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HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health Related Quality of Life in Youth With Sickle Cell Disease

key information

source: The Journal of Pediatrics

year: 2018

authors: Arlene Smaldone, Sally Findley, Deepa Manwani, Haomiao Jia, Nancy S. Green

summary/abstract:

Objectives:
To examine the effect of a community health worker (CHW) intervention, augmented by tailored text messages, on adherence to hydroxyurea therapy in youths with sickle cell disease, as well as on generic and disease-specific health-related quality of life (HrQL) and youth-parent self-management responsibility concordance.

Study Design:
We conducted a 2-site randomized controlled feasibility study (Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment [HABIT]) with 2:1 intervention allocation. Youths and parents participated as dyads. Intervention dyads received CHW visits and text message reminders. Data were analyzed using descriptive statistics, the Wilcoxon signed-rank test, and growth models adjusting for group assignment, time, and multiple comparisons. Changes in outcomes from 0 to 6 months were compared with their respective minimal clinically important differences.

Results:
A total of 28 dyads (mean age of youths, 14.3 ± 2.6 years; 50% Hispanic) participated (18 in the intervention group, 10 in the control group), with 10.7% attrition. Accounting for group assignment, time, and multiple comparisons, at 6 months intervention youths reported improved generic HrQL total score (9.8 points; 95% CI, 0.4-19.2) and Emotions subscale score (15.0 points; 95% CI, 1.6-28.4); improved disease-specific subscale scores for Worry I (30.0 points; 95% CI, 8.5-51.5), Emotions (37.0 points, 95% CI, 9.4-64.5), and Communication I (17.8 points; 95% CI, 0.5-35.1); and 3-month dyad self-management responsibility concordance (3.5 points; 95% CI, -0.2 to 7.1). There were no differences in parent proxy-reported HrQL measures at 6 months.

Conclusions:
These findings add to research examining effects of behavioral interventions on HrQL outcomes in youths with sickle cell disease.

organization: Columbia University School of Nursing, USA; Columbia University Medical Center, USA; Mailman School of Public Health, USA; Albert Einstein College of Medicine, USA

DOI: 10.1016/j.jpeds.2018.01.054

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