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Homeless Care Management App (Link2Care)

Primary Purpose

Substance Use Disorders, Mental Health Impairment, Health Behavior

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
In-Person Case Management at Homeless Recovery Program
Unlimited Smartphone
Smartphone Based Case Management (SPCM) app
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Case Management, Homelessness, Smartphone, Health Related Quality of Life, Mental Health, Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oklahoma Health Sciences Center - OTRC
  • UTHealth School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual Case Management (UCM)

UCM + Smartphone

Smartphone Based Case Management (SPCM)

Arm Description

Group receives standard case management at the shelter

Group receives standard case management and an unlimited smartphone

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

Outcomes

Primary Outcome Measures

Number of case management sessions completed
Total number of sessions completed between the randomization visit and 6-month follow-up

Secondary Outcome Measures

Number of homeless nights
Total number of self-reported homeless nights (via Timeline Follow Back Procedures)
Number of arrests
Total number of times each participant is booked into Dallas County Jail (using jail arrest records)
Alcohol use
Number of days of alcohol use (via Timeline Follow Back procedures)
Drug use
Number of days of drug use (via Timeline Follow Back procedures)

Full Information

First Posted
December 22, 2017
Last Updated
June 12, 2023
Sponsor
University of Oklahoma
Collaborators
The University of Texas Health Science Center, Houston, National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03399500
Brief Title
Homeless Care Management App
Acronym
Link2Care
Official Title
m-Health to Increase Service Utilization in Recently Incarcerated Homeless Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 27, 2018 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
The University of Texas Health Science Center, Houston, National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Mental Health Impairment, Health Behavior, Adherence, Patient
Keywords
Case Management, Homelessness, Smartphone, Health Related Quality of Life, Mental Health, Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Case Management (UCM)
Arm Type
Active Comparator
Arm Description
Group receives standard case management at the shelter
Arm Title
UCM + Smartphone
Arm Type
Experimental
Arm Description
Group receives standard case management and an unlimited smartphone
Arm Title
Smartphone Based Case Management (SPCM)
Arm Type
Experimental
Arm Description
Group receives standard case management and an unlimited smartphone with the SPCM app
Intervention Type
Behavioral
Intervention Name(s)
In-Person Case Management at Homeless Recovery Program
Intervention Description
In-Person Case Management at Homeless Recovery Program
Intervention Type
Behavioral
Intervention Name(s)
Unlimited Smartphone
Intervention Description
Smartphone with unlimited calls, texts, and data plan
Intervention Type
Behavioral
Intervention Name(s)
Smartphone Based Case Management (SPCM) app
Intervention Description
Smartphone Based Case Management app
Primary Outcome Measure Information:
Title
Number of case management sessions completed
Description
Total number of sessions completed between the randomization visit and 6-month follow-up
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Number of homeless nights
Description
Total number of self-reported homeless nights (via Timeline Follow Back Procedures)
Time Frame
6 months
Title
Number of arrests
Description
Total number of times each participant is booked into Dallas County Jail (using jail arrest records)
Time Frame
12 months
Title
Alcohol use
Description
Number of days of alcohol use (via Timeline Follow Back procedures)
Time Frame
6 months
Title
Drug use
Description
Number of days of drug use (via Timeline Follow Back procedures)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Businelle, Ph.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer M Reingle, Ph.D.
Organizational Affiliation
UTHealth School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center - OTRC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
UTHealth School of Public Health
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29871852
Citation
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.
Results Reference
derived

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Homeless Care Management App

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