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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Tracking Information | |||||
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First Submitted Date ICMJE | November 27, 2017 | ||||
First Posted Date ICMJE | December 2, 2017 | ||||
Last Update Posted Date | December 4, 2017 | ||||
Estimated Study Start Date ICMJE | December 2017 | ||||
Estimated Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries | ||||
Official Title ICMJE | Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries | ||||
Brief Summary | 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. | ||||
Detailed Description | 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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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | 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 |
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Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||
Intervention ICMJE | 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.
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Study Arms ICMJE |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
240 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 2020 | ||||
Estimated Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Nepal, Peru, Uganda | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03359915 | ||||
Other Study ID Numbers ICMJE | 16/0630_RCT | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University College, London | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University College, London | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University College, London | ||||
Verification Date | December 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |