Ontology highlight
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

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]