NCT03399500

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 27, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 19, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

5.6 years

First QC Date

December 22, 2017

Results QC Date

November 15, 2024

Last Update Submit

December 17, 2024

Conditions

Keywords

Case ManagementHomelessnessSmartphoneHealth Related Quality of LifeMental HealthSubstance Use Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of Homeless Nights

    6 months

  • Number of Re-arrests

    12 months

  • Alcohol Use

    6 months

  • Drug Use

    6 months

Study Arms (3)

Usual Case Management (UCM)

ACTIVE COMPARATOR

Group receives standard case management at the shelter

Behavioral: In-Person Case Management at Homeless Recovery Program

UCM + Smartphone

EXPERIMENTAL

Group receives standard case management and an unlimited smartphone

Behavioral: In-Person Case Management at Homeless Recovery ProgramBehavioral: Unlimited Smartphone

Smartphone Based Case Management (SPCM)

EXPERIMENTAL

Group receives standard case management and an unlimited smartphone with the SPCM app

Behavioral: In-Person Case Management at Homeless Recovery ProgramBehavioral: Unlimited SmartphoneBehavioral: Smartphone Based Case Management (SPCM) app

Interventions

In-Person Case Management at Homeless Recovery Program

Smartphone Based Case Management (SPCM)UCM + SmartphoneUsual Case Management (UCM)

Smartphone with unlimited calls, texts, and data plan

Smartphone Based Case Management (SPCM)UCM + Smartphone

Smartphone Based Case Management app

Smartphone Based Case Management (SPCM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cannot read English
  • Under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oklahoma Health Sciences Center - OTRC

Oklahoma City, Oklahoma, 73104, United States

Location

UTHealth School of Public Health

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Reingle Gonzalez JM, Businelle MS, Kendzor D, Staton M, North CS, Swartz M. Using mHealth to Increase Treatment Utilization Among Recently Incarcerated Homeless Adults (Link2Care): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Jun 5;7(6):e151. doi: 10.2196/resprot.9868.

MeSH Terms

Conditions

Substance-Related DisordersHealth BehaviorPatient CompliancePsychological Well-Being

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehaviorPatient Acceptance of Health CareTreatment Adherence and CompliancePersonal Satisfaction

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Limitations and Caveats

There are no limitations or caveats to report.

Results Point of Contact

Title
Michael Businelle
Organization
University of Oklahoma Health Sciences

Study Officials

  • Michael S Businelle, Ph.D.

    University of Oklahoma

    PRINCIPAL INVESTIGATOR
  • Jennifer M Reingle, Ph.D.

    UTHealth School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 16, 2018

Study Start

April 27, 2018

Primary Completion

November 14, 2023

Study Completion

November 14, 2023

Last Updated

December 19, 2024

Results First Posted

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations