Chronic Obstructive Pulmonary DiseaseGECo2NCT03359915
GECo: Implementation and Effectiveness of COPD Self Management Action Plans in Low and Middle Income Countries
A study testing COPD Self-Management Plan in people with Chronic Obstructive Pulmonary Disease, run by University College, London at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD Self-Management Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2017to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
William Checkley, MD, PhD contact
3 sites in 3 countries
Nepal1 site
Institute of Medicine
Kathmandu
Laxman Shrestha, MD, laxmanshree12@gmail.com
Peru1 site
Universidad Peruana Cayetano Heredia
Lima
Jaime Miranda, MD
jaime.miranda@upch.pe
About this study
Official title: 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.
Read the 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- COPD Self-Management Plan
- Keywords
- COPD, Self-Management, Action Plan, SGRQ, LMIC, COPD Diagnosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD Self-Management PlanBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: COPD Self-Management Plan |
| Control Group | No intervention | COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SGRQ
Comparison of the change in SGRQ between baseline and 12 months, in the intervention compared to the control arm.
- 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.
Measured: 12 months
Secondary outcomes (4)
Number of Exacerbations
Comparison of the number of COPD exacerbations in 12 months, between the intervention compared to the control arm.
Measured: 12 months
Number of Hospitalisations
Comparison of the number of hospitalisations in 12 months, between the intervention compared to the control arm.
Measured: 12 months
Number of CHW visits
Comparison of the number of CHW visits in 12 months, between the intervention compared to the control arm.
Measured: 12 months
Health-Economics
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT Phase - Parallel Groups: 240 in total Control arm - 120 participants Intervention Arm - 120 participants
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Universidad Peruana Cayetano Heredia, Asociacion Benefica Prisma, Makerere University, University of York, Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Responsible party
- Sponsor
- Investigators
- John R Hurst, FRCP, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359915
- Sponsor's protocol ID
- 16/0630_RCT
- Acronym
- GECo2
- Status last verified
- Dec 2017
- First submitted
- 27 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37698443Siddharthan 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.
PubMed 30340648
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries
- ClinicalTrials.gov ID
- NCT03359915
- Acronym / sponsor ID
- GECo2 / 16/0630_RCT
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Self-Management, Action Plan, SGRQ, LMIC, COPD Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Universidad Peruana Cayetano Heredia, Asociacion Benefica Prisma, Makerere University, University of York, Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Study start
- Dec 2017 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT Phase - Parallel Groups: 240 in total Control arm - 120 participants Intervention Arm - 120 participants
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: COPD Self-Management PlanPatient 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. |
| Control Group | No intervention | –COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD Self-Management PlanPatient 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. | Behavioural | Intervention Group |
Primary outcome
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.
4 secondary outcomes
Number of Exacerbations
Time frame: 12 months
Number of Hospitalisations
Time frame: 12 months
Number of CHW visits
Time frame: 12 months
Health-Economics
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Derived from this study: PubMed 37698443Pollard 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.
- Derived from this study: PubMed 30340648Siddharthan 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.
- Trial Twitter account - @COPDGECoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Checkley, MD, PhD contact
John R Hurst, FRCP, PhD principal investigator
University College, London
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD Self-Management Plan in people with Chronic Obstructive Pulmonary Disease, run by University College, London at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nepal, Peru, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John R Hurst, FRCP, PhD (+442074726260, j.hurst@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SGRQ (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.