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Trial record 55 of 1411 for:    Peru

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

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 2, 2017
Last Update Posted Date December 4, 2017
Estimated Study Start Date  ICMJE December 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT03359915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE 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  ICMJE
  • 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, 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.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: John R Hurst, FRCP, PhD +442074726260 j.hurst@ucl.ac.uk
Contact: William Checkley, MD, PhD wcheckl1@jhmi.edu
Listed Location Countries  ICMJE Peru,   Nepal,   Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03359915
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE
  • Johns Hopkins University
  • Universidad Peruana Cayetano Heredia
  • Asociación Benéfica Prisma
  • Makerere University
  • University of York
  • Institute of Medicine, Tribhuvan University, Nepal
Investigators  ICMJE
Principal Investigator: John R Hurst, FRCP, PhD University College, London
PRS Account University College, London
Verification Date December 2017

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