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

Overview

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.

Full Title of Study: “Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Control Group
    • COPD ‘standard’ care in local setting – Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University College, London
  • Collaborator
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John R Hurst, FRCP, PhD, Principal Investigator, University College, London
  • Overall Contact(s)
    • John R Hurst, FRCP, PhD, +442074726260, j.hurst@ucl.ac.uk

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.