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| ID | Type | Description | Link |
|---|---|---|---|
| HSC-SPH-15-0632 | Other Identifier | UTHealth IRB | |
| 1R01MD010733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Case Management (UCM) | Active Comparator | Group receives standard case management at the shelter |
|
| UCM + Smartphone | Experimental | Group receives standard case management and an unlimited smartphone |
|
| Smartphone Based Case Management (SPCM) | Experimental | Group receives standard case management and an unlimited smartphone with the SPCM app |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Person Case Management at Homeless Recovery Program | Behavioral | In-Person Case Management at Homeless Recovery Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Case Management Sessions Completed | Total number of sessions completed between the randomization visit and 6-month follow-up | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Homeless Nights | 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Businelle, Ph.D. | University of Oklahoma | Principal Investigator |
| Jennifer M Reingle, Ph.D. | UTHealth School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center - OTRC | Oklahoma City | Oklahoma | 73104 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29871852 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Case Management (UCM) | Group receives standard case management at the shelter In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program |
| FG001 | UCM + Smartphone | Group receives standard case management and an unlimited smartphone 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 |
| FG002 | 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: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Case Management (UCM) | Group receives standard case management at the shelter In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program |
| BG001 | UCM + Smartphone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Case Management Sessions Completed | Total number of sessions completed between the randomization visit and 6-month follow-up | Posted | Mean | Standard Deviation | number of sessions | 6-month follow-up |
|
6 months
Definition does not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Case Management (UCM) | Group receives standard case management at the shelter In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program |
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There are no limitations or caveats to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Businelle | University of Oklahoma Health Sciences | 405-271-8001 | 50460 | michael-businelle@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2022 | Nov 13, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2022 | Nov 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D015438 | Health Behavior |
| D010349 | Patient Compliance |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Unlimited Smartphone | Behavioral | Smartphone with unlimited calls, texts, and data plan |
|
| Smartphone Based Case Management (SPCM) app | Behavioral | Smartphone Based Case Management app |
|
Total number of times each participant is booked into Dallas County Jail (using jail arrest records)
| 12 months |
| Alcohol Use | 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 | 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 |
| UTHealth School of Public Health |
| Dallas |
| Texas |
| 75390 |
| United States |
Group receives standard case management and an unlimited smartphone
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
| BG002 | 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: 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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: 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 |
|
|
| Secondary | Number of Homeless Nights | Total number of self-reported homeless nights over the 6 month study period (via Timeline Follow Back Procedures). Participants with any missing are excluded. | Posted | Mean | Standard Deviation | number of nights | 6 months |
|
|
|
| Secondary | Number of Re-arrests | Total number of times each participant is booked into Dallas County Jail (using jail arrest records) | Posted | Mean | Standard Deviation | number of arrests | 12 months |
|
|
|
| Secondary | Alcohol Use | Number of days of alcohol use (via Timeline Follow Back procedures). Any participant that missed any of the follow-ups are missing. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| Secondary | Drug Use | Number of days of drug use (via Timeline Follow Back procedures). Any participant that missed any of the 3 follow-ups are missing. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| 0 |
| 136 |
| 0 |
| 136 |
| 0 |
| 136 |
| EG001 | UCM + Smartphone | Group receives standard case management and an unlimited smartphone 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 | 0 | 134 | 0 | 134 | 0 | 134 |
| EG002 | 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: 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 | 0 | 133 | 0 | 133 | 0 | 133 |
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| D000074822 | Treatment Adherence and Compliance |
| D010549 | Personal Satisfaction |