GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries (GECo2)

Tracking Information
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; (submitted: November 27, 2017)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT03359915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 27, 2017)	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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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.; 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 ICMJE	Interventional
Study Phase	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
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.
Study Arms	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. Intervention: Behavioral: COPD Self-Management Plan; No Intervention: Control Group COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Not yet recruiting
Estimated Enrollment ICMJE; (submitted: November 27, 2017)	240
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	February 2020
Estimated Primary Completion Date	November 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact: John R Hurst, FRCP, PhD +442074726260 j.hurst@ucl.ac.uk Contact: William Checkley, MD, PhD wcheckl1@jhmi.edu
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	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	University College, London
Study Sponsor ICMJE	University College, London
Collaborators ICMJE	Johns Hopkins University; Universidad Peruana Cayetano Heredia; Asociación Benéfica Prisma; Makerere University; University of York; Institute of Medicine, Tribhuvan University, Nepal
Investigators ICMJE	Principal Investigator: John R Hurst, FRCP, PhD University College, London
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