Trial Outcomes & Findings for Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations (NCT NCT01651208)
NCT ID: NCT01651208
Last Updated: 2024-01-23
Results Overview
Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR\>=.80 to define the binary outcome of Appropriate Adherence
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
452 participants
Primary outcome timeframe
12 months after receiving coronary stent
Results posted on
2024-01-23
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing (MINT)
The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
|
Mailed DVD
A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
|
|---|---|---|
|
Overall Study
STARTED
|
227
|
225
|
|
Overall Study
COMPLETED
|
213
|
209
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
Reasons for withdrawal
| Measure |
Motivational Interviewing (MINT)
The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
|
Mailed DVD
A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
16
|
Baseline Characteristics
Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations
Baseline characteristics by cohort
| Measure |
Motivational Interviewing (MINT)
n=227 Participants
The MINT intervention will consist of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Contentedness, Self-Efficacy theory, and the Stages of Change model.
|
Mailed DVD
n=225 Participants
A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.11 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
69.94 years
STANDARD_DEVIATION 9.01 • n=7 Participants
|
69.52 years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
126 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Educational level
High School or Higher
|
51 participants
n=5 Participants
|
49 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Educational level
Less than High School
|
176 participants
n=5 Participants
|
176 participants
n=7 Participants
|
352 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after receiving coronary stentMedication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR\>=.80 to define the binary outcome of Appropriate Adherence
Outcome measures
| Measure |
Motivational Interviewing (MINT)
n=227 Participants
The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
|
Mailed DVD
n=225 Participants
A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
|
|---|---|---|
|
Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)
|
137 participants
|
105 participants
|
SECONDARY outcome
Timeframe: At 12 month post stent placementThe Morisky 4-Item Medication Adherence Scale (MMAS-4) is a self-reported measure of medication-taking behavior. Available in 33 languages, it addresses barriers to medication-taking. Each question can be answer as Yes or No for a range of 0-4 points.
Outcome measures
| Measure |
Motivational Interviewing (MINT)
n=227 Participants
The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
|
Mailed DVD
n=225 Participants
A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
|
|---|---|---|
|
4-Item Morisky Medication Adherence Scale (MMAS-4)
|
3.82 Score on a Scale
Standard Deviation .45
|
3.60 Score on a Scale
Standard Deviation .69
|
Adverse Events
Motivational Interviewing (MINT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed DVD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place