Trial Outcomes & Findings for Mobile Application for Prescription Drug-Abuse Education (MAPDE) (NCT NCT03165175)
NCT ID: NCT03165175
Last Updated: 2019-08-05
Results Overview
Mean COMM scale score as an indicator of risk for opioid prescription drug misuse. It measures 17 misuse behaviors over the past 30 days for those currently taking medications. Scores can range from 0-4 with higher scores indicating a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline and 1 month
Results posted on
2019-08-05
Participant Flow
Participant milestones
| Measure |
App + Treatment as Usual
The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. The educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.
As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
|
Treatment as Usual
The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
|
|---|---|---|
|
1-month to 3-month
STARTED
|
41
|
39
|
|
1-month to 3-month
COMPLETED
|
35
|
39
|
|
1-month to 3-month
NOT COMPLETED
|
6
|
0
|
|
Baseline to 3-month
STARTED
|
35
|
39
|
|
Baseline to 3-month
COMPLETED
|
31
|
39
|
|
Baseline to 3-month
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Application for Prescription Drug-Abuse Education (MAPDE)
Baseline characteristics by cohort
| Measure |
App + Treatment as Usual
n=41 Participants
The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.
As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
|
Treatment as Usual
n=39 Participants
The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
39 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Branch of Service
Navy
|
31 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Branch of Service
Marine Corps
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Education
less than high school
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education
Finished high school
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Education
Finished high school and some college
|
36 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Deployment History
Ever Deployed
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Deployment History
Never Deployed
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 monthMean COMM scale score as an indicator of risk for opioid prescription drug misuse. It measures 17 misuse behaviors over the past 30 days for those currently taking medications. Scores can range from 0-4 with higher scores indicating a worse outcome.
Outcome measures
| Measure |
App + Treatment as Usual
n=35 Participants
The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.
As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
|
Treatment as Usual
n=39 Participants
The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
|
|---|---|---|
|
Current Opioid Misuse Measure (COMM)
Baseline mean
|
.72 score on a scale
Standard Deviation .37
|
.71 score on a scale
Standard Deviation .49
|
|
Current Opioid Misuse Measure (COMM)
1 month mean
|
.62 score on a scale
Standard Deviation .47
|
.63 score on a scale
Standard Deviation .40
|
SECONDARY outcome
Timeframe: Baseline and 1 monthMean PMQ scale score as an indicator of prescription drug misuse. This 5-item scale was adapted from a brief scale previously used by Morasco and Dobscha (2008), which is actually a subset of the Pain Medication Questionnaire (PMQ) scale (Adams et al., 2004). The original scale was created to screen for prescription drug misuse among chronic pain patients undergoing opioid therapy, and the shortened scale was created for use among a military veteran population. Scale ranges from 1-5 with higher scores indicating a worse outcome.
Outcome measures
| Measure |
App + Treatment as Usual
n=35 Participants
The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.
As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
|
Treatment as Usual
n=39 Participants
The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
|
|---|---|---|
|
Pain Medication Questionnaire (PMQ) Shortened Scale
Baseline PMQ Mean
|
1.34 score on a scale
Standard Deviation .48
|
1.43 score on a scale
Standard Deviation .49
|
|
Pain Medication Questionnaire (PMQ) Shortened Scale
1 month PMQ Mean
|
1.37 score on a scale
Standard Deviation .43
|
1.41 score on a scale
Standard Deviation .49
|
SECONDARY outcome
Timeframe: Baseline and 1 monthA scale score for items from the 8-item Prescription Drug Attitudes Questionnaire (PDAQ; Bodenlos et al., 2014), which were adapted by the investigators for the military. The scores range from 1-5 with higher scores indicating a worse outcome.
Outcome measures
| Measure |
App + Treatment as Usual
n=33 Participants
The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.
As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
|
Treatment as Usual
n=39 Participants
The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
|
|---|---|---|
|
Prescription Drug Misuse-related Attitudes
Baseline PDAQ mean
|
1.81 score on a scale
Standard Deviation .58
|
1.82 score on a scale
Standard Deviation .75
|
|
Prescription Drug Misuse-related Attitudes
1 month PDAQ mean
|
1.84 score on a scale
Standard Deviation .62
|
1.84 score on a scale
Standard Deviation .75
|
SECONDARY outcome
Timeframe: Baseline and 1 monthMean number of correct knowledge items. Twenty-three multiple choice knowledge items assessed the participant's level of knowledge of the definition of misuse and related educational points. Possible range is 0-23 with higher scores reflecting higher knowledge levels.
Outcome measures
| Measure |
App + Treatment as Usual
n=32 Participants
The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.
As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
|
Treatment as Usual
n=39 Participants
The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
|
|---|---|---|
|
Prescription Drug Misuse-related Knowledge
Baseline knoweldge mean
|
14.09 correct items
Standard Deviation 1.84
|
13.26 correct items
Standard Deviation 2.52
|
|
Prescription Drug Misuse-related Knowledge
1 month knowledge mean
|
13.69 correct items
Standard Deviation 2.05
|
13.44 correct items
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: Baseline and 1 monthTwo investigator-developed items were used to assess the level of preparedness to talk to others (i.e., chain of command, doctor) about concerns related to one's own possible prescription drug misuse. The scale ranged from 1-5 with higher scores indicating a better outcome.
Outcome measures
| Measure |
App + Treatment as Usual
n=35 Participants
The experimental group will be provided with the prescription drug-abuse education smartphone application in addition to treatment as usual. This educational mobile phone app focuses on helping military members reduce their risk for prescription drug misuse.
As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
|
Treatment as Usual
n=39 Participants
The control group will be provided with treatment as usual, and will also receive a list of resources for help with prescription drug and other substance abuse issues.
|
|---|---|---|
|
Preparedness to Talk About Misuse
Baseline preparedness mean
|
3.24 score on a scale
Standard Deviation 1.14
|
3.41 score on a scale
Standard Deviation 1.12
|
|
Preparedness to Talk About Misuse
1 month preparedness mean
|
3.81 score on a scale
Standard Deviation .97
|
3.36 score on a scale
Standard Deviation 1.19
|
Adverse Events
App + Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
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