Feasibility Trial of a Comprehensive, Highly Patient-Centered COPD Self-Management Support Program

Purpose: To test the feasibility of a novel self-management support intervention for people with chronic obstructive pulmonary disease (COPD). Methods: We conducted a feasibility randomized controlled trial involving patients ≥40 years with severe or very severe COPD in New York, NY (n=59). Community health workers screened patients and addressed barriers to COPD self-management. Patients were also offered home-based pulmonary rehabilitation (HBPR) and an antibiotic and steroid rescue pack. Control patients received general COPD education. Clinical outcomes for intervention and control were compared by difference-in-differences (DiD) at baseline and 6 months. The study was not powered for statistically significant differences for any measure. Feasibility measures were collected at 6 months. Results: There were high rates of completion of intervention activities, including 75% of patients undergoing evaluation for and participating in HBPR. Most (92%) intervention patients said the program was very or extremely helpful and 96% said they would participate again. Clinical outcomes generally favored the intervention: COPD assessment test, DiD -1.1 (95% CI -5.9 to 3.6); 6-minute walk test distance, DiD 7.4 meters (95% CI -45.1 to 59.8); self-reported hospitalizations, DiD -9.8% (95% CI -42.3% to 22.8%); medication adherence, DiD 7.7% (-29.6%, 45.0%), and PAAQ, DiD 86 (95% CI -283 to 455). Intervention patients reported more ED visits, DiD 10.6% (95% CI 17.7% to 38.8%). Conclusions: A highly patient-centered self-management support intervention for people with COPD was well received by patients and associated with potential improvements in clinical and self-management outcomes. A fully powered study of the intervention is warranted. Keywords: Medication adherence; clinical trials; patient-centered; pulmonary rehabilitation