A BCT Intervention for Medication Adherence Among Individuals on Statins

NCT05273736 | Completed Phase 1 DMC

• 2 other identifiers: 21-0707P30AG063786-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 participants 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.

Conditions

Medication Adherence

Keywords

Behavior Change; Medication Adherence; Physical Activity; Walking; Statin; Cardiovascular Disease; Dose Finding; Continual Reassessment Method

Outcome Measures

Primary Outcomes (1)

• Success or failure for change in Medication Adherence.

  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 between the run-in and the follow-up periods.

  Medication adherence will be assessed continuously via the smart pill bottle and adherence will be calculated daily. The change in proportion of days adherent will be compared between the run-in and follow-up periods (5-14 weeks from run-in).

Secondary Outcomes (7)

• Within-person change in Medication Adherence.

  Medication adherence will be assessed continuously via a smart pill bottle and adherence will be calculated daily. Change over time will be examined between the baseline, intervention, and follow-up periods (5-14 weeks from run-in).

• Within-person change in Self-Efficacy.

  Self-efficacy 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).

• Within-person change in Behavioral Automaticity.

  Behavioral automaticity 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).

• Within-person change in Discrepancy in Behavior.

  Feedback Processes 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).

• Within-person change in Motivation.

  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).

Other Outcomes (1)

• Between-person heterogeneity in Treatment Response.

  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).

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: 5 Behavioral Change Techniques

Interventions

5 Behavioral Change Techniques BEHAVIORAL

1. Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal to take your medication as prescribed tomorrow. 2. Action planning: prompt detailed planning of performance of behavior (must include a setting, frequency, duration, and intensity). Example: Develop a plan for taking your medication. 3. Self-Monitoring of behavior: establish a method for person to monitor and record their behavior. Example: Did you take your statin medication today? 4. Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You did not take your statin medication as prescribed yesterday. 5. Prompts/Cues: introduce or define environmental or social stimulus with the purpose of prompting or cueing the behavior. The prompt or cue would normally occur at the time or place of performance. Example: Please remember to take your medication soon.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 or older;
• Northwell Health employee/affiliate;
• Ambulatory without limitations: has never been advised by a clinician that increasing low-intensity walking would be unsafe;
• Prescribed statin medication;
• Self-reported low levels of adherence to statin medications;
• Access to and capable of using a smart cellular phone;
• After 2 week run-in, objectively-verified low levels of adherence to statin medications (\<60% of days using statin as prescribed) as documented by electronic pill bottles;
• English speaking.

You may not qualify if:

• Age less than 18 years;
• Not a Northwell Health employee/affiliate
• Non-ambulatory or unsafe/not recommended to participate in a walking program
• Not prescribed statin medication;
• Does not use or not willing to use Vivo Health as a pharmacy for prescription fills;
• History of CVD;
• Inability to comply with study protocol during 2 week run-in;
• Does not speak English;
• Unavailable for follow-up;
• Cognitive impairment;
• Severe mental illness (e.g., bipolar disorder or schizophrenia);
• Pregnancy

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Institute of Health System Science

New York, New York, 10022, United States

Location

Related Publications (1)

• Butler MJ, Romain AN, Augustin R, Robles P, Friel CP, Chandereng T, Suls JM, Vrany EA, Vicari F, Cheung YK, Davidson KW. The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol. Trials. 2023 Aug 12;24(1):523. doi: 10.1186/s13063-023-07549-w.

  PMID: 37573428 DERIVED

MeSH Terms

Conditions

Medication Adherence; Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Karina Davidson, PhD, MASc

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study utilizes a modified Time-To-Event Continual Reassessment Method Dose-Finding Design

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: March 10, 2022
• Study Start: July 21, 2022
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
• Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.

Locations

US (1)