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Mobile Application for Prescription Drug-Abuse Education (MAPDE) (MAPDE)

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ClinicalTrials.gov Identifier: NCT03165175
Recruitment Status : Completed
First Posted : May 24, 2017
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Intelligent Automation, Inc.
Information provided by (Responsible Party):
Suzanne Hurtado, Naval Health Research Center

Brief Summary:
The aims of this pilot study are: (1) to assess the feasibility and acceptability of a mobile application to educate military members about the risks of prescription drug misuse; (2) to determine if there is evidence that the mobile application plus treatment as usual reduces the risk of prescription drug misuse and shows differences in related measures compared to treatment as usual among military medical clinic patients currently taking prescription medication; and (3) if evidence of reduced risk is found, to estimate effect sizes for a future effectiveness trial. The pilot study will use a randomized controlled design with two groups. The control group will be provided with treatment as usual (TAU), and the experimental group will be provided with the prescription drug-abuse educational smartphone application in addition to treatment as usual (app + TAU). Self-reported measures of risk of misuse and related attitudes and knowledge will be administered to all participants at baseline, 1 month, and 3 months. The mobile app is a brief intervention designed to help military members to assess their risk for medication misuse and provide individualized feedback on risk level with recommendations for reducing risk. The app also contains other features, including sections in which to store information on current medications and look up drug interactions and provides resources for help.

Condition or disease Intervention/treatment Phase
Prescription Drug Abuse (Not Dependent) Behavioral: prescription drug-abuse education smartphone application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mobile Application for Prescription Drug-Abuse Education (MAPDE)
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : June 11, 2018
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App + treatment as usual
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.
Behavioral: prescription drug-abuse education smartphone application
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.

No Intervention: 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.



Primary Outcome Measures :
  1. Current Opioid Misuse Measure (COMM) [ Time Frame: Baseline and 1 month ]
    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.


Secondary Outcome Measures :
  1. Pain Medication Questionnaire (PMQ) Shortened Scale [ Time Frame: Baseline and 1 month ]
    Mean 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.

  2. Prescription Drug Misuse-related Attitudes [ Time Frame: Baseline and 1 month ]
    A 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.

  3. Prescription Drug Misuse-related Knowledge [ Time Frame: Baseline and 1 month ]
    Mean 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.

  4. Preparedness to Talk About Misuse [ Time Frame: Baseline and 1 month ]
    Two 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older (up to 55 years old)
  • On active-duty status
  • In the Navy or Marine Corps
  • Currently prescribed a medication with the potential for misuse
  • Owns a smartphone

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165175


Locations
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United States, California
Naval Health Research Center
San Diego, California, United States, 92106
Sponsors and Collaborators
Naval Health Research Center
Intelligent Automation, Inc.
Investigators
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Principal Investigator: Suzanne L Hurtado, MPH Naval Health Research Center
  Study Documents (Full-Text)

Documents provided by Suzanne Hurtado, Naval Health Research Center:
Publications:
Prins A, Ouimette P, Kimerling R, Cameron RP, Hugelshofer DS, Shaw-Hegwer J, …Sheikh JI. (2003). The primary care PTSD screen (PC-PTSD): development and operating characteristics. Primary Care Psychiatry, 9(1), 9-14.
Bodenlos, J. S., Malordy, A., Noonan, M., Mayrsohn, A., & Mistler, B. (2014). Prescription Drug Attitudes Questionnaire: Development and Validation. Psychology, 5(14), 1687-1693.
O'Neill AK. Norms, Attitudes, Perceptions, and Intentions for Benzodiazepine Prescription Drug Abuse among Adolescents (2011). Master's Theses and Doctoral Dissertations. Paper 422.
Schwab K, Baker G, Ivins B, Sluss-Tiller M, Lux W, Warden D. (2006). The Brief Traumatic Brain Injury Screen (BTBIS): Investigating the validity of a self report instrument for detecting traumatic brain injury (TBI) in troops returning from deployment in Afghanistan and Iraq. Neurology, 66, A235.
Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM. (1993, October). The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. Paper presented at the annual meeting of the International Society of Traumatic Stress Studies, San Antonio, TX. Retrieved from http://www.pdhealth.mil/library/downloads/pcl_sychometrics.doc.

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Responsible Party: Suzanne Hurtado, Research Psychologist, GS-13, Naval Health Research Center
ClinicalTrials.gov Identifier: NCT03165175    
Other Study ID Numbers: HHSN271201500071C
First Posted: May 24, 2017    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suzanne Hurtado, Naval Health Research Center:
prescription drug abuse
prescription drug misuse
risk reduction
education
military
mobile application
substance misuse
substance abuse
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders