- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03399500
Homeless Care Management App (Link2Care)
December 17, 2024 updated by: University of Oklahoma
m-Health to Increase Service Utilization in Recently Incarcerated Homeless Adults
There is a significant revolving door of incarceration among homeless adults, a population with substantial health disparities.
Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated.
The proposed study will use mobile technology to address these barriers and fill gaps in the understanding of the causes of the revolving door of homeless incarceration.
This research represents a step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the United States.
Smart phone apps that increase the use of available healthcare services and identify predictors of key outcomes (e.g., homelessness, re-arrest, medication compliance) could be used to reach hard to reach populations with histories of significant and persistent health disparities (e.g., homeless adults).
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
403
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center - OTRC
-
-
Texas
-
Dallas, Texas, United States, 75390
- UTHealth School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- released from Dallas County Jail in the past month
- plan to reside in the Dallas area for the next year
- enrolled in The Bridge Homeless Recovery Program
- willing and able to attend the baseline visit, randomization visit, and the 1, 3, and 6-month follow-up visits
- score ≥ 4 on the REALM-SF indicating > 6th grade English literacy level
- score >24 on the Mini-Mental State Exam indicating no substantial cognitive impairment.
Exclusion Criteria
- Cannot read English
- Under the age of 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Case Management (UCM)
Group receives standard case management at the shelter
|
In-Person Case Management at Homeless Recovery Program
|
|
Experimental: UCM + Smartphone
Group receives standard case management and an unlimited smartphone
|
In-Person Case Management at Homeless Recovery Program
Smartphone with unlimited calls, texts, and data plan
|
|
Experimental: Smartphone Based Case Management (SPCM)
Group receives standard case management and an unlimited smartphone with the SPCM app
|
In-Person Case Management at Homeless Recovery Program
Smartphone with unlimited calls, texts, and data plan
Smartphone Based Case Management app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Case Management Sessions Completed
Time Frame: 6-month follow-up
|
Total number of sessions completed between the randomization visit and 6-month follow-up
|
6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Homeless Nights
Time Frame: 6 months
|
Total number of self-reported homeless nights over the 6 month study period (via Timeline Follow Back Procedures).
Participants with any missing are excluded.
|
6 months
|
|
Number of Re-arrests
Time Frame: 12 months
|
Total number of times each participant is booked into Dallas County Jail (using jail arrest records)
|
12 months
|
|
Alcohol Use
Time Frame: 6 months
|
Number of days of alcohol use (via Timeline Follow Back procedures).
Any participant that missed any of the follow-ups are missing.
|
6 months
|
|
Drug Use
Time Frame: 6 months
|
Number of days of drug use (via Timeline Follow Back procedures).
Any participant that missed any of the 3 follow-ups are missing.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael S Businelle, Ph.D., University of Oklahoma
- Principal Investigator: Jennifer M Reingle, Ph.D., UTHealth School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 27, 2018
Primary Completion (Actual)
November 14, 2023
Study Completion (Actual)
November 14, 2023
Study Registration Dates
First Submitted
December 22, 2017
First Submitted That Met QC Criteria
January 8, 2018
First Posted (Actual)
January 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 17, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8525
- HSC-SPH-15-0632 (Other Identifier: UTHealth IRB)
- 1R01MD010733-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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