Trial Outcomes & Findings for Increasing Adherence to Treatment Recommendations Following a Cardiac Event (NCT NCT02327260)
NCT ID: NCT02327260
Last Updated: 2019-04-12
Results Overview
Whether participants attend an orientation session at TMC's CR program
COMPLETED
NA
61 participants
Within 2 months of study enrollment
2019-04-12
Participant Flow
Patients were recruited for the study between March 2015 and May 2016. Patients were approached for study inclusion during hospitalization following a cardiac procedure.
Participant milestones
| Measure |
Video + MI for CR
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
This is the standard of care group. It received typical care by hospital staff following a cardiac procedure.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
24
|
17
|
|
Overall Study
COMPLETED
|
14
|
20
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
2
|
Reasons for withdrawal
| Measure |
Video + MI for CR
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
This is the standard of care group. It received typical care by hospital staff following a cardiac procedure.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
2
|
|
Overall Study
invalid phone number
|
1
|
1
|
0
|
|
Overall Study
non-adherence to protocol
|
2
|
0
|
0
|
|
Overall Study
cognitive concerns
|
1
|
0
|
0
|
Baseline Characteristics
Increasing Adherence to Treatment Recommendations Following a Cardiac Event
Baseline characteristics by cohort
| Measure |
Video + MI for CR
n=14 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=20 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=15 Participants
This group received standard care following a cardiac procedure.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.50 years
STANDARD_DEVIATION 8.71 • n=99 Participants
|
57.50 years
STANDARD_DEVIATION 7.96 • n=107 Participants
|
55.93 years
STANDARD_DEVIATION 7.06 • n=206 Participants
|
56.45 years
STANDARD_DEVIATION 7.81 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
20 participants
n=107 Participants
|
15 participants
n=206 Participants
|
49 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Within 2 months of study enrollmentWhether participants attend an orientation session at TMC's CR program
Outcome measures
| Measure |
Video + MI for CR
n=14 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=20 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=15 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Participation in CR
|
7 Participants
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Collected at 5 weeks post-dischargePopulation: Some pharmacies did not respond to us after repeated requests for participants' data; therefore, data are missing.
A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.
Outcome measures
| Measure |
Video + MI for CR
n=12 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=15 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=9 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Adherence (Ratio): P2Y12 Platelet Inhibitor
|
.47 adherence ratio
Standard Deviation .44
|
.72 adherence ratio
Standard Deviation .44
|
.46 adherence ratio
Standard Deviation .46
|
PRIMARY outcome
Timeframe: Collected at 5 weeks post-dischargePopulation: We are missing data because some pharmacies did not respond to our requests.
A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.
Outcome measures
| Measure |
Video + MI for CR
n=12 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=15 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=9 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Adherence (Ratio): Beta-Blocker
|
.20 adherence ratio
Standard Deviation .36
|
.39 adherence ratio
Standard Deviation .49
|
.40 adherence ratio
Standard Deviation .48
|
PRIMARY outcome
Timeframe: Collected at 5 weeks post-dischargePopulation: We are missing data because some pharmacies did not respond to our requests.
A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.
Outcome measures
| Measure |
Video + MI for CR
n=12 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=15 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=9 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Adherence (Ratio): Statin
|
.22 adherence ratio
Standard Deviation .44
|
.37 adherence ratio
Standard Deviation .48
|
.46 adherence ratio
Standard Deviation .45
|
PRIMARY outcome
Timeframe: Collected at 5 weeks post-dischargePopulation: We are missing some data because pharmacies did not respond to our requests.
A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.
Outcome measures
| Measure |
Video + MI for CR
n=12 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=15 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=9 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Adherence (Ratio): Angiotensin System Blocker
|
.26 adherence ratio
Standard Deviation .43
|
.44 adherence ratio
Standard Deviation .53
|
.91 adherence ratio
Standard Deviation .13
|
PRIMARY outcome
Timeframe: Interview data at 5 weeks post-dischargeParticipants were asked how many times they filled P2Y12 Platelet Inhibitors since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.
Outcome measures
| Measure |
Video + MI for CR
n=14 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=20 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=15 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Number of Participants With Self-reported Medication Adherence: P2Y12 Platelet Inhibitor
|
9 Participants
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Interview data at 5 weeks post-dischargeParticipants were asked how many times they filled Beta-Blockers since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.
Outcome measures
| Measure |
Video + MI for CR
n=14 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=20 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=15 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Number of Participants With Self-reported Medication Adherence: Beta-Blocker
|
10 Participants
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Interview data at 5 weeks post-dischargeParticipants were asked how many times they filled Statins since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.
Outcome measures
| Measure |
Video + MI for CR
n=14 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=20 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=15 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Number of Participants With Self-reported Medication Adherence: Statin
|
10 Participants
|
9 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Interview data at 5 weeks post-dischargeParticipants were asked how many times they filled Angiotensin System Blockers since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.
Outcome measures
| Measure |
Video + MI for CR
n=14 Participants
This group receives the educational video and an MI session for CR participation.
Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
|
MI for Medication Adherence
n=20 Participants
This group receives an MI session for taking prescribed cardioprotective medications,
Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
|
Control Group (Standard Care)
n=15 Participants
This group received standard care following a cardiac procedure.
|
|---|---|---|---|
|
Number of Participants With Self-reported Medication Adherence: Angiotensin System Blocker
|
11 Participants
|
11 Participants
|
7 Participants
|
Adverse Events
Video + MI for CR
MI for Medication Adherence
Control Group (Standard Care)
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