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Abstract
Background African–Americans are historically under-represented in SLE studies and engaging them in behavioural interventions is challenging. The Women Empowered to Live with Lupus (WELL) study is a trial conducted to examine the effectiveness of the Chronic Disease Self-Management Program (CDSMP) among African–American women with SLE. We describe enrolment and retention challenges and successful strategies of the WELL study.
Methods The Georgians Organized Against Lupus (GOAL) cohort, a population-based cohort established in Atlanta, Georgia, was used to enrol a sample of 168 African–American women with SLE into the CDSMP. The CDSMP is a 6-week, group-based programme led by peers to enhance self-management skills in people with chronic conditions. Study performance standards were predefined and close monitoring of recruitment and retention progress was conducted by culturally competent staff members. Continuous contact with participants, research coordinators’ notes and regular research team meetings served to assess barriers and define strategies needed to meet the desired recruitment and retention outcomes.
Results While no substantial barriers were identified to enrol GOAL participants into the WELL study, WELL participants faced difficulties registering for and/or completing (attending ≥4 sessions) a CDSMP workshop. Major barriers were unpredicted personal and health-related issues, misunderstanding of the scope and benefits of the intervention, and transportation problems. Early implementation of tailored strategies (eg, CDSMP scheduled on Saturdays, CDSMP delivered at convenient/familiar facilities, transportation services) helped to reduce participant barriers and achieve a CDSMP registration of 168 participants, with 126 (75%) completers. Frequent contact with participants and compensation helped to reach 92.3% retention for the 6-month survey.
Conclusions Predefined standards and monitoring of participant barriers by a culturally competent research team and proactive solutions were critical to implementing successful strategies and achieving the desired recruitment and retention outcomes of a behavioural trial involving African–American women with SLE.
Trial registration number NCT02988661.
- systemic lupus erythematosus
- patient perspective
- qualitative research
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Footnotes
Contributors All authors were involved in drafting the article and/or critically revising it for important intellectual content, and all authors approved the final version to be published. CD, KE, SSL and TB contributed to the study conception and design. CD-T and GB contributed to acquisition of data. All authors contributed to analysis and interpretation of data.
Funding The WELL study is funded by the National Institute on Minority Health and Health Disparities (R01MD010455). The GOAL cohort is supported by the Centers for Disease Control and Prevention (CDC-U01DP005119 and CDC-U01DP006488). The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Ethics approval The study was approved by the Emory Institutional Review Board and Grady Health System Research Oversight Committee. All study participants signed informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data sharing not applicable as no data sets generated and/or analysed for this study. All data relevant to the study are included in the article or uploaded as supplementary information. The WELL study is an ongoing behavioural trial registered on 7 December 2016. We will share individual de-identified data (and metadata and trial documents) via a data use agreement after the study is completed and primary papers are published. Individual de-identified data provided in this report are available upon reasonable request (or a data use agreement). The assessment of recruitment and retention challenges, as well as strategies to overcome barriers reported in this study, was an organic process that took advantage of ongoing notes by research staff and discussions by the research team (primarily qualitative data). Thus, no individual data are available and data sharing is not applicable to this specific study.
Author note Although the study was performed in the US, this report includes traditional English terms to meet the UK editorial style.