InterventionThe trials and tribulations of enrolling couples in a randomized, controlled trial: A self-management program for hyperlipidemia as a model☆
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.
Section snippets
Design
The design and methods of the CouPLES trial have been reported in detail elsewhere [15]. To summarize, eligibility was determined in a three-step process (described in more detail in Section 3.4), then eligible couples were randomized to the control or intervention arm. Patients in the control arm receive usual care from their physician with no contact from study personnel to the patient or spouse except for two subsequent outcome assessment visits. Patients and spouses in the intervention arm
Challenges and solutions
Researchers conducting couples-based interventions may encounter a number of practical challenges related to identifying eligible couples, attempting to enroll them, and retaining both members of each couple in the trial. Below, we summarize the recruitment challenges we encountered, the protocol amendments we made in attempt to improve the recruitment rate, and our impression of which changes positively affected the recruitment rate. Fig. 3 provides a detailed timeline with recruitment
Discussion
Given the wealth of literature showing the potential beneficial effect of the social context on health behaviors, and given our lack of understanding about the best way to intervene in spousal support interventions [1], [4], more couples-based studies are needed. These studies present significant logistical challenges, underscoring the need to identify effective recruitment and retention strategies. We were unable to determine the distinct impact of each amendment because several amendments
Acknowledgments
This research is supported by a grant from the Department of Veterans Affairs (DVA) Health Services Research and Development (HSR&D) service (IIR 05-273, PI: Voils). Dr. Yancy was supported by a Career Development Award from DVA HSR&D (RCD 02-183). Dr. Weinberger is supported by a Career Scientist Award from DVA HSR&D (RCS 91-408). Dr. Bosworth is supported by a Career Scientist Award from DVA HSR&D (08-027). The views expressed in this article are those of the authors and do not necessarily
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Spousal support in a behavior change intervention for cholesterol management
2013, Patient Education and CounselingCitation Excerpt :Eligible couples were scheduled for in-person baseline assessments where they provided written consent, completed self-report measures, and received education materials; they were then randomized to intervention or usual care. Details of the intervention have been reported [15,16]. The lifestyle coaching intervention, couples partnering for lipid enhancing strategies (CouPLES), was designed to help patients adopt health behaviors important for LDL-C control with support from their spouses and the intervention nurse.
A randomized controlled trial to evaluate the effectiveness of CouPLES: A spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol
2013, Preventive MedicineCitation Excerpt :In this two-group, randomized, controlled trial (Fig. 1), couples in both groups received educational handouts containing guideline-concordant recommendations (2001) and providing spousal support; provided baseline measurements; and then were randomized to usual care or the intervention. Eligibility was determined in a 3-step process (see Voils et al., 2009, 2011 for more details). In Step 1, electronic medical records were used to identify patients who were married, one or more LDL-C ≥ 100 mg/dL, and one or more primary care visits in the previous 12 months.
Inviting patients and care partners to read doctors' notes: OpenNotes and shared access to electronic medical records
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The ClinicalTrials.gov registration number is NCT00321789.