Telehealth-Clinical Advocacy Project

NCT ID: NCT04911426

Last Updated: 2025-04-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2023-07-31

Brief Summary

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The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.

Detailed Description

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Participants in a police opioid diversion program will receive information about the research opportunity; those interested will be administered informed consent and randomized to either the (1) diversion program treatment as usual condition or (2) the enhanced condition, receiving the telehealth video call intervention with motivational interviewing and substance use treatment appointment reminders during the 12-week intervention. The study design has been modified to provide the enhanced condition with coaching and the T-CAP app to all individuals consented to the study beginning January 1, 2023.

Conditions

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Substance Use

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The two-arm randomization has been discontinued with new consented participants joining the study in 2023.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment plus telehealth

Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention.

Group Type EXPERIMENTAL

Telehealth

Intervention Type BEHAVIORAL

The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.

Interventions

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Telehealth

The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Individuals interested in joining the study will be

* Enrolled in the A Way Out Opioid Diversion Program (ODP),
* At least 18 years of age,
* Able to speak and understand English,
* Have a history of opioid, alcohol, or other substance use within last 12 months,
* Be willing to provide the research team with access to treatment records,
* Have access to a phone, tablet or computer for the informed consent activity, and
* Have a mailing address to receive a study phone issued to consented participants

Exclusion Criteria

Individuals not eligible for the study are

* Not currently enrolled in the A Way Out Opioid Diversion Program on the day of consent,
* Under the age of 18 on the day of consent,
* Unable to speak and understand English,
* Have a history of past opioid, alcohol, or other substance use longer than 12 months ago with no use of opioids in the last 12 months,
* Unwilling to authorize the research team to access treatment records,
* Without access to a phone, tablet or computer to complete the informed consent activity,
* Without a mailing address
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Texas Christian University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Pankow, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Christian University

Locations

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Lake County Public Health Department

Waukegan, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R21DA048232-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R21DA048232-02

Identifier Type: NIH

Identifier Source: org_study_id

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