Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREATHE2 study

Background: Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models. Methods: We conducted a single-blinded RCT comparing the effectiveness of two strategies to support patients with COPD. The strategies were ‘Health Care Professional (HCP)’ and ‘HCP Plus Peer’ support. Peer support was provided by patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter. We enrolled patients receiving treatment at inpatient and outpatient settings. Patients were encouraged to invite one family-caregiver to enroll with them. The primary outcome measure was the change in HRQOL at 6 months post enrollment. Secondary outcomes included COPD-related and all-cause hospitalizations and ED visits. Caregiver outcomes included preparedness for caregiving, caregiver stress, and coping. Results: A total of 292 patients as well as 50 family-caregivers were enrolled. The average patient age was 67.3 yrs. (SD 9.4), 61% were female and 26% were African-Americans. The majority of caregivers were females (68%) and were a spouse/partner (58%). Discussion: This study tested a dual strategy for providing support to patients with COPD that incorporates peer and health care professional support. The study had minimal exclusion criteria. If shown effective, the study offers a program of peer support that can be readily implemented in health care settings.