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Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial

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ClinicalTrials.gov Identifier: NCT03462511
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Arlene Smaldone, Columbia University

Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE September 10, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • Mean change in biomarker HbF [ Time Frame: 0 months, 6 months and 12 months ]
    Used to measure hydroxyurea adherence
  • Mean change in proportion of days covered by hydroxyurea (using prescription refill data) [ Time Frame: Up to 12 months ]
    Used to measure hydroxyurea adherence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • Mean change in score on Peds Quality of Life (generic quality of life) [ Time Frame: 0 months, 6 months and 12 months ]
    Used to measure health-related quality of life
  • Mean change in score on PedsQL Sickle Cell Disease module (disease specific quality of life) [ Time Frame: 0 months, 6 months and 12 months ]
    Used to measure health-related quality of life
  • Mean change in score on Sickle Cell Family Responsibility instrument [ Time Frame: 0 months, 6 months and 12 months ]
    Used to measure parent/youth concordance regarding delegation of self-management responsibility by mean change in dyad concordance
Original Secondary Outcome Measures  ICMJE Same as current
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 Disease (HABIT): Efficacy Trial
Official Title  ICMJE Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial
Brief Summary Many youth with chronic disease have difficulty taking medication every day and therefore do not receive full benefit from treatment. Sickle Cell Disease (SCD) is an inherited blood disease that affects African Americans and other underserved communities. Hydroxyurea (HU) is the sole FDA-approved drug therapy for SCD and is highly effective and improves quality of life. The proposed study, a 5-site four-year randomized control trial (RCT), builds upon the investigators' recent feasibility study of the same title. Overall goals are reducing barriers to HU use and improving adherence for youth 10-18 years through creation of a daily medication habit. The goal of the proposed multi-site study is to test the efficacy of the HABIT intervention at 6 months and sustainability of the effect at 12 months.
Detailed Description

Barriers to medication adherence are common in youth with chronic illness and are a source of racial/ethnic disparities in underserved communities. An inherited blood disease, Sickle Cell Disease (SCD) is characterized by chronic and acute illness and reduced quality of life (QOL). It affects African Americans and other underserved communities. Hydroxyurea (HU) is the sole FDA-approved drug therapy for SCD and is highly effective and improves QOL. Poor adherence is common among youth and young adults with SCD.

The importance of poor medication adherence, use of community-based health workers (CHWs) to bridge the gap between health services and underserved parent-youth dyads affected by SCD, the strength of the science, the success of the investigators' multi-ethnic feasibility study, and the potential application of study findings to youth with other serious chronic illnesses speak to the importance of this trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Behavioral: HABIT Intervention
In addition to standard care and education handouts, dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.
Study Arms  ICMJE
  • No Intervention: Control Group
    Dyads randomized to the control group will receive standard care and education handouts.
  • Experimental: Intervention Group
    In addition to standard care and education handouts, dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.
    Intervention: Behavioral: HABIT Intervention
Publications * Smaldone A, Manwani D, Aygun B, Smith-Whitley K, Jia H, Bruzzese JM, Findley S, Massei J, Green NS. HABIT efficacy and sustainability trial, a multi-center randomized controlled trial to improve hydroxyurea adherence in youth with sickle cell disease: a study protocol. BMC Pediatr. 2019 Oct 15;19(1):354. doi: 10.1186/s12887-019-1746-6.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2018)
208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria - Youth:

  • One of the two most common sickle cell disease variants (HbSS or HbS-B0 thalassemia)
  • Age 10 through18 years (inclusive)
  • Currently prescribed hydroxyurea (HU) ≥18 months (for identifying historical Personal best HbF)
  • Current HU dose is within 5% of dose at Personal Best HbF
  • Pre-enrollment HbF ≥15% below historical Personal best, based on mean of ≥2 HbF assessments over preceding 12 months
  • Youth able to speak/read English or Spanish

Inclusion Criteria - Parent:

  • Parent/guardian speaks/reads English or Spanish
  • Parent/ legal guardian willing to participate
  • Family expects to reside in community for ≥ 1.5 years

Exclusion Criteria - Youth:

  • Youth not prescribed HU
  • <2 HbF assessments over past 12 months
  • Transfusion within 3 months preceding enrollment
  • Final screen HbF (visit 0) of ≤15% decrease below Personal best HbF
  • Sexually active female 10 years or older and not using reliable contraception (due to HU teratogenic risk)
  • Pregnancy
  • Cognitive impairment (>2 levels below expected grade)
  • Youth not residing with parent/legal guardian

Exclusion Criteria - Parent:

  • Parent/legal guardian does not reside with youth
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: Arlene Smaldone, PhD, CPNP-PC 212 342 3048 ams130@columbia.edu
Contact: Nancy S Green, MD 212 305 0494 nsg11@columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462511
Other Study ID Numbers  ICMJE AAAR2908
1R01NR017206-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arlene Smaldone, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Arlene Smaldone, PhD, CPNP-PC Columbia University School of Nursing
Principal Investigator: Nancy S Green, MD Columbia University
PRS Account Columbia University
Verification Date July 2019

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