Comparing Effectiveness of Self-management and Peer Support Communication Programs Amongst Chronic Obstructive Pulmonary Disease (COPD) Patients and Their Family Caregivers

Chronic Obstructive Pulmonary Disease (COPD) is a prevalent global condition that results in high mortality, morbidity, symptom burden, and functional limitations that impact the quality of life. COPD is the third leading cause of death in the US and a leading cause of hospitalizations. COPD patients report unmet needs in regards to information about their disease and how to manage and cope with it at an intellectual, emotional, and social level. Many COPD patients lack the information and skills that they need to correctly use their inhaled medications, manage 'breathlessness episodes', and detect early signs of a COPD exacerbation. Pulmonary rehabilitation programs are established to help COPD patients increase their exercise capacity and reduce fatigue and dyspnea with daily activity. While clinical trials testing these programs have demonstrated significant improvements in health-related quality of life and reduced dyspnea and fatigue amongst participants, it remains unclear how best to engage and motivate patients to participate in them.

Self-management support interventions which involve "collaboratively helping patients acquire and practice the skills needed to carry out disease-specific medical regimens, change their health behavior to adjust their roles for optimal function, improve day-to-day control of their disease, and improve their well-being", have been demonstrated in several trials to improve health-related quality of life, and reduce symptom burden, hospitalizations, and ED visits amongst COPD patients. However, it is still unclear which self-management support strategies employed in 'real world' settings are most effective in engaging, motivating, and enabling patients to successfully follow recommended treatments, adopt desired health behaviors, and thus achieve the desired improvements in their health outcomes.

The planned study design is a single- blinded randomized controlled trial to compare the effectiveness of two strategies for engaging and supporting COPD patients and their family caregivers in self-management of COPD. The two strategies/study arms are: 1) the 'HCP arm' where the healthcare professional (HCP) is the primary communicator about COPD self-management with the patient participants; and 2) the 'HCP plus Peer arm', where both healthcare professionals and peer mentors engage with study participants in conversations about COPD self-management using multiple channels including one- to- one and group conversations. Participants will be randomized in a 1:1 ratio into the two study arms. The trial will be conducted amongst COPD patients coming to the hospital or clinic at two study sites within Johns Hopkins Healthcare System. Recruitment from both sites and multiple settings allows for a more representative COPD patient population to be enrolled in the study, thus increasing the external validity of study findings.

The research study will answer the research question: Amongst COPD patients and their caregivers, would a dual strategy that combines healthcare professional and peer mentor delivery of COPD self- management education and support result in greater improvements in health status and quality of life, and reductions in acute healthcare services' utilization, compared to relying on healthcare professionals alone in these communications? Would such dual strategy result in reduced caregiver stress and improved coping and satisfaction? The study hypothesis is that the dual strategy of using 'HCP plus peer support' to engage and support COPD patients and caregivers will have superior outcomes to the 'HCP only' strategy in the following areas : a) Improved health- related quality of life and reduced numbers of COPD-related hospital and ED visits; b) improved patient activation, self-efficacy, and self-care behaviors; c) improved family caregivers' satisfaction and self- efficacy. These improvements will be noted at 3, 6, and 9 months compared to baseline.