Addressing the Challenges of Recruitment and Retention in Sleep and Circadian Clinical Trials

Abstract

Objective/Background: Sleep and circadian disorders are prevalent worldwide and frequently comorbid with physical and mental illnesses. Thus, recruiting and retaining samples for sleep and circadian research are high priorities. The aims of this paper are to highlight barriers to recruitment and retention for participants with sleep and/or circadian dysfunction, and to share strategies used across two randomized controlled trials (RCTs) testing the efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to address these challenges. Participants:The first RCT recruited 176 adolescents with an evening circadian chronotype, who were 'at-risk' in at least one of five health domains: behavioral, cognitive, emotional, physical, and social. The second RCT recruited 121 low-income, racial/ethnic minority adults diagnosed with severe mental illness (SMI) and comorbid sleep and/or circadian dysfunction. Methods:The current study examined participant, environment, and research factors that impacted recruitment and retention of participants with sleep and/or circadian dysfunction, and identified strategies to enhance recruitment and retention.Results: Strategies used to recruit participants included: community-based recruiting, reducing stigma, and alleviating burdensome sleep data collection. Strategies used to retain participants in our studies included: flexible scheduling, mitigating participant barriers, building rapport with participants through empathic and positive interactions, creative problem-solving, consulting participant networks, and utilizing incentives and other positive engagement tools. Conclusion:Both at-risk adolescents and low-income, minority adults with comorbid SMI and sleep and/or circadian dysfunction experience significant barriers to research participation. Recruitment and retention strategies were creatively tailored to meet the unique barriers of these diverse populations.

A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting.

“…A RANDOMIZED CONTROLLED TRIAL OF TRANS-C discussed our approach to retention and barriers to implementation elsewhere Yu et al, 2020).…”

Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action

“…Aside from these key strategies that were commonly referred to across the literature, some articles also highlighted the following enabling practices which may be relevant to clinical trials, including leadership from organisations and management around inclusion [ 38 , 40 , 42 ]; partnering with local healthcare centres/practices and clinical staff [ 20 , 35 , 43 , 44 , 49 , 67 , 71 ]; non-discriminatory inclusion/exclusion criteria [ 35 , 48 , 53 , 64 , 72 ]; recruitment targets for diverse groups [ 48 , 52 , 53 , 64 , 72 ]; electronic database to track participants throughout the study [ 44 ]; two-step method of collecting sex at birth and gender identity on data collection forms [ 46 ]; alleviating burdensome data collection [ 73 ]; study-branded items with study information, e.g. fridge magnets [ 53 , 59 ]; and family involvement [ 42 , 48 ].…”

“…First, a multi-faceted approach is essential. The vast majority of studies found that multiple strategies were required to improve inclusion [ 13 , 16 , 17 , 19 , 20 , 22 , 24 , 30 , 35 , 38 – 40 , 42 – 45 , 47 – 53 , 56 , 57 , 59 , 60 , 62 – 64 , 67 , 72 , 73 ]. Furthermore, most successful strategies had elements that operated at different levels, such as within the study team and within the community of interest.…”

Facilitators and barriers to pediatric clinical trial recruitment and retention in rural and community settings: A scoping review of the literature

“…Many articles described study team observations and “lessons learned” regarding use of different recruitment and retention approaches or frameworks, with some focusing on how recruitment and retention approaches had evolved over the course of a study. In most cases, these articles were narrative summaries of investigator experiences, 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 although, in some cases, the conclusions were supported by completing analysis of study records or interviews or by conducting focus groups or surveys with study staff, site personnel, or participants. 33 , 34 , 35 , 36 , 37 , 38 Two articles compared recruitment or retention outcomes across similar studies that used different recruitment or retention methods or frameworks.…”

“…The articles summarized 31 studies, with the study recruitment or retention setting varying across articles and sometimes within an article. The majority of the articles reported on at least one study conducted entirely in an urban or suburban community setting 23 , 24 , 25 , 26 , 27 , 29 , 32 , 33 , 35 , 37 , 38 , 39 , 40 , 41 , 42 ( n = 15 articles, 56%) or an unspecified community setting 29 , 30 , 34 , 35 , 44 , 45 , 47 , 48 ( n = 8 articles, 30%). Fewer articles reported on studies with recruitment or retention efforts that the investigators characterized as spanning both urban and rural community settings 31 , 36 , 40 , 43 , 46 ( n = 5 articles, 19%) or on studies with recruitment or retention efforts that occurred exclusively or predominantly in areas that investigators defined as rural 22 , 28 , 29 , 35 , 40 ( n = 5 articles, 19%).…”