Trial Outcomes & Findings for The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness (NCT NCT05098743)
NCT ID: NCT05098743
Last Updated: 2024-08-19
Results Overview
The ARMS is a global (continuous) 12-item scale, responses range from 1 (none) to 4 (all of the time) with a possible score of 12-48, patients with low ARMS scores indicate better adherence, it is valid and reliable in a low-literacy chronic disease population.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Baseline to 30 days.
Results posted on
2024-08-19
Participant Flow
Participants were recruited from a healthcare center, as noted in the protocol section.
Participant milestones
| Measure |
Participants Using the Medication Adherence Mobile Application.
Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.
Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
|
Participants Using a Printed Copy of Their Medication List.
Participants in this arm will use a printed out copy of their medication list for thirty days.
Printed medication list: Patients will receive a printed out medication list from their electronic medical record.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Participants Using the Medication Adherence Mobile Application.
Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.
Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
|
Participants Using a Printed Copy of Their Medication List.
Participants in this arm will use a printed out copy of their medication list for thirty days.
Printed medication list: Patients will receive a printed out medication list from their electronic medical record.
|
|---|---|---|
|
Overall Study
One participant had no data because they were unable to download the app despite multiple attempts
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness
Baseline characteristics by cohort
| Measure |
Participants Using the Medication Adherence Mobile Application.
n=30 Participants
Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.
Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
|
Participants Using a Printed Copy of Their Medication List.
n=31 Participants
Participants in this arm will use a printed out copy of their medication list for thirty days.
Printed medication list: Patients will receive a printed out medication list from their electronic medical record.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
53.50 years
n=5 Participants
|
51 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chose not to respond
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
ARMS
|
18.5 units on a scale
n=5 Participants
|
17.0 units on a scale
n=7 Participants
|
18.0 units on a scale
n=5 Participants
|
|
SEAMS
|
29.0 units on a scale
n=5 Participants
|
31.0 units on a scale
n=7 Participants
|
29.0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 days.The ARMS is a global (continuous) 12-item scale, responses range from 1 (none) to 4 (all of the time) with a possible score of 12-48, patients with low ARMS scores indicate better adherence, it is valid and reliable in a low-literacy chronic disease population.
Outcome measures
| Measure |
Participants Using the Medication Adherence Mobile Application.
n=30 Participants
Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.
Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
|
Participants Using a Printed Copy of Their Medication List.
n=31 Participants
Participants in this arm will use a printed out copy of their medication list for thirty days.
Printed medication list: Patients will receive a printed out medication list from their electronic medical record.
|
|---|---|---|
|
Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS)
|
-4.0 score on a scale
Interval -8.0 to -1.0
|
-1.0 score on a scale
Interval -3.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline to 30 days.The SEAMS is a global (continuous) 13-item scale, responses range from 1 (not confident) to 3 (very confident), with a possible score of 13-39. Patients with higher scores indicate higher levels of self-efficacy for medication adherence. It is valid and reliable in low-literacy chronic disease populations. Patients are asked their level of confidence about taking medications correctly.
Outcome measures
| Measure |
Participants Using the Medication Adherence Mobile Application.
n=30 Participants
Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.
Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
|
Participants Using a Printed Copy of Their Medication List.
n=31 Participants
Participants in this arm will use a printed out copy of their medication list for thirty days.
Printed medication list: Patients will receive a printed out medication list from their electronic medical record.
|
|---|---|---|
|
Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS)
|
3.5 score on a scale
Interval 0.0 to 8.0
|
0.0 score on a scale
Interval -3.0 to 3.0
|
Adverse Events
Participants Using the Medication Adherence Mobile Application.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participants Using a Printed Copy of Their Medication List.
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