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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 : Unknown
Verified December 2017 by University College, London.
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2017
Last Update Posted : December 4, 2017
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: COPD Self-Management Plan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Official Title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020
Arms and Interventions
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Arm Intervention/treatment
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.
 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.
No Intervention: Control Group
COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Number of Hospitalisations [ Time Frame: 12 months ]
    Comparison of the number of hospitalisations in 12 months, between the intervention compared to the control arm.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359915


Contacts
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Contact: John R Hurst, FRCP, PhD +442074726260 j.hurst@ucl.ac.uk
Contact: William Checkley, MD, PhD wcheckl1@jhmi.edu

Locations
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Nepal
Institute of Medicine
Kathmandu, Nepal
Contact: Laxman Shrestha, MD       laxmanshree12@gmail.com   
Peru
Universidad Peruana Cayetano Heredia
Lima, Peru
Contact: Jaime Miranda, MD         
Contact: jaime.miranda@upch.pe         
Uganda
Makerere University Lung Institute
Makerere, Uganda
Contact: Bruce Kirenga, MD         
Sponsors and Collaborators
University College, London
Johns Hopkins University
Universidad Peruana Cayetano Heredia
Asociacion Benefica Prisma
Makerere University
University of York
Institute of Medicine, Tribhuvan University, Nepal
Investigators
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Principal Investigator: John R Hurst, FRCP, PhD University College, London
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03359915    
Other Study ID Numbers: 16/0630_RCT
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
COPD
Self-Management
Action Plan
 SGRQ
LMIC
COPD Diagnosis
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases