GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries
NCT ID: NCT03359915
Last Updated: 2017-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2017-12-31
2020-02-29
Brief Summary
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Detailed Description
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1. 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.
2. 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.
1. 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.
2. 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.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
COPD Self-Management Plan
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.
Control Group
COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda
No interventions assigned to this group
Interventions
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COPD Self-Management Plan
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Currently has active pulmonary TB or is taking medications for pulmonary TB
* Identified as having COPD grade A as per GOLD criteria
40 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Universidad Peruana Cayetano Heredia
OTHER
Asociacion Benefica Prisma
OTHER
Makerere University
OTHER
University of York
OTHER
Institute of Medicine, Tribhuvan University, Nepal
UNKNOWN
University College, London
OTHER
Responsible Party
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Principal Investigators
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John R Hurst, FRCP, PhD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Institute of Medicine
Kathmandu, , Nepal
Universidad Peruana Cayetano Heredia
Lima, , Peru
Makerere University Lung Institute
Makerere, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Laxman Shrestha, MD
Role: primary
Jaime Miranda, MD
Role: primary
[email protected]
Role: backup
Bruce Kirenga, MD
Role: primary
References
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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.
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.
Related Links
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The Johns Hopkins Center for Global NCD Research and Training Website
Trial Twitter account - @COPDGECo
Other Identifiers
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16/0630_RCT
Identifier Type: -
Identifier Source: org_study_id