Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

Summary

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.

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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• Hasbro Children's Hospital

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Nationwide Children's Hospital

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-11

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• United States

Study Locations