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Trial record 25 of 686 for:    applied AND web-

AWAITS: A Web-based E-health Application for Active Illicit Opioid Users (AWAITS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402672
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Theresa Winhusen, PhD, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE January 10, 2018
First Posted Date  ICMJE January 18, 2018
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE November 8, 2017
Actual Primary Completion Date June 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2018)
3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT) [ Time Frame: Day 1 ]
To test the impact of AWAITS on knowledge about opioid overdose
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03402672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2018)
  • Feedback on AWAITS [ Time Frame: Day 1 ]
    To assess the acceptability of the intervention
  • Acceptance of list of MAT providers [ Time Frame: Day 1 ]
    Assess relative interest in MAT post-AWAITS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AWAITS: A Web-based E-health Application for Active Illicit Opioid Users
Official Title  ICMJE A Web-based E-health Application for Active Illicit Opioid Users Providing Information About Overdose and Infection Risk Factors and Encouraging HCV/HIV Testing and Medication Assisted Treatment Seeking
Brief Summary

The purpose of this research study is to:

  1. assess how participants like the AWAITS e-health application as measured by their feedback on the intervention
  2. test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies.
  3. assess the proportion of participants who accept a list of local treatment providers
  4. test the impact of AWAITS on interest in being tested for HCV/HIV.
Detailed Description

The pre-post study of AWAITS will: 1) assess the acceptability of AWAITS as measured by participant feedback about the intervention; 2) test the impact of AWAITS on knowledge about opioid overdose, as measured by the OOTAS; 3) assess the proportion of participants who accept a list of local MAT treatment providers; and 4) test the impact of AWAITS on interest in being tested for HCV/HIV.

The acceptability of AWAITS will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about overdose and MAT) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The proportion of participants accepting a list of local MAT treatment providers will be calculated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Opioid-use Disorder
  • IV Drug Usage
  • Overdose
  • Drug Addiction
  • Substance Use Disorders
Intervention  ICMJE Other: self-administered, e-health application
AWAITS is a self-administered, e-health application and includes short videos in which patients who are successfully engaged in MAT discuss what they wish they had known about MAT when they were actively using. The intervention is designed to maximize "scalability" - the administration would entail handing an electronic device (e.g., tablet, laptop, etc.) to an individual who would then self-administer the intervention.
Study Arms  ICMJE Experimental: AWAITS
Participants who meet criteria will receive the AWAITS self-administered, e-health application intervention.
Intervention: Other: self-administered, e-health application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2019)
24
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2018)
20
Actual Study Completion Date  ICMJE June 21, 2018
Actual Primary Completion Date June 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 18 years of age
  2. Not enrolled in MAT per self-report
  3. Self-reports illicit opioid use

Exclusion Criteria:

3. Does not acknowledge reviewing "Information Sheet for Research" within REDCap

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03402672
Other Study ID Numbers  ICMJE 2017-1074-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theresa Winhusen, PhD, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Theresa Winhusen, PhD University of Cincinnati
PRS Account University of Cincinnati
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP