Background Recruitment and retention are two significant barriers in research, particularly for historically underrepresented groups, including racial and ethnic minorities, patients who are low-income, or people with substance use or mental health issues. Chronic obstructive pulmonary disease (COPD) is the third leading cause of death and disproportionately affects many underrepresented groups. The lack of representation of these groups in research limits the generalizability and applicability of clinical research and results. In this paper we describe our experience and rates of recruitment and retention of underrepresented groups for the Aides in Respiration (AIR) COPD Health Coaching Study. Methods A priori design strategies included minimizing exclusion criteria, including patients in the study process, establishing partnerships with the community clinics, and ensuring that the health coaching intervention was flexible enough to accommodate patient needs. Results Challenges to recruitment included lack of spirometric data in patient records, space constraints at the clinic sites, barriers to patient access to clinic sites, lack of current patient contact information and poor patient health. Of 282 patients identified as eligible, 192 (68%) were enrolled in the study and 158 (82%) completed the study. Race, gender, educational attainment, severity of disease, health literacy, and clinic site were not associated with recruitment or retention. However, older patients were less likely to enroll in the study and patients who used home oxygen or had more than one hospitalization during the study period were less likely to complete the study. Three key strategies to maximize recruitment and retention were identified during the study: incorporating the patient perspective, partnering with the community clinics, and building patient rapport. Conclusions While the AIR study included design features to maximize the recruitment and retention of patients from underrepresented groups, additional challenges were encountered and responded to during the study. We also identified three key strategies recommended for future studies of COPD and similar conditions. Incorporating the approaches described into future studies may increase participation rates from underrepresented groups, providing results that can be more accurately applied to patients who carry a disparate burden of disease. Trial registration This trial was registered at ClinicalTrial.gov at identifier NCT02234284 on August 12, 2014. Descriptor number: 2.9 Racial, ethnic, or social disparities in lung disease and treatment.

These results help inform expectations regarding the limitations and benefits of health coaching for patients with COPD. They may be useful to health policy experts in assessing the potential value of reimbursement and incentives for health coaching-type activities for patients with chronic disease. Clinical trial registered with www.clinicaltrials.gov (NCT02234284).

BackgroundChronic obstructive pulmonary disease (COPD) severely hinders quality of life for those affected and is costly to the health care system. Care gaps in areas such as pharmacotherapy, inhaler technique, and knowledge of disease are prevalent, particularly for vulnerable populations served by community clinics. Non-professionally licensed health coaches have been shown to be an effective and cost-efficient solution in bridging care gaps and facilitating self-management for patients with other chronic diseases, but no research to date has explored their efficacy in improving care for people living with COPD.MethodThis is multi-site, single blinded, randomized controlled trial evaluates the efficacy of health coaches to facilitate patient self-management of disease and improve quality of life for patients with moderate to severe COPD. Spirometry, survey, and an exercise capacity test are conducted at baseline and at 9 months. A short survey is administered by phone at 3 and 6 months post-enrollment. The nine month health coaching intervention focuses on enhancing disease understanding and symptom awareness, improving use of inhalers; making personalized plans to increase physical activity, smoking cessation, or otherwise improve disease management; and facilitating care coordination.DiscussionThe results of this study will provide evidence regarding the efficacy and feasibility of health coaching to improve self-management and quality of life for urban underserved patients with moderate to severe COPD.Trial registrationClinicalTrials.gov identifier NCT02234284. Registered 12 August 2014.

PURPOSE Poor adherence to medications is more prevalent for chronic obstructive pulmonary disease (COPD) than for other chronic conditions and is associated with unfavorable health outcomes. Few interventions have successfully improved adherence for COPD medications; none of these use unlicensed health care personnel. We explored the efficacy of lay health coaches to improve inhaler adherence and technique.METHODS Within a randomized controlled trial, we recruited English-and Spanish-speaking patients with moderate to severe COPD from urban, public primary care clinics serving a low-income, predominantly African American population. Participants were randomized to receive 9 months of health coaching or usual care. Outcome measures included self-reported adherence to inhaled controller medications in the past 7 days and observed technique for all inhalers. We used generalized linear models, controlling for baseline values and clustering by site. RESULTSBaseline adherence and inhaler technique were uniformly poor and did not differ by study arm. At 9 months, health-coached patients reported a greater number of days of adherence compared with usual care patients (6.4 vs 5.5 days; adjusted P = .02) and were more likely to have used their controller inhalers as prescribed for 5 of the last 7 days (90% vs 69%; adjusted P = .008). They were more than 3 times as likely to demonstrate perfect technique for all inhaler devices (24% vs 7%; adjusted P = .01) and mastery of essential steps (40% vs 11%; adjusted P <.001).CONCLUSIONS Health coaching may provide a scalable model that can improve care for people living with COPD.

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