Clinical trial NCT03359915: GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries
Official title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Self-Management
Action Plan
SGRQ
LMIC
COPD Diagnosis
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Universidad Peruana Cayetano Heredia
name: Asociacion Benefica Prisma
name: Makerere University
name: University of York
name: Institute of Medicine, Tribhuvan University, Nepal
First posted: 2017-12-02
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT Phase - Parallel Groups: 240 in total Control arm - 120 participants Intervention Arm - 120 participants
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in SGRQ
timeFrame: 12 months
Secondary outcomes:
measure: Number of Exacerbations
timeFrame: 12 months
measure: Number of Hospitalisations
timeFrame: 12 months
measure: Number of CHW visits
timeFrame: 12 months
measure: Health-Economics
timeFrame: 12 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute of Medicine
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
city: Makerere
country: Uganda
facility: Makerere University Lung Institute
Study officials:
affiliation: University College, London
name: John R Hurst, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.