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Behavioral Intervention

Behavioral Change Techniques for Medication Adherence

Phase 1

Waitlist Available

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

Must not have

Age less than 18 years

Does not use or not willing to use Vivo Health as a pharmacy for prescription fills

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

No Placebo-Only Group

Summary

This trial aims to find the smallest effective dose of a behavioral program that helps people at risk for heart disease take their statin medication regularly. The program includes setting goals, planning, self-monitoring, feedback, and reminders. The study will measure how well participants stick to their medication schedule using smart pill bottles and activity trackers.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I do not use and am not willing to use Vivo Health for my prescriptions.

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I have a history of cardiovascular disease.

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I cannot walk or it's unsafe for me to join a walking program.

Timeline

Screening ~ 3 weeks3 visits

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).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Success or failure for change in Medication Adherence.

Secondary study objectives

Within-person change in Behavioral Automaticity.

Within-person change in Daily Steps.

Within-person change in Discrepancy in Behavior.

+4 more

Other study objectives

Phenotypic Variation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~100

0 / 8Eligibility criteria met