Chronic Obstructive Pulmonary Disease Self-Management in Three LMICs: A Pilot Randomized Trial

GECo-2 trial investigators

doi:10.1164/rccm.202303-0505OC

Chronic Obstructive Pulmonary Disease Self-Management in Three LMICs: A Pilot Randomized Trial

GECo-2 trial investigators

Centre for Health Economics

Research output: Contribution to journal › Article › peer-review

Abstract

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) disproportionately affects low- and middle-income countries (LMICs). Health systems are ill-prepared to manage the increase in COPD cases.

METHODS: We carried out a pilot effectiveness-implementation randomized field trial of a community health worker (CHW)-supported, one-year self-management intervention in individuals with COPD grade B-D. The study took place in low-resource settings of Nepal, Peru, and Uganda. The primary outcome was the St. George's Respiratory Questionnaire (SGRQ) score at one year. We evaluated differences in moderate-to-severe exacerbations, all-cause hospitalizations and the EuroQol score (EQ5D-3L) at 12 months.

RESULTS: We randomly assigned 239 participants (119 control, 120 intervention) with grade B-D COPD to a multi-component, CHW-supported intervention or standard of care and COPD education. 25 participants (21%) died or were lost to follow-up in the control arm compared to 11 (9%) in the intervention arm. At 12 months, there was no difference in mean total SGRQ scores between intervention and control arms (34.7 vs. 34.0 points; adjusted mean difference 1.0, 95% CI -4.2 to 6.1; p=0.71). The intervention arm had a higher proportion of hospitalizations (10% vs 5.2%; adjusted odds ratio 2.2, 95% CI 0.8-7.5; p=0.15) at 12 months compared to controls.

CONCLUSION: A CHW-based intervention to support self-management of acute exacerbations of COPD in three resource-poor settings did not result in differences in SGRQ scores at one year. Fidelity was high, and intervention engagement was moderate. While results cannot differentiate between a failed intervention or implementation, it nonetheless suggests that we need to revisit our strategy. Clinical trial registration available at www.

CLINICALTRIALS: gov, ID: NCT03359915. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Original language	English
Journal	American Journal of Respiratory and Critical Care Medicine
Early online date	12 Sept 2023
DOIs	https://doi.org/10.1164/rccm.202303-0505OC
Publication status	E-pub ahead of print - 12 Sept 2023

Bibliographical note

This is an author-produced version of the published paper. Uploaded in accordance with the University’s Research Publications and Open Access policy.

Access to Document

10.1164/rccm.202303-0505OC

pollard-et-al-2023-chronic-obstructive-pulmonary-disease-self-management-in-three-lmics-a-pilot-randomized-trial
This is an author-produced version of the published paper. Uploaded in accordance with the University’s Research Publications and Open Access policy.
Accepted author manuscript, 1.27 MBLicence: CC BY

Cite this

@article{5776b087533f435386780bc941431d8a,

title = "Chronic Obstructive Pulmonary Disease Self-Management in Three LMICs: A Pilot Randomized Trial",

abstract = "INTRODUCTION: Chronic obstructive pulmonary disease (COPD) disproportionately affects low- and middle-income countries (LMICs). Health systems are ill-prepared to manage the increase in COPD cases.METHODS: We carried out a pilot effectiveness-implementation randomized field trial of a community health worker (CHW)-supported, one-year self-management intervention in individuals with COPD grade B-D. The study took place in low-resource settings of Nepal, Peru, and Uganda. The primary outcome was the St. George's Respiratory Questionnaire (SGRQ) score at one year. We evaluated differences in moderate-to-severe exacerbations, all-cause hospitalizations and the EuroQol score (EQ5D-3L) at 12 months.RESULTS: We randomly assigned 239 participants (119 control, 120 intervention) with grade B-D COPD to a multi-component, CHW-supported intervention or standard of care and COPD education. 25 participants (21%) died or were lost to follow-up in the control arm compared to 11 (9%) in the intervention arm. At 12 months, there was no difference in mean total SGRQ scores between intervention and control arms (34.7 vs. 34.0 points; adjusted mean difference 1.0, 95% CI -4.2 to 6.1; p=0.71). The intervention arm had a higher proportion of hospitalizations (10% vs 5.2%; adjusted odds ratio 2.2, 95% CI 0.8-7.5; p=0.15) at 12 months compared to controls.CONCLUSION: A CHW-based intervention to support self-management of acute exacerbations of COPD in three resource-poor settings did not result in differences in SGRQ scores at one year. Fidelity was high, and intervention engagement was moderate. While results cannot differentiate between a failed intervention or implementation, it nonetheless suggests that we need to revisit our strategy. Clinical trial registration available at www.CLINICALTRIALS: gov, ID: NCT03359915. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",

author = "{GECo-2 trial investigators} and Pollard, {Suzanne L} and Trishul Siddharthan and Shakir Hossen and Rykiel, {Natalie A} and Oscar Flores-Flores and Patricia Alupo and Shumonta Quaderi and Ivonne Ascencio and Barber, {Julie A} and Ram Chandyo and {Kumar Das}, Santa and Gonzalo Gianella and Bruce Kirenga and Kelli Grunstra and Miranda, {J Jaime} and Sakshi Mohan and Federico Ricciardi and Sharma, {Arun K} and Laxman Shrestha and Soares, {Marta O} and Wosu, {Adaeze C} and Hurst, {John R} and William Checkley",

note = "This is an author-produced version of the published paper. Uploaded in accordance with the University{\textquoteright}s Research Publications and Open Access policy.",

year = "2023",

month = sep,

day = "12",

doi = "10.1164/rccm.202303-0505OC",

language = "English",

journal = "American Journal of Respiratory and Critical Care Medicine",

issn = "1073-449X",

publisher = "American Thoracic Society",

}

TY - JOUR

T1 - Chronic Obstructive Pulmonary Disease Self-Management in Three LMICs

T2 - A Pilot Randomized Trial

AU - GECo-2 trial investigators

AU - Pollard, Suzanne L

AU - Siddharthan, Trishul

AU - Hossen, Shakir

AU - Rykiel, Natalie A

AU - Flores-Flores, Oscar

AU - Alupo, Patricia

AU - Quaderi, Shumonta

AU - Ascencio, Ivonne

AU - Barber, Julie A

AU - Chandyo, Ram

AU - Kumar Das, Santa

AU - Gianella, Gonzalo

AU - Kirenga, Bruce

AU - Grunstra, Kelli

AU - Miranda, J Jaime

AU - Mohan, Sakshi

AU - Ricciardi, Federico

AU - Sharma, Arun K

AU - Shrestha, Laxman

AU - Soares, Marta O

AU - Wosu, Adaeze C

AU - Hurst, John R

AU - Checkley, William

N1 - This is an author-produced version of the published paper. Uploaded in accordance with the University’s Research Publications and Open Access policy.

PY - 2023/9/12

Y1 - 2023/9/12

N2 - INTRODUCTION: Chronic obstructive pulmonary disease (COPD) disproportionately affects low- and middle-income countries (LMICs). Health systems are ill-prepared to manage the increase in COPD cases.METHODS: We carried out a pilot effectiveness-implementation randomized field trial of a community health worker (CHW)-supported, one-year self-management intervention in individuals with COPD grade B-D. The study took place in low-resource settings of Nepal, Peru, and Uganda. The primary outcome was the St. George's Respiratory Questionnaire (SGRQ) score at one year. We evaluated differences in moderate-to-severe exacerbations, all-cause hospitalizations and the EuroQol score (EQ5D-3L) at 12 months.RESULTS: We randomly assigned 239 participants (119 control, 120 intervention) with grade B-D COPD to a multi-component, CHW-supported intervention or standard of care and COPD education. 25 participants (21%) died or were lost to follow-up in the control arm compared to 11 (9%) in the intervention arm. At 12 months, there was no difference in mean total SGRQ scores between intervention and control arms (34.7 vs. 34.0 points; adjusted mean difference 1.0, 95% CI -4.2 to 6.1; p=0.71). The intervention arm had a higher proportion of hospitalizations (10% vs 5.2%; adjusted odds ratio 2.2, 95% CI 0.8-7.5; p=0.15) at 12 months compared to controls.CONCLUSION: A CHW-based intervention to support self-management of acute exacerbations of COPD in three resource-poor settings did not result in differences in SGRQ scores at one year. Fidelity was high, and intervention engagement was moderate. While results cannot differentiate between a failed intervention or implementation, it nonetheless suggests that we need to revisit our strategy. Clinical trial registration available at www.CLINICALTRIALS: gov, ID: NCT03359915. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

AB - INTRODUCTION: Chronic obstructive pulmonary disease (COPD) disproportionately affects low- and middle-income countries (LMICs). Health systems are ill-prepared to manage the increase in COPD cases.METHODS: We carried out a pilot effectiveness-implementation randomized field trial of a community health worker (CHW)-supported, one-year self-management intervention in individuals with COPD grade B-D. The study took place in low-resource settings of Nepal, Peru, and Uganda. The primary outcome was the St. George's Respiratory Questionnaire (SGRQ) score at one year. We evaluated differences in moderate-to-severe exacerbations, all-cause hospitalizations and the EuroQol score (EQ5D-3L) at 12 months.RESULTS: We randomly assigned 239 participants (119 control, 120 intervention) with grade B-D COPD to a multi-component, CHW-supported intervention or standard of care and COPD education. 25 participants (21%) died or were lost to follow-up in the control arm compared to 11 (9%) in the intervention arm. At 12 months, there was no difference in mean total SGRQ scores between intervention and control arms (34.7 vs. 34.0 points; adjusted mean difference 1.0, 95% CI -4.2 to 6.1; p=0.71). The intervention arm had a higher proportion of hospitalizations (10% vs 5.2%; adjusted odds ratio 2.2, 95% CI 0.8-7.5; p=0.15) at 12 months compared to controls.CONCLUSION: A CHW-based intervention to support self-management of acute exacerbations of COPD in three resource-poor settings did not result in differences in SGRQ scores at one year. Fidelity was high, and intervention engagement was moderate. While results cannot differentiate between a failed intervention or implementation, it nonetheless suggests that we need to revisit our strategy. Clinical trial registration available at www.CLINICALTRIALS: gov, ID: NCT03359915. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

U2 - 10.1164/rccm.202303-0505OC

DO - 10.1164/rccm.202303-0505OC

M3 - Article

C2 - 37698443

SN - 1073-449X

JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

ER -