| 30340648 |
| Label | URL |
|---|---|
| The Johns Hopkins Center for Global NCD Research and Training Website | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| OTHER |
| University of York | OTHER |
| Institute of Medicine, Tribhuvan University, Nepal | UNKNOWN |
RCT Phase - Parallel Groups: 240 in total Control arm - 120 participants Intervention Arm - 120 participants
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| 12 months |
| Number of CHW visits | Comparison of the number of CHW visits in 12 months, between the intervention compared to the control arm. | 12 months |
| Health-Economics | Assess the cost-effectiveness of a supported COPD Action Plan in terms of health-related costs and health benefits and explore broader cost implications to productivity. | 12 months |
| Universidad Peruana Cayetano Heredia | Lima | Peru |
|
| Makerere University Lung Institute | Makerere | Uganda |
|
| Derived |
| Siddharthan T, Pollard SL, Quaderi SA, Mirelman AJ, Cardenas MK, Kirenga B, Rykiel NA, Miranda JJ, Shrestha L, Chandyo RK, Cattamanchi A, Michie S, Barber J, Checkley W, Hurst JR; GECo Study Investigators. Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol. Trials. 2018 Oct 19;19(1):571. doi: 10.1186/s13063-018-2909-8. |
| Trial Twitter account - @COPDGECo | View source |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |