GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries (GECo2)
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ClinicalTrials.gov Identifier: NCT03359915 |
Recruitment Status : Unknown
Verified December 2017 by University College, London.
Recruitment status was: Not yet recruiting
First Posted : December 2, 2017
Last Update Posted : December 4, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Behavioral: COPD Self-Management Plan | Not Applicable |
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.
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | RCT Phase - Parallel Groups: 240 in total Control arm - 120 participants Intervention Arm - 120 participants |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries |
Estimated Study Start Date : | December 2017 |
Estimated Primary Completion Date : | November 2019 |
Estimated Study Completion Date : | February 2020 |

Arm | Intervention/treatment |
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Experimental: 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.
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Behavioral: 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. |
No Intervention: Control Group
COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda
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- Change in SGRQ [ Time Frame: 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.
- Number of Exacerbations [ Time Frame: 12 months ]Comparison of the number of COPD exacerbations in 12 months, between the intervention compared to the control arm.
- Number of Hospitalisations [ Time Frame: 12 months ]Comparison of the number of hospitalisations in 12 months, between the intervention compared to the control arm.
- Number of CHW visits [ Time Frame: 12 months ]Comparison of the number of CHW visits in 12 months, between the intervention compared to the control arm.
- Health-Economics [ Time Frame: 12 months ]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.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359915
Contact: John R Hurst, FRCP, PhD | +442074726260 | j.hurst@ucl.ac.uk | |
Contact: William Checkley, MD, PhD | wcheckl1@jhmi.edu |
Nepal | |
Institute of Medicine | |
Kathmandu, Nepal | |
Contact: Laxman Shrestha, MD laxmanshree12@gmail.com | |
Peru | |
Universidad Peruana Cayetano Heredia | |
Lima, Peru | |
Contact: Jaime Miranda, MD | |
Contact: jaime.miranda@upch.pe | |
Uganda | |
Makerere University Lung Institute | |
Makerere, Uganda | |
Contact: Bruce Kirenga, MD |
Principal Investigator: | John R Hurst, FRCP, PhD | University College, London |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT03359915 |
Other Study ID Numbers: |
16/0630_RCT |
First Posted: | December 2, 2017 Key Record Dates |
Last Update Posted: | December 4, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COPD Self-Management Action Plan |
SGRQ LMIC COPD Diagnosis |
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases |