The trials and tribulations of enrolling couples in a randomized, controlled trial: a self-management program for hyperlipidemia as a model.

OBJECTIVE: Capitalizing on spousal support may enhance the effectiveness of interventions for chronic disease management. However, couples-based interventions present logistical challenges. We describe our experience and lessons learned while recruiting couples into the Couples Partnering for Lipid-Enhancing Strategies (CouPLES) trial. METHODS: This trial seeks to reduce serum low-density lipoprotein cholesterol levels using a couples-based intervention designed to help patients engage in self-management behaviors. We proposed enrolling 250 couples over 13 months. RESULTS: Due to practical challenges that we encountered, recruitment and enrollment lasted 21 months. Those challenges included: travel to study site; effectively marketing the study; participant burden; and establishing eligibility criteria. By modifying our protocol to address these challenges, the recruitment rate increased from 12 to 33%. CONCLUSION: In the absence of trials identifying the most effective recruitment strategies, investigators may need to experiment, amending their protocol intermittently until target enrollment numbers are reached. The lessons we present may help researchers conducting couples-based interventions develop more effective protocols. PRACTICE IMPLICATIONS: To achieve target enrollment numbers, researchers conducting couples-based interventions should consider minimizing travel to the study site; carefully crafting recruitment materials; budgeting more for participant incentives and staff effort; and limiting exclusion criteria. These practices may also enhance retention.

Duke Scholars

Author William Samuel Yancy Jr. Medicine, General Internal Medicine

Author Cynthia Jan Coffman Biostatistics & Bioinformatics, Division of Biostatistics

Author Eugene Zaverio Oddone Medicine, General Internal Medicine

Author Hayden Barry Bosworth Population Health Sciences