AWAITS: A Web-based E-health Application for Active Illic... | NCT03402672

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

NCT03402672

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Apr 10, 2019Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Opioid-use Disorder
IV Drug Usage
Overdose
Drug Addiction
Substance Use Disorders

Interventions

self-administered, e-health application

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2017Actual

Primary Completion Date

Jun 21, 2018Actual

Completion Date

Jun 21, 2018Actual

First Submitted Date

Jan 10, 2018

First Submission Date that Met QC Criteria

Jan 10, 2018

First Posted Date

Jan 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2019

Last Update Posted Date

Apr 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Theresa Winhusen, PhD, Principal Investigator, University of CincinnatiPrincipal Investigator

Lead Sponsor

University of CincinnatiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to:

assess how participants like the AWAITS e-health application as measured by their feedback on the intervention
test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies.
assess the proportion of participants who accept a list of local treatment providers
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AWAITS	Experimental	Participants who meet criteria will receive the AWAITS self-administered, e-health application intervention.	Other: self-administered, e-health application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
self-administered, e-health application	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT)	To test the impact of AWAITS on knowledge about opioid overdose	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Feedback on AWAITS	To assess the acceptability of the intervention	Day 1
Acceptance of list of MAT providers	Assess relative interest in MAT post-AWAITS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Theresa Winhusen, PhD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati Addiction Sciences Division		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders
D062787	Drug Overdose
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D063487	Prescription Drug Misuse

Browse Leaves

Not provided

Browse Branches

Not provided