Chronic Obstructive Pulmonary Disease Self-Management in Three Low- and Middle-Income Countries: A Pilot Randomized Trial

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).

Keywords: COPD; community health workers; global health; self-management.

Figure 1.

Consolidated Standards of Reporting Trials diagram of participant flow through the GECo2 study.

Figure 2.

Comparison of differences in SGRQ total score and subscores (activity, impacts, symptoms) at baseline and 3-, 6-, 9-, and 12-month follow-up visits between the intervention and control arms. The blue lines represent the intervention arm, and the red lines represent the control arm. The diamond point estimates indicate the means, the thicker lines represent the 80% one-sided confidence intervals, and the thinner lines represent the 95% confidence intervals. SGRQ = St. George’s Respiratory Questionnaire.

Figure 3.

Indicators of engagement with the intervention among intervention arm participants. The top panel displays the percentage of participants, overall and in each site, at 3-, 6-, 9-, and 12-month follow-up visits, who answered “yes” to the question, “During the last 3 months, have you used your action plan?” The second panel displays the percentage of participants who answered “yes” to the question, “[Among those who did use the action plan], did your action plan help guide your decision to take medications or seek medical care?” The third panel displays the percentage of participants who answered “yes” to the question, “During the last 3 months, did you use a rescue pack?”