Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Healthy Volunteers: f
View:

⁃ Adult caregivers will be eligible if they:

• Are English speaking.

• Have a child who is 1-10 years of age with SCD (any genotype) who has been prescribed hydroxyurea for at least 180 days prior to enrollment.

• Note: Caregivers who have multiple children meeting criteria will only be able to enroll once.

⁃ Adolescents (\>11 years at enrollment) are eligible if they:

• Are English speaking.

• Are 11-25 years of age.

• Have a diagnosis of SCD (any genotype) and have been prescribed hydroxyurea for at least 180 days prior to enrollment.

Locations
United States
Illinois
Lurie Children's Hospital
NOT_YET_RECRUITING
Chicago
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Rhode Island
Hasbro Children's Hospital
NOT_YET_RECRUITING
Providence
Contact Information
Primary
Susan Creary, MD, MSc
susan.creary@nationwidechildrens.org
(614) 722-3550
Backup
Nate Goldfarb, MPH
nate.goldfarb@nationwidechildrens.org
(614) 965-4948
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Video Directly Observed Therapy (VDOT)
Participants randomized to this arm will be connected with Scene Health by a study staff member (not the PI or Co-I's). After submitting and receiving approval of a test video submission, the participants' hydroxyurea dosing schedule will be entered into the VDOT app by the research staff and will be updated by these staff after their routine hematology visits and/or hospitalizations. Participants will receive VDOT for 180 days, beginning the day after randomization. After that time, they will start a 180-day ongoing monitoring period, during which VDOT participants will receive monthly telephone calls and intermittent text messages from Scene Health staff to encourage ongoing adherence. The Scene Health staff will access the electronic adherence platform and use this data to inform their communications during the ongoing monitoring period. Participants in both arms will be offered a smartphone with a data plan at enrollment to ensure equal opportunity for participation.
Other: Attention Control
Participants randomized to this arm will receive an automated, daily, short health or safety tip alert.
Sponsors
Collaborators: Hasbro Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Nationwide Children's Hospital

This content was sourced from clinicaltrials.gov