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

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/)