Clinical trial NCT05954000: Reducing African-American CVD Disparities Intervention Optimization (RADIO) Individuals on Statins
Official title: Reducing African-American CVD Disparities Intervention Optimization (RADIO) Program: A Dose Finding Pilot Study Protocol and Focus Group Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Medication Adherence
Keywords: medication
adherence
dose finding
personalized
digital
TiTE-CRM
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Toronto Dominion Bank
First posted: 2023-07-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study utilizes a modified Time-To-Event Continual Reassessment Method Dose-Finding Design
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Success or failure for change in Medication Adherence.
timeFrame: 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:
measure: Within-person change in Medication Adherence.
timeFrame: 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).
measure: Within-person change in Self-Efficacy.
timeFrame: 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).
measure: Within-person change in Behavioral Automaticity.
timeFrame: 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)
measure: Within-person change in Discrepancy in Behavior.
timeFrame: 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).
measure: Within-person change in Environmental Context and Resources.
timeFrame: Environmental Context and Resources 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).
measure: Within-person change in Motivation.
timeFrame: 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).
measure: Within-person change in Daily Steps.
timeFrame: Steps will be assessed continuously via worn activity tracker and step counts will be calculated daily. Change over time will be examined between the baseline, intervention, and follow-up periods (5-14 weeks from run-in)
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Northwell Health
name: Mark J Butler, PhD
role: PRINCIPAL_INVESTIGATOR
References: