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

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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

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder IV Drug Usage Overdose Drug Addiction Substance Use Disorders Other: self-administered, e-health application Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : June 21, 2018

Arm Intervention/treatment
Experimental: AWAITS
Participants who meet criteria will receive the AWAITS self-administered, e-health application intervention.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Feedback on AWAITS [ Time Frame: Day 1 ]
    To assess the acceptability of the intervention

  2. Acceptance of list of MAT providers [ Time Frame: Day 1 ]
    Assess relative interest in MAT post-AWAITS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT03402672


Locations
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United States, Ohio
University of Cincinnati Addiction Sciences Division
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Theresa Winhusen, PhD University of Cincinnati

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Responsible Party: Theresa Winhusen, PhD, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03402672     History of Changes
Other Study ID Numbers: 2017-1074-2
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Drug Overdose
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders