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

• ClinicalTrials.gov Identifier: NCT03359915
• Recruitment Status: Unknown
• First Posted: December 2, 2017
• Last Update Posted: December 4, 2017
• Sponsor: University College, London
• Collaborators: Johns Hopkins University; Universidad Peruana Cayetano Heredia; Asociacion Benefica Prisma; Makerere University; University of York; Institute of Medicine, Tribhuvan University, Nepal
• Information provided by (Responsible Party): University College, London

Tracking Information

• First Submitted Date: November 27, 2017
• First Posted Date: December 2, 2017
• Last Update Posted Date: December 4, 2017
• Estimated Study Start Date: December 2017
• Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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: Chronic Obstructive Pulmonary Disease

Intervention

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 *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 27, 2017): 240
• Original Estimated Enrollment: 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

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, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Nepal, Peru, Uganda

Administrative Information

• NCT Number: NCT03359915
• Other Study ID Numbers: 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

• Current Responsible Party: University College, London
• Original Responsible Party: Same as current
• Current Study Sponsor: University College, London
• Original Study Sponsor: Same as current

Collaborators

• Johns Hopkins University
• Universidad Peruana Cayetano Heredia
• Asociacion Benefica Prisma
• Makerere University
• University of York
• Institute of Medicine, Tribhuvan University, Nepal

Investigators

• Principal Investigator: John R Hurst, FRCP, PhD; University College, London

• PRS Account: University College, London
• Verification Date: December 2017