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

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ClinicalTrials.gov Identifier: NCT03359915
Recruitment Status : Not yet recruiting
First Posted : December 2, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborators:
Johns Hopkins University
Universidad Peruana Cayetano Heredia
Asociación Benéfica Prisma
Makerere University
University of York
Institute of Medicine, Tribhuvan University, Nepal
Information provided by (Responsible Party):
University College, London

November 27, 2017
December 2, 2017
December 4, 2017
December 2017
November 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03359915 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries
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.

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.

Interventional
Not Applicable
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
Chronic Obstructive Pulmonary Disease
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.
  • 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
Siddharthan T, Pollard SL, Quaderi SA, Mirelman AJ, Cárdenas 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
240
Same as current
February 2020
November 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Yes
Contact: John R Hurst, FRCP, PhD +442074726260 j.hurst@ucl.ac.uk
Contact: William Checkley, MD, PhD wcheckl1@jhmi.edu
Nepal,   Peru,   Uganda
 
 
NCT03359915
16/0630_RCT
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University College, London
University College, London
  • Johns Hopkins University
  • Universidad Peruana Cayetano Heredia
  • Asociación Benéfica Prisma
  • Makerere University
  • University of York
  • Institute of Medicine, Tribhuvan University, Nepal
Principal Investigator: John R Hurst, FRCP, PhD University College, London
University College, London
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP