Project Details
Description
Summary/Abstract:
Sickle cell disease (SCD) is a severe inherited blood disorder that leads to frequent acute and costly long-term
complications. Hydroxyurea is the primary SCD modifying medication in childhood because studies show that it
can reduce acute complications and mitigate costly long-term comorbidities. Hydroxyurea non-adherence is
common, however, and a key reason for the limited impact that it has had on the outcomes of youth in clinical
practice. Despite the impact that improving hydroxyurea adherence among children and adolescents could
have on reducing SCD burden, studies testing adherence-promoting interventions for youth are lacking. Video
directly observed therapy (VDOT) is an electronic hydroxyurea adherence-promoting strategy delivered using
smartphones and includes reminder alerts, video directly observed therapy by trained observers, encouraging
adherence feedback from the observers, and monetary incentives for achieving adherence goals. VDOT has
been tested in a single-arm study and showed promising results. Yet, attrition was higher than anticipated due
to some dissatisfaction with the previous email platform that was used to deliver VDOT and many participants
having inconsistent personal smartphone and cellular data access. Engagement with VDOT was not
thoroughly assessed, even though the degree of engagement with VDOT has potential to moderate the impact
of the intervention. Aspects of the previous study, including the method used to measure adherence and the
non-randomized design also limited the ability to definitively conclude that VDOT improves adherence. Finally,
the adherence decline that was observed after VDOT was discontinued without any additional adherence
support suggested that additional monitoring and intervention after intensive VDOT may be needed to promote
lasting adherence behavior change. This feedback and experience prompted us to partner with emocha
Health. This is a small business that has a user-friendly VDOT platform, experience successfully providing
VDOT to other chronically ill populations, and an established system to provide intermittent ongoing adherence
to support after VDOT to limit attrition, optimize participant engagement, and sustain adherence. Therefore, the
primary objective of this proposal is to assess retention and sustained engagement during a pilot RCT
comparing VDOT via the emocha Health platform to attention control. We will also explore adolescents’ and
caregivers’ needs and preferences for longer-term adherence monitoring and intervention. This application
aligns with NHLBI’s goal to optimize therapeutic strategies for SCD as it improving adherence is critically
relevant to support life-long healthy behaviors and improve outcomes of these youth.
Status | Active |
---|---|
Effective start/end date | 09/15/23 → 08/31/24 |
Funding
- National Heart, Lung, and Blood Institute: $642,844.00
Fingerprint
Explore the research topics touched on by this project. These labels are generated based on the underlying awards/grants. Together they form a unique fingerprint.