Abstract
The purpose of this study is to describe recruitment and retention experiences from three behavioral randomized controlled trials conducted among youth with type 1 diabetes. Eligibility, recruitment, and retention data were examined. Study-specific differential study participation and loss-to-follow-up analyses assessed the relations of patient characteristics with treatment completion and 6-month retention. Multivariable logistic regression identified factors independently associated with 6-month retention among all participants. Approximately 70–92 % of randomized participants completed treatment and 58–90 % were retained for follow-up. Older patients and non-Caucasian patients were less likely to enroll. Treatment completion and 6-month retention were less likely among youth who were older, had worse baseline glycemic control, lower household income, and/or unmarried parents. Some subgroups of patients are less likely to participate in research and are more susceptible to loss-to-follow-up. More work is needed to understand the facilitators and barriers to research participation.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Boys, A., Marsden, J., Stillwell, G., Hatchings, K., Griffiths, P., & Farrell, M. (2003). Minimizing respondent attrition in longitudinal research: Practical implications from a cohort study of adolescent drinking. Journal of Adolescence, 26, 363–373. doi:10.1016/S0140-1971%2803%2900011-3.
Coday, M., Boutin-Foster, C., Sher, T. G., Tennant, J., Greaney, M. L., & Saunders, S. D. (2005). Strategies for retaining study participants in behavioral intervention trials: Retention experiences of the NIH Behavior Change Consortium. Annals of Behavior Medicine, 29, 55–65. doi:10.1207/s15324796abm2902s_9.
Flores, G., Bridon, C., Torres, S., Perez, R., Walter, T., Brotanek, J., … & Tomany-Korman, S. (2009). Improving asthma outcomes in minority children: A randomized, controlled trial of parent mentors. Pediatrics, 124(6), 1522–1532. doi:10.1542/peds.2009-0230.
Germann, J. N., Kirschenbaum, D. S., & Rich, B. H. (2006). Use of an orientation session may help decrease attrition in a pediatric weight management program for low-income minority adolescents. Journal of Clinical Psychology in Medical Settings, 13(2), 177–187.
Grey, M., Jaser, S. S., Whittemore, R., Jeon, S., & Lindemann, E. (2011). Coping skills training for parents of children with type 1 diabetes: 12-month outcomes. Nursing Research, 60(3), 173–181. doi:10.1097/NNR.0b013e3182159c8f.
Gul, R. B., & Ali, P. A. (2010). Clinical trials: The challenge of recruitment and retention of participants. Journal of Clinical Nursing, 19, 227–233. doi:10.1111/j.1365-2702.2009.03041.x.
Harris, P. M. (1998). Attrition revisited. American Journal of Evaluation, 19(3), 293–305. doi:10.1016/S1098-2140(99)80213-6.
Herbert, L., Monaghan, M., Cogen, F., & Streisand, R. (2014). The impact of parents’ sleep quality and hypoglycemia worry on diabetes self-efficacy. Behavioral Sleep Medicine, 16, 1–16.
Holmes, C., Chen, R., Mackey, E., Grey, M., & Streisand, R. (2014). Randomized clinical trial of clinic-integrated, low-intensity treatment to prevent deterioration of disease care in adolescents with type 1 diabetes. Diabetes Care, 37(6), 1535–1543.
Kamps, J. L., Rapoff, M. A., Roberts, M. C., Varela, R. E., Barnard, M., & Olson, N. (2008). Improving adherence to inhaled corticosteroids in children with asthma: A pilot of a randomized clinical trial. Children’s Health Care, 37, 261–277. doi:10.1080/02739610802437335.
Kane, R. L., Wang, J., & Garrard, J. (2007). Reporting in randomized clinical trials improved after adoption of the CONSORT statement. Journal of Clinical Epidemiology, 60, 241–249. doi:10.1016/j.jclinepi.2006.06.016.
Karlson, C. W., & Rapoff, M. A. (2009). Attrition in randomized controlled trials for pediatric chronic conditions. Journal of Pediatric Psychology, 34(7), 782–793. doi:10.1093/jpepsy/jsn122.
Keith, S. J. (2001). Evaluating characteristics of patient selection and dropout rates. Journal of Clinical Psychiatry, 62, 11–14.
Krishna, S., Balas, E. A., Francisco, B. D., & Konig, P. (2006). Effective and sustainable multimedia asthma education program: A randomized trial. Children’s Health Care, 35, 75–90. doi:10.1207/s15326888chc3501_7.
Loding, R. N., Wold, J. E., Skavhaug, A., & Graue, M. (2009). Evaluation of peer-group support and problem-solving training in the treatment of adolescents with type 1 diabetes. European Diabetes Nursing, 4(1), 28–33. doi:10.1002/edn.73.
Marcellus, L. (2004). Are we missing anything? Pursuing research on attrition. Canadian Journal of Nursing Research, 36, 82098.
Meldrum, M. L. (2000). A brief history of the randomized clinical trial: From oranges and lemons to the gold standard. Hematology/Oncology Clinics of North America, 14(4), 745–760. doi:10.1016/S0889-8588(05)70309-9.
Monaghan, M., Younge, T., McCarter, R., Cogen, F., & Streisand, R. (2014). Use of Average Daily Risk Range (ADRR) in young children with type 1 diabetes. Journal of Diabetes Science and Technology, 8(1), 70–73.
Patel, M. X., Doku, V., & Tennakoon, T. (2003). Challenges in recruitment of research participants. Advances in Psychiatric Treatment, 9, 229–238. doi:10.1192/apt.9.3.229.
Probstfield, J. L., & Frye, R. L. (2011). Strategies for recruitment and retention of participants in clinical trials. Journal of the American Medical Association, 306(16), 1798–1799. doi:10.1001/jama.2011.1544.
Rhee, H., Ciurzynski, S. M., & Yoos, H. L. (2008). Pearls and pitfalls of community-based group interventions for adolescents: Lessons learned from an adolescent asthma camp study. Issues in Comprehensive Pediatric Nursing, 31, 122–135. doi:10.1080/01460860802272888.
Stark, L., Janicke, D. M., McGrath, A. M., Mackner, L. M., Hommel, K. A., & Lovell, D. (2005). Prevention of osteoporosis: A randomized clinical trial to increase calcium intake in children with juvenile rheumatoid arthritis. Journal of Pediatric Psychology, 30, 377–386. doi:10.1093/jpepsy/jsi061.
Stehl, M. L., Kazak, A. E., Alderfer, M. A., Rodriguez, A., Hwang, W., & Pai, A. L. H. (2009). Conducting a randomized clinical trial of a psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. Journal of Pediatric Psychology, 34(8), 803–816. doi:10.1093/jpepsy/jsn130.
Streisand, R., & Mednick, L. (2006). Development of the Diabetes Education, Counseling, Information Delivery and Evaluation (DECIDE) Program: A health promotion intervention for preadolescents with Type 1 Diabetes. Journal of Clinical Psychology in Medical Settings, 13(2), 180–190.
Sullivan-Bolyai, S., Bova, C., Leung, K., Trudeau, A., Lee, M., & Gruppuso, P. (2010). Social Support to Empower Parents (STEP): An intervention for parents of young children newly diagnosed with type 1 diabetes. Diabetes Educator, 36(1), 88–97. doi:10.1177/0145721709352384.
Tercyak, K. P., Donze, J. R., Prahlad, S., Mosher, R. B., & Shad, A. T. (2006). Identifying, recruiting, and enrolling adolescent survivors of childhood cancer into a randomized controlled trial of health promotion: Preliminary experiences in the Survivor Health and Resilience Education (SHARE) Program. Journal of Pediatric Psychology, 31(3), 252–261. doi:10.1093/jpepsy/jsj013.
Wakim, P. G., Rosa, C., Kothari, P., & Michel, M. E. (2011). Relation of study design to recruitment and retention in CTN trials. The American Journal of Drug and Alcohol Abuse, 37, 426–433. doi:10.3109/00952990.2011.596972.
Wysocki, T., Harris, M. A., Buckloh, L. M., Mertlich, D., Lochrie, A. S., & Taylor, A. (2006). Effects of behavioral family systems therapy for diabetes on adolescents’ family relationships, treatment adherence, and metabolic control. Journal of Pediatric Psychology, 31(9), 928–938. doi:10.1093/jpepsy/jsj098.
Acknowledgments
The authors wish to thank Carrie Miller, Victoria Owen, and Rachel Sweenie for their assistance with data review. This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (Grant Numbers R01DK080102, DK062161, R01DK070917).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of Interest
Linda J. Herbert, Catherine Gillespie, Maureen Monaghan, Clarissa Holmes, and Randi Streisand declare that they have no conflict of interest.
Human and Animal Rights and Informed Consent
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation of Children’s National Health System and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for being included in the study.
Rights and permissions
About this article
Cite this article
Herbert, L.J., Gillespie, C., Monaghan, M. et al. Factors Associated with Recruitment and Retention in Randomized Controlled Trials of Behavioral Interventions for Patients with Pediatric Type 1 Diabetes. J Clin Psychol Med Settings 23, 112–125 (2016). https://doi.org/10.1007/s10880-015-9448-1
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10880-015-9448-1