NCT03165175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

May 19, 2017

Results QC Date

March 13, 2019

Last Update Submit

June 14, 2019

Conditions

Prescription Drug Abuse (Not Dependent)

Keywords

prescription drug abuseprescription drug misuserisk reductioneducationmilitarymobile applicationsubstance misusesubstance abuse

Outcome Measures

Primary Outcomes (1)

  • Current Opioid Misuse Measure (COMM)

    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.

    Baseline and 1 month

Secondary Outcomes (4)

  • Pain Medication Questionnaire (PMQ) Shortened Scale

    Baseline and 1 month

  • Prescription Drug Misuse-related Attitudes

    Baseline and 1 month

  • Prescription Drug Misuse-related Knowledge

    Baseline and 1 month

  • Preparedness to Talk About Misuse

    Baseline and 1 month

Study Arms (2)

App + treatment as usual

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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.

Interventions

prescription drug-abuse education smartphone applicationBEHAVIORAL

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.

App + treatment as usual

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Health Research Center

San Diego, California, 92106, United States

Location

Related Publications (9)

  • Adams LL, Gatchel RJ, Robinson RC, Polatin P, Gajraj N, Deschner M, Noe C. Development of a self-report screening instrument for assessing potential opioid medication misuse in chronic pain patients. J Pain Symptom Manage. 2004 May;27(5):440-59. doi: 10.1016/j.jpainsymman.2003.10.009.

    PMID: 15120773BACKGROUND

  • Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. doi: 10.1016/j.pain.2007.01.014. Epub 2007 May 9.

    PMID: 17493754BACKGROUND

  • Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.

    PMID: 19996233BACKGROUND

  • Morasco BJ, Dobscha SK. Prescription medication misuse and substance use disorder in VA primary care patients with chronic pain. Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):93-9. doi: 10.1016/j.genhosppsych.2007.12.004.

    PMID: 18291290BACKGROUND

  • 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.

    BACKGROUND

  • Bodenlos, J. S., Malordy, A., Noonan, M., Mayrsohn, A., & Mistler, B. (2014). Prescription Drug Attitudes Questionnaire: Development and Validation. Psychology, 5(14), 1687-1693.

    BACKGROUND

  • O'Neill AK. Norms, Attitudes, Perceptions, and Intentions for Benzodiazepine Prescription Drug Abuse among Adolescents (2011). Master's Theses and Doctoral Dissertations. Paper 422.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersPrescription Drug MisuseRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersDrug MisuseBehavior

Limitations and Caveats

While the sample size was large enough for a pilot of the efficacy of the app based upon calculations, it may have been too limited to determine if there were subgroups of the population for whom the app might have been a more effective intervention.

Results Point of Contact

Title
Suzanne Hurtado
Organization
Naval Health Research Center
suzanne.l.hurtado.civ@mail.mil
619-553-7806

Study Officials

  • Suzanne L Hurtado, MPH

    Naval Health Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychologist, GS-13

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 24, 2017

Study Start

May 22, 2017

Primary Completion

June 11, 2018

Study Completion

October 17, 2018

Last Updated

August 5, 2019

Results First Posted

August 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)