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

NCT03462511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-06-26

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

HABIT Intervention

Dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.

OTHER

Standard of Care

Standard of care used to treat patients with SCD

OTHER

Education materials

Education materials provided to all patients enrolled in the trial

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Arlene Smaldone, PhD, CPNP-PC · Columbia University School of Nursing

  • Nancy S Green, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462511 on ClinicalTrials.gov