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

NCT03359915 | Unknown DMC

• 1 other identifier: 16/0630_RCT
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 3

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Self-Management; Action Plan; SGRQ; LMIC; COPD Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Exacerbations

  12 months

• Number of Hospitalisations

  12 months

• Number of CHW visits

  12 months

• Health-Economics

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda

Interventions

COPD Self-Management Plan BEHAVIORAL

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 Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Johns Hopkins University: collaborator
• Universidad Peruana Cayetano Heredia: collaborator
• Asociacion Benefica Prisma: collaborator
• Makerere University: collaborator
• University of York: collaborator
• Institute of Medicine, Tribhuvan University, Nepal: collaborator

Study Sites (3)

Institute of Medicine

Kathmandu, Nepal

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Makerere University Lung Institute

Makerere, Uganda

Location

Related Publications (2)

• Pollard SL, Siddharthan T, Hossen S, Rykiel NA, Flores-Flores O, Alupo P, Quaderi S, Ascencio I, Barber JA, Chandyo R, Das SK, Gianella G, Kirenga B, Grunstra K, Miranda JJ, Mohan S, Ricciardi F, Sharma AK, Shrestha L, Soares MO, Wosu AC, Hurst JR, Checkley W; GECo2 Trial Investigators. Chronic Obstructive Pulmonary Disease Self-Management in Three Low- and Middle-Income Countries: A Pilot Randomized Trial. Am J Respir Crit Care Med. 2023 Nov 15;208(10):1052-1062. doi: 10.1164/rccm.202303-0505OC.

  PMID: 37698443 DERIVED

• 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.

  PMID: 30340648 DERIVED

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John R Hurst, FRCP, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John R Hurst, FRCP, PhD

CONTACT

+442074726260; j.hurst@ucl.ac.uk

William Checkley, MD, PhD

CONTACT

wcheckl1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT Phase - Parallel Groups: 240 in total Control arm - 120 participants Intervention Arm - 120 participants

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: December 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: February 1, 2020
• Last Updated: December 4, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1); PE (1); UG (1)