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%.


CONCLUSIONS
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.


CONCLUSIONS
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.
Voils
Corrine I
CI
Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA. voils001@mc.duke.edu
Yancy
William S
WS
Weinberger
Morris
M
Bolton
Jamiyla
J
Coffman
Cynthia J
CJ
Jeffreys
Amy
A
Oddone
Eugene Z
EZ
Bosworth
Hayden B
HB
D000368:Aged; D008078:Cholesterol, LDL / Q000097:blood*; D005191:Family Characteristics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012648:Self Care; D012944:Social Support; D018454:Spouses
D008078:Cholesterol, LDL