Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Homeless Care Management App (Link2Care)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03399500
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Michael Businelle, University of Oklahoma

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).

Condition or disease Intervention/treatment Phase
Substance Use Disorders Mental Health Impairment Health Behavior Adherence, Patient Behavioral: In-Person Case Management at Homeless Recovery Program Behavioral: Unlimited Smartphone Behavioral: Smartphone Based Case Management (SPCM) app Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: m-Health to Increase Service Utilization in Recently Incarcerated Homeless Adults
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Case Management (UCM)
Group receives standard case management at the shelter
Behavioral: In-Person Case Management at Homeless Recovery Program
In-Person Case Management at Homeless Recovery Program

Experimental: UCM + Smartphone
Group receives standard case management and an unlimited smartphone
Behavioral: In-Person Case Management at Homeless Recovery Program
In-Person Case Management at Homeless Recovery Program

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

Behavioral: Unlimited Smartphone
Smartphone with unlimited calls, texts, and data plan

Behavioral: Smartphone Based Case Management (SPCM) app
Smartphone Based Case Management app




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of homeless nights [ Time Frame: 6 months ]
    Total number of self-reported homeless nights (via Timeline Follow Back Procedures)

  2. Number of arrests [ Time Frame: 12 months ]
    Total number of times each participant is booked into Dallas County Jail (using jail arrest records)

  3. Alcohol use [ Time Frame: 6 months ]
    Number of days of alcohol use (via Timeline Follow Back procedures)

  4. Drug use [ Time Frame: 6 months ]
    Number of days of drug use (via Timeline Follow Back procedures)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399500


Contacts
Layout table for location contacts
Contact: Angela M Helt, MA (405)271-8001 ext 50479 angela-helt@ouhsc.edu
Contact: Michael S Businelle, Ph.D. (405)271-8001 ext 50460 michael-businelle@ouhsc.edu

Locations
Layout table for location information
United States, Oklahoma
University of Oklahoma Health Sciences Center - OTRC Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
UTHealth School of Public Health Recruiting
Dallas, Texas, United States, 75390
Contact: Jennifer M Reingle, Ph.D.       Jennifer.Reingle@UTSouthwestern.edu   
Sponsors and Collaborators
University of Oklahoma
The University of Texas Health Science Center, Houston
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Layout table for investigator information
Principal Investigator: Michael S Businelle, Ph.D. University of Oklahoma
Principal Investigator: Jennifer M Reingle, Ph.D. UTHealth School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael Businelle, Associate Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT03399500     History of Changes
Other Study ID Numbers: 8525
HSC-SPH-15-0632 ( Other Identifier: UTHealth IRB )
1R01MD010733-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Businelle, University of Oklahoma:
Case Management
Homelessness
Smartphone
Health Related Quality of Life
Mental Health
Substance Use Disorders

Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders