Chronic Obstructive Pulmonary Disease Self-Management in Three Low- and Middle-Income Countries: A Pilot Randomized Trial
Suzanne L. Pollard, Trishul Siddharthan, Shakir Hossen, Natalie A. Rykiel, Oscar Flores-Flores, Patricia Alupo, Shumonta Quaderi, I.S.I. Ascencio, Julie Barber, Ram K. Chandyo, Santa Kumar Das, Gonzalo Gianella, Bruce Kirenga, Kelli Grunstra, J. Jaime Miranda, Sakshi Mohan, Federico Ricciardi, Arun Sharma, Laxman Shrestha, Marta Soares, Adaeze C. Wosu, John R. Hurst, William Checkley
Abstract
Abstract Objectives Chronic obstructive pulmonary disease (COPD) disproportionately affects low- and middle-income countries. Health systems are ill prepared to manage the increase in COPD cases. Methods We performed a pilot effectiveness-implementation randomized field trial of a community health worker (CHW)-supported, 1-year self-management intervention in individuals with COPD grades 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 1 year. We evaluated differences in moderate to severe exacerbations, all-cause hospitalizations, and the EuroQol score (EQ-5D-3 L) at 12 months. Measurements and Main Results We randomly assigned 239 participants (119 control arm, 120 intervention arm) with grades B–D COPD to a multicomponent, CHW-supported intervention or standard of care and COPD education. Twenty-five participants (21%) died or were lost to follow-up in the control arm compared with 11 (9%) in the intervention arm. At 12 months, there was no difference in mean total SGRQ score between the intervention and control arms (34.7 vs. 34.0 points; adjusted mean difference, 1.0; 95% confidence interval, −4.2, 6.1; P = 0.71). The intervention arm had a higher proportion of hospitalizations than the control arm (10% vs. 5.2%; adjusted odds ratio, 2.2; 95% confidence interval, 0.8, 7.5; P = 0.15) at 12 months. Conclusions 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 1 year. Fidelity was high, and intervention engagement was moderate. Although these results cannot differentiate between a failed intervention or implementation, they nonetheless suggest that we need to revisit our strategy. Clinical trial registered with www.clinicaltrials.gov (NCT03359915).