ClinicalTrials.gg
CompletedNCT03399500Link2CareUpdated Dec 19, 2024Results posted

Homeless Care Management App

A Phase 3 interventional study of In-Person Case Management at Homeless Recovery Program and Unlimited Smartphone in Substance Use Disorders, Mental Health Impairment and Health Behavior, sponsored by University of Oklahoma. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by University of Oklahoma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
403
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,589 studies in Substance-Related Disorders with a site in United States — 250 open to participants now, 314 under way, 4 of them phase 3. Substance-Related Disorders · United States.

Enrollment
219th of 1,447
403 · median 104
Started
2018
with 55 others
Phase 3
52 of 1,589
3 open now
Registered
903rd of 1,589
by date

Among the 1,589 studies in Substance-Related Disorders with a site in United States, this one is the 219th largest by enrollment of the 1,447 interventional ones that give a count, is one of 56 that started in 2018, is one of 52 in phase 3, and was the 903rd registered.

Substance-Related Disorders

2,241 studies on the registry are indexed under Substance-Related Disorders; 410 are open to participants now.

Browse Substance-Related Disorders studies →

Open to participants now

250 of the 1,589 studies in Substance-Related Disorders with a site in United States are open now. Recruiting first, the newest first:

245 more — sign in →

All 250 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 265 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 117 (44%) stop at 75 or younger; 55 take children under 18; 89 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,589 studies in Substance-Related Disorders with a site in United States, or all of them as a file.
02

Study 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).

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 indicating no substantial cognitive impairment.

Exclusion criteria

Exclusion Criteria

  • Cannot read English
  • Under the age of 18
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
403 participants (actual)

Study arms

  • Active comparator
    Usual Case Management (UCM)

    Group receives standard case management at the shelter

    Behavioral: 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 · Behavioral: Unlimited Smartphone

  • 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 · Behavioral: Unlimited Smartphone · Behavioral: Smartphone Based Case Management (SPCM) app

Interventions

  • BehavioralIn-Person Case Management at Homeless Recovery Program

    In-Person Case Management at Homeless Recovery Program

  • BehavioralUnlimited Smartphone

    Smartphone with unlimited calls, texts, and data plan

  • BehavioralSmartphone Based Case Management (SPCM) app

    Smartphone Based Case Management app

06

What researchers measure

Primary outcomes

  1. Number of Case Management Sessions Completed

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

    Time frame: 6-month follow-up

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. Number of Re-arrests

    Total number of times each participant is booked into Dallas County Jail (using jail arrest records)

    Time frame: 12 months

  3. Alcohol Use

    Number of days of alcohol use (via Timeline Follow Back procedures). Any participant that missed any of the follow-ups are missing.

    Time frame: 6 months

  4. 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.

    Time frame: 6 months

07

Results

Posted Dec 19, 2024
Limitations and caveats
There are no limitations or caveats to report.

Participant flow

Participant flow — Overall Study
MilestoneUsual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)
Started136134133
Completed647281
Not completed726252

Outcome measures

PrimaryNumber of Case Management Sessions Completed

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

Time frame:
6-month follow-up
Reported as:
Mean · number of sessions
Number of Case Management Sessions Completed
number of sessionsUsual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)
Number of Case Management Sessions Completed9.39 ± 11.407.69 ± 10.798.46 ± 11.17
SecondaryNumber 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.

Time frame:
6 months
Reported as:
Mean · number of nights
Number of Homeless Nights
number of nightsUsual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)
Number of Homeless Nights161.48 ± 41.64167.12 ± 31.19159.00 ± 39.09
SecondaryNumber of Re-arrests

Total number of times each participant is booked into Dallas County Jail (using jail arrest records)

Time frame:
12 months
Reported as:
Mean · number of arrests
Number of Re-arrests
number of arrestsUsual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)
Number of Re-arrests0.55 ± 0.820.64 ± 1.010.61 ± 1.06
SecondaryAlcohol Use

Number of days of alcohol use (via Timeline Follow Back procedures). Any participant that missed any of the follow-ups are missing.

Time frame:
6 months
Reported as:
Mean · days
Alcohol Use
daysUsual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)
Alcohol Use14.26 ± 31.9320.70 ± 39.0926.57 ± 41.37
SecondaryDrug Use

Number of days of drug use (via Timeline Follow Back procedures). Any participant that missed any of the 3 follow-ups are missing.

Time frame:
6 months
Reported as:
Mean · days
Drug Use
daysUsual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)
Drug Use6.33 ± 16.7522.34 ± 48.3217.61 ± 32.64

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Usual Case Management (UCM)0/136 (0%)0/136 (0%)0/136 (0%)
UCM + Smartphone0/134 (0%)0/134 (0%)0/134 (0%)
Smartphone Based Case Management (SPCM)0/133 (0%)0/133 (0%)0/133 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Usual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)Total
Mean39.68 ± 10.6340.88 ± 11.3740.46 ± 10.8440.34 ± 10.93
Sex: Female, Male
Sex: Female, Male(Participants)Usual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)Total
Female18191956
Male118115114347
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Usual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)Total
Hispanic or Latino17171751
Not Hispanic or Latino119117116352
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Usual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)Total
American Indian or Alaska Native3227
Asian1124
Native Hawaiian or Other Pacific Islander0000
Black or African American868767240
White33293294
More than one race11101940
Unknown or Not Reported251118
Region of Enrollment
Region of Enrollment(participants)Usual Case Management (UCM)UCM + SmartphoneSmartphone Based Case Management (SPCM)Total
United States136134133403
08

Study locations

2 sites
  • University of Oklahoma Health Sciences Center - OTRC
    Oklahoma City, Oklahoma 73104, United States
  • UTHealth School of Public Health
    Dallas, Texas 75390, United States
09

References and documents

Publications

  • 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. PubMed 29871852 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Nov 2023, 66 months.

Results were first posted in Dec 2024, 1 year 1 month after primary completion.

Of 13 phase 3 interventional studies under Substance-Related Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 66 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2017
First posted
Jan 16, 2018
StartActual
Apr 27, 2018
Primary completionActual
Nov 14, 2023
CompletionActual
Nov 14, 2023
Results first posted
Dec 19, 2024
Last update
Dec 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03399500
Responsible party
Sponsor
First posted
Jan 16, 2018
Start date
Apr 27, 2018
Primary completion
Nov 14, 2023
Completion
Nov 14, 2023
Results posted
Dec 19, 2024
Last update
Dec 19, 2024

Study contacts

Michael S Businelle, Ph.D.
principal investigator · University of Oklahoma
Jennifer M Reingle, Ph.D.
principal investigator · UTHealth School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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