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Behavioural Intervention

Behavioral Techniques for Medication Adherence (RADIO Trial)

Phase 1

Waitlist Available

Led By Mark J Butler, PhD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up motivation will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).

Awards & highlights

RADIO Trial Summary

This trial is studying how to improve adherence to statin medications in Black/African American individuals at risk for CVD, using different doses of 5 behavior change techniques.

Who is the study for?

The RADIO trial is for Black/African American individuals aged 18 or older who speak English, have been prescribed statin medication but report low adherence to it. They must own a smartphone and be able to walk without limitations. People with a history of CVD, severe mental illness, pregnancy, cognitive impairments, or those unable to follow the study protocol are excluded.Check my eligibility

What is being tested?

This trial tests how effective different doses of a behavioral change intervention are in improving statin medication adherence among participants at risk for CVD. The intervention includes Goal Setting, Action Planning, Self-Monitoring, Feedback & Prompts/Cues over varying lengths from 1-10 weeks determined by previous cohort results.See study design

What are the potential side effects?

Since this trial focuses on behavioral techniques rather than medications or invasive procedures, side effects may include discomfort with technology use (smart pill bottles and Fitbit devices), privacy concerns regarding health monitoring data and potential stress related to adhering to the intervention protocols.

RADIO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ motivation will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~motivation will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in).

This trial's timeline: 3 weeks for screening, Varies for treatment, and motivation will be assessed at the completion of baseline and will be assessed every 2 weeks until the end of the follow-up period (5-14 weeks from run-in). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Success or failure for change in Medication Adherence.

Secondary outcome measures

Within-person change in Behavioral Automaticity.

Within-person change in Daily Steps.

Within-person change in Discrepancy in Behavior.

+4 more

RADIO Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Dose-finding study with 14 groups of 3 participants each. To identify the minimum effective dose (MED) to increase medication adherence by 20% between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 1 and 10 weeks in length and will be determined by the modified Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous subjects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5 Behavioral Change Techniques

2022

Completed Phase 1

~60

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Toronto Dominion BankUNKNOWN

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,924 Total Patients Enrolled

Mark J Butler, PhDPrincipal InvestigatorNorthwell Health

Media Library

5 Behavioral Change Techniques (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05954000 — Phase 1

Medication Adherence Research Study Groups: Intervention

Medication Adherence Clinical Trial 2023: 5 Behavioral Change Techniques Highlights & Side Effects. Trial Name: NCT05954000 — Phase 1

5 Behavioral Change Techniques (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05954000 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this Intervention received regulatory authorization from the FDA?

"Our team at Power has allocated a score of 1 to Intervention's safety because this is an initial trial, with limited data available concerning its efficacy and security."

Answered by AI

What is the aggregate figure of participants in this trial?

"Affirmative, according to clinicaltrials.gov this medical study is actively looking for participants. It was originally published on January 1st 2022 and recently revised on July 12th 2023 with the goal of recruiting 42 patients from a single site."

Answered by AI

Is recruitment underway for this experiment?

"Confirmed. The clinicaltrials.gov website states that the trial is currently recruiting, which was first advertised on January 1st 2022 and updated most recently on July 12th 2023. This investigation requires 42 volunteers from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing African-American CVD Disparities Intervention Optimization (RADIO) Individuals on Statins

2022. "Reducing African-American CVD Disparities Intervention Optimization (RADIO) Individuals on Statins". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05954000.