PURPOSE: Treatment adherence rates are below 50% across chronic medical conditions, including cystic fibrosis (CF). We are conducting a national, clustered, randomized controlled trial to improve adherence in adolescents with CF (I Change Adherence and Raise Expectations; iCARE). CF Centers are randomized to a behavioral intervention (Comprehensive Adherence Program; CAP) or Standard Care (SC). CAP includes assessment and remediation of gaps in knowledge of disease management and treatment skills, followed by problem-solving (PS) sessions to address individual barriers to adherence. The primary aim is to evaluate the effectiveness of CAP versus SC on medication adherence measured by pharmacy refills.
METHODS: CF Centers (N=18) in the US were randomized to CAP or SC in Year 1. Sites randomized to CAP continue to implement the intervention in Year 2 in a generalization phase. Sites randomized to the SC transition to CAP in Year 2. Knowledge of Disease Management, observed treatment skills, and health-related quality of life (CFQ-R; Quittner et al., 2005) are measured at Baseline, 12 and 24 months.
RESULTS: 634 participants with CF, ages 11 to 20 were recruited. Baseline assessments have been completed by 81% of the sample to date. Adolescents were, on average, 14.5 years old (SD=2.6), 44.7% male, and had mild disease severity (MFEV1 =85.2%; SD=22.1). Adolescents’ knowledge scores were highest on the Lung Health Scale (M=85.1%, SD=14.3) and lowest on the Nutrition Scale (M=68.8%; SD=15.5). Adolescents demonstrated the best skills in taking enzymes (n= 439; M=94.2%; SD=12.4) and the worst skills on acapella (n=118; M=67.6; SD=22.8). PS treatment fidelity, assessed with a variety of interventionists (e.g., MD, nurse, social worker), ranged from 0 to 8 on an 8-point scale (n=153; M=5.5, SD=1.5).
CONCLUSIONS: Preliminary results suggest that adolescents have significant gaps in knowledge of disease management and treatment skills.
CLINICAL IMPLICATIONS: PS can be learned by healthcare providers and used in both outpatient clinics and hospitals. Future directions include evaluating the effects of CAP on adherence to prescription refills.
DISCLOSURE: Alexandra Quittner: Grant monies (from sources other than industry): NIH SBIR and R01 grants, Grant monies (from industry related sources): Investigator-initiated grant for behavioral study, Consultant fee, speaker bureau, advisory committee, etc.: North American Scientific Advisory Group, Consultant fee, speaker bureau, advisory committee, etc.: Gilead Sciences, Vertex, Bayer
Cara Kimberg: Consultant fee, speaker bureau, advisory committee, etc.: Gilead Sciences
Kristen Marciel: Consultant fee, speaker bureau, advisory committee, etc.: Gilead Sciences, Grant monies (from industry related sources): Urand
Kristin Riekert: Grant monies (from industry related sources): Investigator-initiated grant, Consultant fee, speaker bureau, advisory committee, etc.: Novartis, Other: Grant from a foundation
The following authors have nothing to disclose: Jie Zhang
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