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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03399500
Other study ID # 8525
Secondary ID HSC-SPH-15-06321
Status Completed
Phase Phase 3
First received
Last updated
Start date April 27, 2018
Est. completion date November 14, 2023

Study information

Verified date January 2024
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 406
Est. completion date November 14, 2023
Est. primary completion date November 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
In-Person Case Management at Homeless Recovery Program
In-Person Case Management at Homeless Recovery Program
Unlimited Smartphone
Smartphone with unlimited calls, texts, and data plan
Smartphone Based Case Management (SPCM) app
Smartphone Based Case Management app

Locations

Country Name City State
United States UTHealth School of Public Health Dallas Texas
United States University of Oklahoma Health Sciences Center - OTRC Oklahoma City Oklahoma

Sponsors (4)

Lead Sponsor Collaborator
University of Oklahoma National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of case management sessions completed Total number of sessions completed between the randomization visit and 6-month follow-up 6-month follow-up
Secondary Number of homeless nights Total number of self-reported homeless nights (via Timeline Follow Back Procedures) 6 months
Secondary Number of arrests Total number of times each participant is booked into Dallas County Jail (using jail arrest records) 12 months
Secondary Alcohol use Number of days of alcohol use (via Timeline Follow Back procedures) 6 months
Secondary Drug use Number of days of drug use (via Timeline Follow Back procedures) 6 months
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