Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 11, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Sickle Cell Disease
Interventions
BEHAVIORAL

Video Directly Observed Therapy (VDOT)

VDOT is an adherence-promoting intervention that involves partnering with an adolescent with SCD (or caregiver of a young patient with SCD) and observing the patient administer their hydroxyurea. In this study, VDOT will be delivered by a small business partner, Scene Health, via a smart phone app.

BEHAVIORAL

Health Reminder Tip Alerts

"Participants randomized to this arm will receive an automated, daily, short health or safety tip alert (e.g. Time to get moving! You should be active for at least 30 minutes each day) to receive during the 180-day intervention period on their smartphone. The daily tip will be unrelated to hydroxyurea adherence. After the 180-day intervention period, participants complete a 180-day ongoing monitoring period where they will no longer receive these messages, but they will be reminded to continue to use their electronic adherence monitoring device. All participants will be offered a smart phone with a data plan at enrollment to ensure equal opportunity for participation."

Trial Locations (3)

43205

RECRUITING

Nationwide Children's Hospital, Columbus

60611

NOT_YET_RECRUITING

Lurie Children's Hospital, Chicago

02903

NOT_YET_RECRUITING

Hasbro Children's Hospital, Providence

All Listed Sponsors
collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

collaborator

Hasbro Children's Hospital

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Nationwide Children's Hospital

OTHER