TY - JOUR
T1 - Rationale and protocol for a cluster randomized, cross-over trial of recruitment methods of rural children in primary care clinics
T2 - A feasibility study of a pediatric weight control trial in the IDeA States Pediatric Clinical Trials Network
AU - Davis, Ann M.
AU - Darden, Paul M.
AU - Snowden, Jessica
AU - Simon, Alan E.
AU - McCulloh, Russell J.
AU - Bimali, Milan
AU - Lee, Jeannette
N1 - Funding Information:
Research reported in this publication was supported by the National Institutes of Health , Office of the Director to the IDeA States Pediatric Clinical Trials Network under award number U24 OD024957 to University of Arkansas for Medical Sciences , UG1 OD024943 to University of Kansas Medical Center , UG1 OD024950 to University of Oklahoma Health Sciences Center , and UG1 OD024953 to University of Nebraska Medical Center . The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/8
Y1 - 2021/8
N2 - A significant percentage of clinical trials fail due to poor recruitment. Despite this, few studies exist to evaluate clinical trial recruitment strategies using a randomized approach in any population, and none exist to test recruitment strategies for trials involving children or rural populations. For clinical trials focused on weight control, evaluating retention and dose are extremely important, as poor retention can lead to biased samples and existing research shows that dose (i.e. contact hours) is directly related to patient outcome. Finally, adequacy of blinding of assessment teams is rarely reported in pediatric trials, and unblinded staff may be more likely to inadvertently bias findings. Therefore, in this feasibility trial we aim to use rigorous clinical trial methodology to assess the effectiveness of two different recruitment strategies, as well as test retention, dose, and blinding. Specifically, we describe the rationale, design, and planned implementation of a feasibility study of a rural pediatric obesity treatment trial that will be implemented in four medical clinics in four states affiliated with the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN). The primary objective is to assess recruitment rate for consecutive recruitment (approaching recently seen eligible patients in consecutive order by date seen) compared to traditional recruitment (such as posters, flyers, tear-offs), as well as to assess retention, dose, and blinding. If successful, this trial will support the implementation of a large multi-state trial directed at addressing obesity in rural children and their families recruited from their primary care clinics. Registered with ClinicalTrials.gov NCT ID NCT04142034.
AB - A significant percentage of clinical trials fail due to poor recruitment. Despite this, few studies exist to evaluate clinical trial recruitment strategies using a randomized approach in any population, and none exist to test recruitment strategies for trials involving children or rural populations. For clinical trials focused on weight control, evaluating retention and dose are extremely important, as poor retention can lead to biased samples and existing research shows that dose (i.e. contact hours) is directly related to patient outcome. Finally, adequacy of blinding of assessment teams is rarely reported in pediatric trials, and unblinded staff may be more likely to inadvertently bias findings. Therefore, in this feasibility trial we aim to use rigorous clinical trial methodology to assess the effectiveness of two different recruitment strategies, as well as test retention, dose, and blinding. Specifically, we describe the rationale, design, and planned implementation of a feasibility study of a rural pediatric obesity treatment trial that will be implemented in four medical clinics in four states affiliated with the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN). The primary objective is to assess recruitment rate for consecutive recruitment (approaching recently seen eligible patients in consecutive order by date seen) compared to traditional recruitment (such as posters, flyers, tear-offs), as well as to assess retention, dose, and blinding. If successful, this trial will support the implementation of a large multi-state trial directed at addressing obesity in rural children and their families recruited from their primary care clinics. Registered with ClinicalTrials.gov NCT ID NCT04142034.
KW - Blinding
KW - Clinics
KW - Dose
KW - Environmental influences on child health outcomes IDeA States Pediatric Clinical Trial Network (ECHO ISPCTN)
KW - Pediatric obesity
KW - Recruitment
KW - Retention
KW - Rural
KW - mHealth
UR - http://www.scopus.com/inward/record.url?scp=85109703931&partnerID=8YFLogxK
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U2 - 10.1016/j.cct.2021.106476
DO - 10.1016/j.cct.2021.106476
M3 - Article
C2 - 34118426
AN - SCOPUS:85109703931
VL - 107
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
M1 - 106476
ER -