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

Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: COPD Self-Management Plan

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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Kathmandu, Nepal
    • Institute of Medicine
• Peru
  • Lima, Peru
    • Universidad Peruana Cayetano Heredia
• Uganda
  • Makerere, Uganda
    • Makerere University Lung Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Johns Hopkins University; Makerere University; Universidad Peruana Cayetano Heredia; University of York; Asociacion Benefica Prisma; Institute of Medicine, Tribhuvan University, Nepal
• Investigators: Principal Investigator: John R Hurst, FRCP, PhD, University College, London

Publications and helpful links

General 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.

Helpful Links

• The Johns Hopkins Center for Global NCD Research and Training Website
• Trial Twitter account - @COPDGECo

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Self-Management; LMIC; Action Plan; SGRQ; COPD Diagnosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 16/0630_RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No