Background: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality in the United States. Frequent exacerbations result in higher use of emergency services and hospitalizations, leading to poor patient outcomes and high costs.
Objective: Demonstrate the feasibility of a multimodal, digitally enhanced remote monitoring, treatment, and tele-pulmonary rehabilitation intervention among patients with COPD.
Methods: In this pilot clinical trial, community-dwelling adults with moderate-severe COPD were enrolled in a multimodal digital monitoring and treatment program including a Fitbit wearable device, study app that tracked COPD-related symptoms, on-demand mobile integrated health (MIH) services for acute home-based treatment, and tele-pulmonary-rehabilitation. Participants were enrolled in the program for six months. COPD severity and health-related quality of life assessments were performed at baseline, 3 months, and 6 months. Primary feasibility outcomes include recruitment and retention rate, and participant protocol fidelity, which were reported descriptively. Exploratory clinical outcomes included patient-reported quality of life, activation, and intervention satisfaction.
Results: Over 18 months, 1,333 patients were approached and 100 (7.5%) were enrolled (mean age 66, 52% female). Ninety-six participants (96%) remained in the study for the full enrollment period. Fifty-five (55%) participated in tele-pulmonary-rehabilitation. Participants wore the Fitbit for a median of 114 days (IQR 183.6) and 16.85 hours/day (4.05), resulting in a median of 1133 minutes (243) per day. Completion rates for scheduled instruments ranged from 78-93%. Nearly all participants (85%) performed COPD ecological momentary assessment at least once with a median of 4.85 recordings. On average, a 2.48-point improvement (p=0.03) in COPD Assessment Test Score was observed from baseline to study completion. The adherence and symptom improvement metrics were not associated with baseline patient activation measures.
Conclusions: A multimodal intervention combining preventative care, symptom and biometric monitoring, and home treatment was feasible in adults living with COPD. Participants demonstrated high protocol fidelity and engagement and reported improved quality of life.