Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT (HABIT)
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|ClinicalTrials.gov Identifier: NCT02029742|
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : December 2, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Behavioral: Community Health Worker (CHW) Behavioral: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Community Health Worker Intervention
Community Health Workers will have scheduled interactions with subjects and will customize text messaging jointly with each youth and parent and initiate text message reminders to both parent and youth for months 4-6.
Behavioral: Community Health Worker (CHW)
CHWs will have scheduled interactions with subjects at home, by telephone or at Community League of the Heights (CLOTH), our partner community-based organization (CBO). CHWs will customize text messaging jointly with each youth and parent (Month 3) and text message reminders to both parent and youth will be implemented during Months 4-6. Subjects lacking a mobile phone or sufficient cell phone plan will be compensated to purchase or upgrade plans to accommodate texts.
Active Comparator: Education
Those randomized to the Education group will continue usual care, and will be provided with educational materials about sickle cell disease and hydroxyurea use for children.
Dyads randomized to the control group will continue usual clinic-based care, including monitoring and review of HbF levels, and similar frequency of clinic visits and access to sickle cell team staff. They will be provided with educational materials about sickle cell disease and hydroxyurea use for children.
- Effect size of the intervention on hydroxyurea (HU) adherence [ Time Frame: 6 months ]In this feasibility study, feasibility will be assessed of our methods, the impact of the intervention on adherence to hydroxyurea, and the ability to retain subjects throughout the 6 month period. These data will be used to calculate the effect size of the intervention to estimate the sample needed for a larger trial.
- Effect size of the intervention on youth-parent communication about self-management responsibility [ Time Frame: 6 months ]The investigators will estimate the effect size of the intervention on youth-parent communication about self-management responsibility by assessing quantitative changes in questionnaires administered to both parents and youth.
- Effect size of the intervention on youth-parent communication about quality of life (QOL) [ Time Frame: 6 months ]The investigators will estimate the effect size of the intervention on youth-parent communication about quality of life by assessing quantitative changes in in general pediatric and Sickle Cell disease Quality of Life questionnaires administered to both parents and youths.
- Effect size of the intervention on youth-parent communication about resource use [ Time Frame: 6 months ]The investigators will estimate the effect size of the intervention on youth-parent communication about resource use, such as urgent outpatient appointments, emergency room visits, hospitalizations, missed days from school and parent productivity by assessing quantitative changes in questionnaires administered to parents.
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|Ages Eligible for Study:||10 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Sickle type - homozygous sickle disease or sickle-beta thalassemia disease
- Age 10 to 18 years
- Currently prescribed hydroxyurea (HU) ≥18 months (for assessing historical hydroxyurea adherence and identify personal best)
- ≥3 fetal hemoglobin assessments over past 12 months with pre-HbF ≥10% below historical personal best value
- Youth has/uses cell phone with text message capability
- Youth able to speak/read English or Spanish.
- Youth willing to participate
- Parent/legal guardian meets all inclusion criteria
- Parent/guardian speaks/reads English or Spanish
- Parent/ legal guardian willing to participate
- Family expected to reside in community for ≥ 1 years
- A different sickle type
- Youth < 10 years of age or ≥ 18 years of age
- Youth not prescribed hydroxyurea, or on chronic transfusions
- <3 fetal hemoglobin assessments over past 12 months
- Sexually active female ≥11 not using reliable contraception (due to hydroxyurea teratogenic risk)
- Cognitive impairment (>1 level below expected grade)
- Youth not residing with parent/legal guardian
- Sibling of a youth enrolled in this study
- Parent/legal guardian is not the primary caregiver
- Youth in foster care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029742
|United States, New York|
|Montefiore Medical Center - Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Nancy Green, MD||Columbia University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Nancy Green, Professor of Pediatrics, Columbia University|
|Other Study ID Numbers:||
R21NR013745 ( U.S. NIH Grant/Contract )
|First Posted:||January 8, 2014 Key Record Dates|
|Last Update Posted:||December 2, 2017|
|Last Verified:||November 2017|
Sickle cell disease
Community health worker intervention
Sickle Cell Treatment
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn