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Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study.


ABSTRACT: Background:Aims: The REAL HEALTH Diabetes Study is a practice-based randomized clinical trial that compares the effectiveness of lifestyle intervention aimed at weight reduction to medical nutrition therapy in primary care patients with type 2 diabetes. This paper describes a tiered approach to recruitment, the resultant enrollment rates of sequentially more intensive recruitment strategies, and identifies barriers to participation. Methods:Potential participants were identified using patient health registries and classified by recruitment site. Four recruitment strategies were used to achieve target enrollment: (1) mail/telephone outreach; (2) direct referral from providers; (3) orientation sessions; and (4) media/advertising. Reasons for ineligibility and non-participation were tracked. Results:Fifteen thousand two hundred sixty-nine (15,269) potential participants were identified from all sources, with the clear majority coming from patient registries. Mail/telephone outreach alone had the lowest enrollment rate (1.2%). Direct referral and orientation sessions superimposed on mail/telephone outreach was used for fewer participants but had greater enrollment rates (27% and 52%.) Media/advertising was ineffective. The most commonly reported reasons for non-participation were not wanting to be in a research (30%) or a weight loss program (22%); time commitment (20%); and distance/transportation (14%). Conclusions:The use of population registries to identify potential participants coupled with successively more intensive recruitment strategies, executed in a tiered approach moving toward personal engagement to establish trust and credibility, maximized recruitment enrollment rates. Our findings regarding facilitators and barriers to recruitment could be used to inform other practice-based research or to engage patients in group interventions in usual care settings. Clinical trial registration:NCT02320253.

SUBMITTER: Goldman V 

PROVIDER: S-EPMC6517530 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study.

Goldman Valerie V   Dushkin Amy A   Wexler Deborah J DJ   Chang Yuchiao Y   Porneala Bianca B   Bissett Laurie L   McCarthy Jeanna J   Rodriguez Anthony A   Chase Barbara B   LaRocca Rajani R   Wheeler Amy A   Delahanty Linda M LM  

Contemporary clinical trials communications 20190501


<h4>Background</h4>Aims: The REAL HEALTH Diabetes Study is a practice-based randomized clinical trial that compares the effectiveness of lifestyle intervention aimed at weight reduction to medical nutrition therapy in primary care patients with type 2 diabetes. This paper describes a tiered approach to recruitment, the resultant enrollment rates of sequentially more intensive recruitment strategies, and identifies barriers to participation.<h4>Methods</h4>Potential participants were identified u  ...[more]

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