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Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT (HABIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Community Health Worker (CHW) Behavioral: Education Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Columbia University
National Institute of Nursing Research (NINR)
Montefiore Medical Center
Investigators
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Principal Investigator: Nancy Green, MD Columbia University
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nancy Green, Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT02029742    
Other Study ID Numbers: AAAJ7350
R21NR013745 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Keywords provided by Nancy Green, Columbia University:
Sickle cell disease
Medication adherence
Hydroxyurea
Community health worker intervention
Sickle Cell Treatment
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn