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

dc.contributor.author

Voils, Corrine I

dc.contributor.author

Yancy, William S

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Weinberger, Morris

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Bolton, Jamiyla

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Coffman, Cynthia J

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Jeffreys, Amy

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Oddone, Eugene Z

dc.contributor.author

Bosworth, Hayden B

dc.date.accessioned

2024-02-01T16:57:18Z

dc.date.available

2024-02-01T16:57:18Z

dc.date.issued

2011-07

dc.description.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.
dc.identifier

S0738-3991(10)00364-2

dc.identifier.issn

0738-3991

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1873-5134

dc.identifier.uri

https://hdl.handle.net/10161/30064

dc.language

eng

dc.publisher

Elsevier BV

dc.relation.ispartof

Patient education and counseling

dc.relation.isversionof

10.1016/j.pec.2010.06.005

dc.rights.uri

https://creativecommons.org/licenses/by-nc/4.0

dc.subject

Humans

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Self Care

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Family Characteristics

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Spouses

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Research Design

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Patient Selection

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Social Support

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Aged

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Middle Aged

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Female

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Male

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Cholesterol, LDL

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Randomized Controlled Trials as Topic

dc.title

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

dc.type

Journal article

duke.contributor.orcid

Coffman, Cynthia J|0000-0002-4554-1463

duke.contributor.orcid

Bosworth, Hayden B|0000-0001-6188-9825

pubs.begin-page

33

pubs.end-page

40

pubs.issue

1

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Duke

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School of Medicine

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Faculty

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Biostatistics & Bioinformatics

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Medicine

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Psychiatry & Behavioral Sciences

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Medicine, General Internal Medicine

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Duke Cancer Institute

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Duke Clinical Research Institute

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Institutes and Provost's Academic Units

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Center for the Study of Aging and Human Development

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Initiatives

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Duke Science & Society

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Population Health Sciences

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Duke Innovation & Entrepreneurship

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Psychiatry & Behavioral Sciences, Behavioral Medicine & Neurosciences

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Duke - Margolis Center For Health Policy

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Biostatistics & Bioinformatics, Division of Biostatistics

pubs.publication-status

Published

pubs.volume

84

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