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NCT05954000 · ClinicalTrials.gov registry record · Phase 1
Reducing African-American CVD Disparities Intervention Optimization (RADIO) Individuals on Statins
A Phase 1 study of Medication Adherence, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05954000: Completed Phase 1 study of Medication Adherence, sponsored by Northwell Health.
NCT05954000 is a Phase 1 study of Medication Adherence that has completed, run by Northwell Health. The registered enrollment target is 9 participants, below the 1,657-participant average among 52 other Medication Adherence trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05954000, a Phase 1 study of Medication Adherence, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Participant medication adherence increase will be assessed between run-in and follow-up periods using the smart pill bottle. A successful adherence increase is defined as average daily adherence to statin medications in the 2-week follow-up period being higher by 20% or more than in the 2-week run-in period. The minimum effective dose (MED) will be defined as the smallest BCT dose duration associated with 80% of participants receiving that dose having a successful statin adherence increase betwe
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 |
What the finished NCT05954000 record still lists
NCT05954000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,657-participant average among 52 other Medication Adherence trials with a reported enrollment target (99% lower).
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.
NCT05954000 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT05954000?
The interventions under investigation include: 5 Behavioral Change Techniques (BEHAVIORAL).
Who is sponsoring clinical trial NCT05954000?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05954000's enrollment target sits among peer trials
9 52nd of 52 higher than 1 of 52 other Medication Adherence trials
participants (enrollment target), bucketed by value
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