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

Abstract

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.

Introduction

A wealth of literature has shown that higher social support is associated with better adherence to health behaviors (e.g., diet, exercise) and emotional well-being, improved clinical outcomes, and lower mortality [1], [2]. In patients with chronic disease, social support could be marshaled to enhance self-management and, ultimately, patient outcomes [1], [3], [4]. To this end, spouses represent a potentially important source of social support [5].

One rationale for including spouses in health interventions is that they are the most common source of influence on people's health behaviors [6], [7]. Spouses may positively influence patients’ health by providing instrumental assistance (e.g., preparing healthier foods) or emotional support (e.g., empathy, positive reinforcement). Another rationale for couples-based interventions is that they could lead to improvements in several unique domains of quality of life, such as communication or satisfaction with the marital relationship. Finally, couples-based interventions may improve spouses’ physical or psychological health (“partner effect”) [8]; spouses with the same condition as patients may accrue direct health benefits, whereas spouses without the same condition may benefit from lifestyle changes (e.g., diet, exercise) or derive psychological benefits (e.g., less worry or stress) from helping their spouses achieve improved health status and outcomes.

Despite the potential benefits of couples-based interventions, conducting trials to evaluate them presents unique operational challenges. Consequently, recruitment rates typically range from 10 to 60%, with many in the 20 to 30% range (e.g. [9], [10], [11], [12], [13], [14]). In studies focusing on individual patients, such recruitment rates would be considered unsatisfactory in general.

In this paper, we describe our experience and lessons learned while recruiting participants into the CouPLES (Couples Partnering for Lipid-Enhancing Strategies) trial, which is evaluating the effectiveness of a couples-based intervention to help patients improve health behaviors, with the goal of lowering their non-fasting serum low-density lipoprotein cholesterol (LDL-C) levels. This ongoing trial is among the largest couples-based trials for chronic disease management to date.