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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
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Montefiore Medical Center
Information provided by (Responsible Party):
Nancy Green, Columbia University

Tracking Information
First Submitted Date  ICMJE January 6, 2014
First Posted Date  ICMJE January 8, 2014
Last Update Posted Date December 2, 2017
Study Start Date  ICMJE September 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
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 intervention, and our 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
Effect size of the intervention on youth-parent communication about self-management responsibility, quality of life (QOL) and resource use [ Time Frame: 6 months ]
Estimate the effect size of the intervention on youth-parent communication about self-management responsibility, quality of life (QOL) and resource use.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
Official Title  ICMJE Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
Brief Summary The investigators propose that culturally aligned community-based interventions in our multi-ethnic sickle cell disease (SCD) population, augmented by task-focused communication technology, can improve self-managed adherence to hydroxyurea (HU) by decreasing barriers to use, supporting parent-youth partnerships for chronic disease self-management and reinforcing the behavior of daily medication use. Culturally aligned community health workers (CHW) are a well-established means to support chronic disease self-management by underserved families, in partnership with medical homes. CHWs can identify and address multiple barriers and reinforce developmentally appropriate self-management to help youth reach and maintain their best fetal hemoglobin (HbF) levels. However, this strategy alone may be insufficient to achieve daily HU adherence. The investigators therefore propose a feasibility trial to test the feasibility and acceptability of a structured intervention of CHW support to address existing barriers to improve HU use, augmented by daily cue-based parent and youth text message reminders, to efficiently extend CHW family support and reinforce family partnerships for self-management.
Detailed Description Sickle cell disease (SCD) is an inherited disorder affecting the blood and causes anemia, painful sickle crises, organ damage, reduced quality of life and high health care use. Hydroxyurea (HU) is an oral medication that reduces disease symptoms and improves quality of life by increasing the amount of fetal hemoglobin in the blood. Despite the clinical promise of hydroxyurea, many children with SCD do make taking hydroxyurea a daily health habit. General barriers to medication adherence in underserved populations include lack of trust of medical staff, incomplete knowledge regarding benefits of hydroxyurea, and other factors that impede access to care such as transportation difficulties. Challenges specific to hydroxyurea use include understanding the importance of maximizing fetal hemoglobin levels and addressing concerns about hydroxyurea. Children and adolescents also require that a developmentally appropriate transition of self-management be established with their parents. Community-based health workers are a well established means to provide support for chronic disease management for underserved families and address multi-faceted barriers through culturally, behaviorally and developmentally aligned intervention. The investigators hypothesize that Community Health Workers support, augmented by daily task-focused communication technology, can improve self-managed adherence to hydroxyurea.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • 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.
  • Behavioral: Education
    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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Community Health Worker (CHW)
  • 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.
    Intervention: Behavioral: Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Youth:

  1. Sickle type - homozygous sickle disease or sickle-beta thalassemia disease
  2. Age 10 to 18 years
  3. Currently prescribed hydroxyurea (HU) ≥18 months (for assessing historical hydroxyurea adherence and identify personal best)
  4. ≥3 fetal hemoglobin assessments over past 12 months with pre-HbF ≥10% below historical personal best value
  5. Youth has/uses cell phone with text message capability
  6. Youth able to speak/read English or Spanish.
  7. Youth willing to participate

Parent:

  1. Parent/legal guardian meets all inclusion criteria
  2. Parent/guardian speaks/reads English or Spanish
  3. Parent/ legal guardian willing to participate
  4. Family expected to reside in community for ≥ 1 years

Exclusion Criteria:

Youth:

  1. A different sickle type
  2. Youth < 10 years of age or ≥ 18 years of age
  3. Youth not prescribed hydroxyurea, or on chronic transfusions
  4. <3 fetal hemoglobin assessments over past 12 months
  5. Sexually active female ≥11 not using reliable contraception (due to hydroxyurea teratogenic risk)
  6. Pregnancy
  7. Cognitive impairment (>1 level below expected grade)
  8. Youth not residing with parent/legal guardian
  9. Sibling of a youth enrolled in this study

Parent:

  1. Parent/legal guardian is not the primary caregiver
  2. Youth in foster care
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02029742
Other Study ID Numbers  ICMJE AAAJ7350
R21NR013745 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nancy Green, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • National Institute of Nursing Research (NINR)
  • Montefiore Medical Center
Investigators  ICMJE
Principal Investigator: Nancy Green, MD Columbia University
PRS Account Columbia University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP