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

NCT ID: NCT05954000

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-01-20

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 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.

Detailed Description

The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change technique (BCT) intervention required to increase statin medication adherence among Black and African American individuals on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The long-term goal is to prevent CVD among Black and African American individuals. The current project will utilize a modified version of the time-to-event continual reassessment method (TiTE-CRM), a state of the art dose finding methodology, to determine the MED of a multi-component BCT intervention required to increase the proportion of days adherent to statin medications by 20%. 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.

The study sample will include individuals who identify as Black or African American and are currently prescribed primary prevention statin therapy. For this research, the investigators will enroll participants with low levels of self-reported adherence to statin medications, with the goal of randomizing 42 persons to the intervention. Enrolled participants will complete a 2-week run-in period where levels of adherence to statin medications will be assessed using a smart pill bottle and physical activity levels will be measured using a Fitbit wearable device. During the run-in period, data from the smart pill bottle will be used to verify objective non-adherence to statin medications (defined as taking statin medications as prescribed for less than 80% of days). Individuals who do not meet objective levels of nonadherence to statin medications and/or are non-adherent to the protocol will be excluded and will not be randomized to the intervention. Following the run-in, the investigators will randomize 42 participants 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 of a multi-BCT intervention. Assignment to doses will utilize modified TiTE-CRM methodology to adjust the dose for each cohort based on the results from the previous cohort. Following the intervention, all participants will be assessed over a 2-week follow-up period which includes passive data collection from the activity monitor, answering surveys and use of the electronic pill bottle to track medication adherence. The MED will be defined as the smallest BCT dose duration associated with a 20% increase in the proportion of days using statin medication as prescribed between the run-in and the follow-up periods in 80% of the sample receiving that dose. Adherence to statins will be defined using changes in weight of medication in the smart pill bottle. The investigators will also assess Mechanisms of Action (MoAs) to determine potential mediators of the BCT intervention on physical activity (PA). As some evidence suggests there are correlations between adherence and PA and that interventions targeting medication adherence also influence PA, the investigators will utilize Fitbit devices to determine whether the BCT intervention increase participant's levels of activity.

Conditions

Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

5 Behavioral Change Techniques

Intervention Type: 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.

Interventions

5 Behavioral Change Techniques

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Identifies as Black/African American
• Aged ≥ 18 years
• Speaks English
• Has a self-report of low adherence to statin medication
• Prescribed statin medication
• Owns and can regularly access a smartphone capable of receiving text messages and accessing the internet
• Ambulatory without limitations (has never been advised by a clinician that increasing low-intensity walking would be unsafe)

Exclusion Criteria

• History of CVD
• Does not speak English
• Does not own or cannot regularly access a smartphone capable of receiving text messages
• Inability to comply with study protocol during a 2-week run-in period
• Unavailable for follow-up
• Cognitive impairment; severe mental illness (e.g., bipolar disorder or schizophrenia)
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Toronto Dominion Bank

UNKNOWN

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J Butler, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health

Manhasset, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

21-1192

Identifier Type: -

Identifier Source: org_study_id