RECRUITING

Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention. Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.

Official Title

Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

Quick Facts

Study Start:2024-07-11
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06264700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Susan Creary, MD, MSc
CONTACT
(614) 722-3550
susan.creary@nationwidechildrens.org
Nate Goldfarb, MPH
CONTACT
(614) 965-4948
nate.goldfarb@nationwidechildrens.org

Principal Investigator

Susan Creary, MD, MSc
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Lurie Children's Hospital
Chicago, Illinois, 60611
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Hasbro Children's Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

  • Susan Creary, MD, MSc, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-07-11
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Sickle Cell Disease
  • Hydroxyurea
  • Adherence

Additional Relevant MeSH Terms

  • Sickle Cell Disease