Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC 27705, USA.
Patient Educ Couns. 2011 Jul;84(1):33-40. doi: 10.1016/j.pec.2010.06.005. Epub 2010 Jul 5.
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.
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.
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%.
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.
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.
利用配偶支持可能会提高慢性病管理干预措施的效果。然而，基于夫妻的干预措施存在后勤方面的挑战。我们描述了在招募夫妻参加“夫妻共同参与增强脂质策略”（CouPLES）试验时的经验和教训。
该试验旨在通过设计帮助患者参与自我管理行为的基于夫妻的干预措施，降低血清低密度脂蛋白胆固醇水平。我们计划在 13 个月内招募 250 对夫妻。
由于我们遇到的实际挑战，招募和登记工作持续了 21 个月。这些挑战包括：前往研究地点；有效地宣传研究；参与者负担；以及建立资格标准。通过修改方案来解决这些挑战，招募率从 12%提高到了 33%。
在没有确定最有效的招募策略的试验的情况下，研究人员可能需要进行试验，间歇性地修改方案，直到达到目标入组人数。我们提出的经验教训可能有助于进行基于夫妻的干预措施的研究人员制定更有效的方案。
为了达到目标入组人数，进行基于夫妻的干预措施的研究人员应考虑尽量减少前往研究地点的旅行；精心制作招募材料；为参与者激励和工作人员努力预算更多资金；并限制排除标准。这些做法也可能提高保留率。
