Trial Outcomes & Findings for Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes (NCT NCT00399880)
NCT ID: NCT00399880
Last Updated: 2017-09-25
Results Overview
Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
Approximately 2 weeks after hospital discharge
Results posted on
2017-09-25
Participant Flow
Participant milestones
| Measure |
Health Literacy Intervention
Illustrated medication schedules, pill boxes, pharmacist counseling
Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling
|
Usual Care
Usual care arm
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
Baseline characteristics by cohort
| Measure |
Health Literacy Intervention
n=65 Participants
Illustrated medication schedules, pill boxes, pharmacist counseling
Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling
|
Usual Care
n=65 Participants
Usual care arm
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
52.2 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
52.4 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Income
<$10,000
|
40 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Income
$10,000-$20,000
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Income
>$20,000
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Income
Missing
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Employment status
Unemployed
|
31 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Employment status
Full-time
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Employment status
Part-time
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Employment status
Other (disabled, retired)
|
24 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Employment status
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education
|
11.6 years
STANDARD_DEVIATION 3.0 • n=99 Participants
|
11.5 years
STANDARD_DEVIATION 2.9 • n=107 Participants
|
11.6 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Rapid Estimate of Adult Literacy in Medicine (REALM)
|
41.1 units on a scale
STANDARD_DEVIATION 21.7 • n=99 Participants
|
39.1 units on a scale
STANDARD_DEVIATION 22.7 • n=107 Participants
|
40.1 units on a scale
STANDARD_DEVIATION 22.1 • n=206 Participants
|
|
Smoking status
Never
|
18 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Smoking status
Former
|
14 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Smoking status
Current
|
33 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Smoking status
Missing
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 weeks after hospital dischargePopulation: Participants who were able to be contacted and provided outcome data.
Validated self-report measure of medication adherence. Possible range 12-48, with lower values indicating better adherence.
Outcome measures
| Measure |
Health Literacy Intervention
n=38 Participants
Illustrated medication schedules, pill boxes, pharmacist counseling
Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling
|
Usual Care
n=38 Participants
Usual care arm
|
|---|---|---|
|
Adherence to Refills and Medications Scale (ARMS)
|
12.03 units on a scale
Standard Deviation 2.59
|
12.18 units on a scale
Standard Deviation 3.81
|
SECONDARY outcome
Timeframe: Approximately 2 weeks after hospital dischargePopulation: Participants who were able to be contacted and provided outcome data.
Validated measure of confidence in taking medications correctly. Possible range 13-39, with higher values indicating greater confidence.
Outcome measures
| Measure |
Health Literacy Intervention
n=39 Participants
Illustrated medication schedules, pill boxes, pharmacist counseling
Health literacy intervention: Illustrated medication schedules, pill boxes, pharmacist counseling
|
Usual Care
n=42 Participants
Usual care arm
|
|---|---|---|
|
Self-Efficacy for Appropriate Medication Use Scale (SEAMS)
|
32.8 units on a scale
Standard Deviation 4.8
|
31.5 units on a scale
Standard Deviation 6.7
|
Adverse Events
Health Literacy Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Kathryn Goggins, Research Coordinator
Vanderbilt University Medical Center
Phone: 6159364819
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place