Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03462511
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : December 12, 2022
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Arlene Smaldone, Columbia University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: HABIT Intervention Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Control Group

Dyads randomized to the control group will receive:

Standard care Education handouts.

 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.
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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean change in biomarker HbF [ Time Frame: 0 months, 6 months and 12 months ]
    Used to measure hydroxyurea adherence

  2. Mean change in proportion of days covered by hydroxyurea (using prescription refill data) [ Time Frame: Up to 12 months ]
    Used to measure hydroxyurea adherence


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03462511


Locations
Layout table for location information
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Columbia University Irving Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Columbia University
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Arlene Smaldone, PhD, CPNP-PC Columbia University School of Nursing
Principal Investigator: Nancy S Green, MD Columbia University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Arlene Smaldone, Professor of Nursing, Columbia University
ClinicalTrials.gov Identifier: NCT03462511    
Other Study ID Numbers: AAAR2908
1R01NR017206-01 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arlene Smaldone, Columbia University:
Hydroxyurea
Community health worker (CHW)
Text messages
Medication adherence
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn