Challenging Recruitment of Youth With Type 2 Diabetes Into Clinical Trials

Nguyen, Tammy; Jayadeva, Vikas; Cizza, Giovanni; Brown, Rebecca; Nandagopal, R.; Rodríguez, Luisa M.; Rother, Kristina I.

doi:10.1016/j.jadohealth.2013.08.017

Cited by 51 publications

(81 citation statements)

References 43 publications

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“…There is some evidence for great difficulty in recruiting youth for any type of diabetes-related intervention, especially among minorities. 40,41 …”

Section: Discussionmentioning

confidence: 99%

Patient Perspectives on Peer Mentoring

et al. 2014

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Purpose The purpose of the study was to identify attitudes and topics relevant to peer mentoring as an adherence-promoting intervention for adolescents and young adults (YAs) with type 1 diabetes (T1D). Methods Self-administered survey data were collected in two diabetes clinics from a convenience sample of adolescents as prospective mentees (ages 13–18) and YAs as prospective mentors (ages 19–25) with T1D. Survey topics included demographics, disease history, glycemic control, adherence, depression, barriers to disease management, social support, and interest in peer mentoring. Descriptive statistical analyses, thematic coding, and stepwise multivariate logistic regression were performed. Results A majority of the 54 adolescents and 46 YAs expressed interest in a peer mentoring program. Having supportive friends and living in a large household positively predicted adolescent interest in having a peer mentor. Approximately one third of all participants experienced social barriers to diabetes management. For adolescents, barriers included inflexible schedules, unfamiliar foods, and the embarrassment of checking blood glucose in front of others. Young adults reported barriers in tracking food consumption and remembering to check blood glucose. Various diabetes management skills were in high demand by adolescents, who especially desired to learn about managing T1D on their own and in college. Participants were open to multiple communication modes, including in-person meetings, phone, text messaging, and social media. Conclusions Many adolescents and young adults with T1D are interested in peer mentoring as a way to facilitate learning and sharing essential diabetes management skills and experiences.

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“…There is some evidence for great difficulty in recruiting youth for any type of diabetes-related intervention, especially among minorities. 40,41 …”

Section: Discussionmentioning

confidence: 99%

Patient Perspectives on Peer Mentoring

et al. 2014

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“…Two additional studies with younger participants also found preferences for e-technologies. In a study of youth with Type 2 diabetes, Nguyen and colleagues (2014) found that monetary incentives and technological approaches (mobile phones and websites) were the most effective strategies to engage and retain participants. In contrast, patients with rheumatoid arthritis, with a mean age of 61 years, preferred to complete research surveys via regular mail, followed by telephone, with the Internet identified as their least preferred method (Garcia et al, 2014).…”

Section: 0 Integrating E-technologies Into Clinical Trial Design Imentioning

confidence: 99%

Using e-technologies in clinical trials

Rosa

Campbell

Miele

et al. 2015

Contemporary Clinical Trials

135

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Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.

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“…There is a dearth of information in the literature regarding adherence to medication in pediatric patients with type 2 diabetes. One report (10) from a study of youth with type 2 diabetes at three clinical sites concluded that “compliance with medications and doctor’s appointments is suboptimal in youth with type 2 diabetes.” The objective of the current analysis was to identify factors that predicted medication adherence and to examine relationships among adherence, glycemic control, and indices of insulin action in the TODAY cohort.…”

Section: Introductionmentioning

confidence: 99%

Correlates of Medication Adherence in the TODAY Cohort of Youth With Type 2 Diabetes

et al. 2016

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OBJECTIVETo identify factors that predict medication adherence and to examine relationships among adherence, glycemic control, and indices of insulin action in TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth).RESEARCH DESIGN AND METHODSA total of 699 youth 10–17 years old with recent-onset type 2 diabetes and ≥80% adherence to metformin therapy for ≥8 weeks during a run-in period were randomized to receive one of three treatments. Participants took two study pills twice daily. Adherence was calculated by pill count from blister packs returned at visits. High adherence was defined as taking ≥80% of medication; low adherence was defined as taking <80% of medication. Depressive symptoms, insulin sensitivity (1/fasting insulin), insulinogenic index, and oral disposition index (oDI) were measured. Survival analysis examined the relationship between medication adherence and loss of glycemic control. Generalized linear mixed models analyzed trends in adherence over time.RESULTSIn this low socioeconomic cohort, high and low adherence did not differ by sex, age, family income, parental education, or treatment group. Adherence declined over time (72% high adherence at 2 months, 56% adherence at 48 months, P < 0.0001). A greater percentage of participants with low adherence had clinically significant depressive symptoms at baseline (18% vs. 12%, P = 0.0415). No adherence threshold predicted the loss of glycemic control. Longitudinally, participants with high adherence had significantly greater insulin sensitivity and oDI than those with low adherence.CONCLUSIONSIn the cohort, the presence of baseline clinically significant depressive symptoms was associated with subsequent lower adherence. Medication adherence was positively associated with insulin sensitivity and oDI, but, because of disease progression, adherence did not predict long-term treatment success.

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Challenging Recruitment of Youth With Type 2 Diabetes Into Clinical Trials

Cited by 51 publications

References 43 publications

Patient Perspectives on Peer Mentoring

Patient Perspectives on Peer Mentoring

Using e-technologies in clinical trials

Correlates of Medication Adherence in the TODAY Cohort of Youth With Type 2 Diabetes

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