Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Nationwide Children's Hospital
Study ID
NCT06264700
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
11 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Video Directly Observed Therapy (VDOT) — BEHAVIORAL
    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.
  • Health Reminder Tip Alerts — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jul 11, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Retention Rate [ Time Frame: throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lurie Children's HospitalChicagoIllinois60611
Sherif Badawy, MD
[email protected]
312-227-4836
Nationwide Children's HospitalColumbusOhio43205
Susan Creary, MD, MSc
[email protected]
614-722-3563
Susan Creary, MD, MSc (PRINCIPAL_INVESTIGATOR)
Hasbro Children's HospitalProvidenceRhode Island02903
Patrick McGann, MD, PhD
[email protected]
617-519-9555

Find similar trials in Chicago, IL

By condition
Sickle cell disease
By research site
Lurie Children's Hospital· Chicago, ILNationwide Children's Hospital· Columbus, OHHasbro Children's Hospital· Providence, RI

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