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Behavioral Intervention

Behavioral Change Techniques for Medication Adherence

Phase 1
Recruiting
Led By Karina Davidson, PhD, MASc
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prescribed statin medication
Access to and capable of using a smart cellular phone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up medication adherence will be assessed continuously via smart pill bottle and adherence will be reported daily. statin adherence will be averaged during the 2-weeks of run-in and by 2-week blocks until the end of the follow-up period (5-14 weeks).
Awards & highlights

Study Summary

This trial is testing whether a behavior change intervention can increase medication adherence among people at risk for cardiovascular disease. The intervention will vary in length from 1-10 weeks, and the minimum effective dose will be the length of intervention associated with 80% of participants having a 20% increase in medication adherence.

Who is the study for?
This trial is for Northwell Health employees or affiliates over 18 who have low adherence to statin medications, can use a smart phone, and are able to walk without limitations. They must not have cardiovascular disease, severe mental illness, cognitive impairments, or be pregnant.Check my eligibility
What is being tested?
The study tests a behavioral intervention using Goal Setting, Action Planning, Self-Monitoring, Feedback & Prompts/Cues to improve medication adherence in participants on statins. It uses smart pill bottles and Fitbits during a variable-length program determined by previous cohort results.See study design
What are the potential side effects?
Since the interventions are non-pharmacological behavior change techniques rather than drugs or medical procedures, they do not carry traditional side effects. However, participants may experience stress or frustration if they struggle with technology used in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently taking statin medication.
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I can use a smartphone.
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I have taken my statin medication less than 60% of the prescribed days.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~medication adherence will be assessed continuously via smart pill bottle and adherence will be reported daily. statin adherence will be averaged during the 2-weeks of run-in and by 2-week blocks until the end of the follow-up period (5-14 weeks).
This trial's timeline: 3 weeks for screening, Varies for treatment, and medication adherence will be assessed continuously via smart pill bottle and adherence will be reported daily. statin adherence will be averaged during the 2-weeks of run-in and by 2-week blocks until the end of the follow-up period (5-14 weeks). 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
Other outcome measures
Phenotypic Variation

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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,891 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,659 Previous Clinical Trials
28,004,727 Total Patients Enrolled
Karina Davidson, PhD, MAScPrincipal InvestigatorNorthwell Health
6 Previous Clinical Trials
594 Total Patients Enrolled

Media Library

5 Behavioral Change Techniques (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05273736 — Phase 1
Medication Adherence Research Study Groups: Intervention
Medication Adherence Clinical Trial 2023: 5 Behavioral Change Techniques Highlights & Side Effects. Trial Name: NCT05273736 — Phase 1
5 Behavioral Change Techniques (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05273736 — Phase 1

Frequently Asked Questions

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

Are the 5 Behavioral Change Techniques validated by the FDA?

"The safety of the 5 Behavioral Change Techniques is rated as a 1 due to the limited data collected in this Phase 1 trial, which does not offer substantial evidence for either efficacy or security."

Answered by AI

What is the current scope of this investigation in terms of those receiving treatment?

"Affirmative. The information accessible via clinicaltrials.gov reveals that this study is presently looking for suitable applicants, with the investigation having been first made public on July 21st 2022 and most recently modified on September 6th 2022. 42 participants must be recruited from a single site to complete the trial."

Answered by AI

Is this medical experiment currently seeking new participants?

"Indeed, clinicaltrials.gov reveals that this trial has been open since July 21st 2022 and is actively recruiting 42 patients from one location. This data was last updated on September 6th of the same year."

Answered by AI
~2 spots leftby Apr 2024