Adherence to multiple medications in the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) cohort: effect of additional medications on adherence to primary diabetes medication.

Background Non-adherence to diabetes medication leads to poor outcomes and increased healthcare costs. Multiple factors affecting adherence in adults with type 2 diabetes (T2D) have been identified, but pediatric data is sparse. We aimed to determine whether initiation of additional oral medications or insulin affects adherence to primary study medication (PSM) in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. Methods Six hundred and ninety-nine youth (aged 10-17 years) with recent-onset T2D were randomized in the TODAY study. Participants were categorized as adherent (≥80% taken by pill count) or non-adherent (<80%), and adherence was compared between those on additional medications or not. Subgroup analyses to assess influence of race/ethnicity, gender, medication type, or depression were performed. Results At 36 months, 46.3% of participants were taking additional oral medications and 31.9% were on insulin. There was no difference in study medication adherence with additional oral medications (55.1%, 67.1%, and 56.7% at month 36 in those prescribed 0, 1, or 2+ additional medications; p = 0.16). Girls on oral contraceptives (OC) had higher adherence (65.2% vs. 55.8% at month 36; p = 0.0054). Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001). There was decreased adherence in participants with baseline depression (p = 0.008). Conclusions Additional oral medications did not influence adherence to diabetes medications in TODAY. Addition of insulin led to reduced adherence. In subgroup analyses, OC use was associated with higher adherence in girls, while baseline depression was associated with lower adherence overall. Further studies examining potentially modifiable risk factors of adherence in pediatric T2D are needed.

Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium.

BACKGROUND: The recruitment of participants into community-based randomized controlled trials studying childhood obesity is often challenging, especially from low-income racial/ethnical minorities and when long-term participant commitments are required. This paper describes strategies used to recruit and enroll predominately low-income racial/ethnic minority parents and children into the Childhood Obesity Prevention and Treatment Research (COPTR) consortium. METHODS: The COPTR consortium has run four independent 3-year, multi-level (individual, family, school, clinic, and community) community-based randomized controlled trials. Two were prevention trials in preschool children and the other two were treatment trials in pre-adolescents and adolescent youth. All trials reported monthly participant recruitment numbers using a standardized method over the projected 18-24 months of recruitment. After randomization of participants was completed, recruitment staff and investigators from each trial retrospectively completed a survey of recruitment strategies and their perceived top three recruitment strategies and barriers. RESULTS: Recruitment was completed in 15-21 months across trials, enrolling a total of 1745 parent-child dyads- out of 6314 screened. The number of children screened per randomized child was 4.6 and 3.5 in the two prevention trials, and 3.1 and 2.5 in the two treatment trials. Recruitment strategies reported included: (1) careful planning, (2) working with trusting community partners, (3) hiring recruitment staff who were culturally sensitive, personality appropriate, and willing to work flexible hours, (4) contacting potential participants actively and repeatedly, (5) recruiting at times and locations convenient for participants, (6) providing incentives to participants to complete baseline measures, (7) using a tracking database, (8) evaluating whether participants understand the activities and expectations of the study, and (9) assessing participants' motivation for participating. Working with community partners, hiring culturally sensitive staff, and contacting potential participants repeatedly were cited by two trials among their top three strategies. The requirement of a 3-year commitment to the trial was cited by two trials to be among the top three recruitment barriers. CONCLUSIONS: Comprehensive strategies that include community partnership support, culturally sensitive recruitment staff, and repeated contacts with potential participants can result in successful recruitment of low-income racial/ethnic minority families into obesity prevention and treatment trials. TRIAL REGISTRATION: NET-Works trial: ClinicalTrials.gov, NCT01606891 . Registered on 28 May 2012. GROW trial: ClinicalTrials.gov, NCT01316653 . Registered on 16 March 2011. GOALS trial: ClinicalTrials.gov, NCT01642836 . Registered on 17 July 2012. IMPACT trial: ClinicalTrials.gov, NCT01514279 . Registered on 23 January 2012.

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

OBJECTIVE: To 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 METHODS: A 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. RESULTS: In 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. CONCLUSIONS: In 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.