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Reducing African-American CVD Disparities Intervention Optimization (RADIO) Individuals on Statins
NCT05954000 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of medication adherence among Black and African American individuals on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Participants will complete a 2-week run-in period where medication adherence levels will be measured using a smart pill bottle and physical activity (PA) will be measured using Fitbit wearable devices. Then 42 participants will be randomized into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose. Assignment to doses will utilize a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) methodology to adjust the dose for each cohort based on the results from the previous cohort. After the intervention, there will be a 2-week follow-up period. The MED will be defined as the smallest BCT dose (defined by weeks of intervention) associated with 80% of participants having a 20% medication adherence increase between the run-in and the follow-up periods. The long-term goal is reduce incidence of CVD among Black and African American individuals by increasing adherence to primary prevention statin medications.
Conditions Studied
Interventions
- BEHAVIORAL 5 Behavioral Change Techniques
Study Locations (1)
New York
- Northwell Health — Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2024-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05954000
The ClinicalTrials.gov registry entry for NCT05954000 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 371 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Medication Adherence appearing as the primary indexed condition, and to 1 intervention — of which 5 Behavioral Change Techniques is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05954000 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05954000 about?
NCT05954000 is a clinical study titled "Reducing African-American CVD Disparities Intervention Optimization (RADIO) Individuals on Statins". The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of medication adherence among Black and African American individuals on primary prevention statin therapy who are at elevated risk for cardiovas...
What is the current status of trial NCT05954000?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2022-08-01. Estimated completion is 2024-01-20.
What conditions does trial NCT05954000 study?
This clinical trial studies the following conditions: Medication Adherence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05954000?
The interventions under investigation include: 5 Behavioral Change Techniques (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05954000?
This trial is sponsored by Northwell Health, which has 371 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05954000 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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