Substance Use DisordersPhase 3Link2CareNCT03399500
Homeless Care Management App
A Phase 3 study testing In-Person Case Management at Homeless Recovery Program, Unlimited Smartphone and Smartphone Based Case Management (SPCM) app in people with Substance Use Disorders and Mental Health Impairment, run by University of Oklahoma at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Mental Health Impairment, Health Behavior
- What is being tested?
- In-Person Case Management at Homeless Recovery Program, Unlimited Smartphone and Smartphone Based Case Management (SPCM) app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2018to 14 Nov 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cannot read English
- Under the age of 18
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UTHealth School of Public Health
Dallas, Texas, 75390
University of Oklahoma Health Sciences Center - OTRC
Oklahoma City, Oklahoma, 73104
About this study
Official title: m-Health to Increase Service Utilization in Recently Incarcerated Homeless Adults
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).
- Being tested
- In-Person Case Management at Homeless Recovery Program, Unlimited Smartphone, Smartphone Based Case Management (SPCM) app
- Keywords
- Case Management, Homelessness, Smartphone, Health Related Quality of Life, Mental Health, Substance Use Disorders
- Medical subject headings
- Substance-Related Disorders, Health Behavior, Patient Compliance, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Case Management at Homeless Recovery ProgramBehavioural
In-Person Case Management at Homeless Recovery Program
Unlimited SmartphoneBehavioural
Smartphone with unlimited calls, texts, and data plan
Smartphone Based Case Management (SPCM) appBehavioural
Smartphone Based Case Management app
| Study group | Role | What they receive |
|---|---|---|
| Usual Case Management (UCM) | Active comparator | Group receives standard case management at the shelter Receives: Behavioral: In-Person Case Management at Homeless Recovery Program |
| UCM + Smartphone | Experimental | Group receives standard case management and an unlimited smartphone Receives: Behavioral: In-Person Case Management at Homeless Recovery Program; Behavioral: Unlimited Smartphone |
| Smartphone Based Case Management (SPCM) | Experimental | Group receives standard case management and an unlimited smartphone with the SPCM app Receives: Behavioral: In-Person Case Management at Homeless Recovery Program; Behavioral: Unlimited Smartphone; Behavioral: Smartphone Based Case Management (SPCM) app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Case Management Sessions Completed
Total number of sessions completed between the randomization visit and 6-month follow-up
Measured: 6-month follow-up
Secondary outcomes (4)
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.
Measured: 6 months
Number of Re-arrests
Total number of times each participant is booked into Dallas County Jail (using jail arrest records)
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start27 Apr 2018
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Michael S Businelle, Ph.D., Principal investigator, University of OklahomaJennifer M Reingle, Ph.D., Principal investigator, UTHealth School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399500
- Sponsor's protocol ID
- 8525
- Other IDs
- HSC-SPH-15-0632, 1R01MD010733-01A1
- Acronym
- Link2Care
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2017
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- m-Health to Increase Service Utilization in Recently Incarcerated Homeless Adults
- ClinicalTrials.gov ID
- NCT03399500
- Acronym / sponsor ID
- Link2Care / 8525
- Keywords
- Case Management, Homelessness, Smartphone, Health Related Quality of Life, Mental Health, Substance Use Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Posted 19 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Case Management (UCM) | Active comparator | Behavioral: In-Person Case Management at Homeless Recovery ProgramGroup receives standard case management at the shelter |
| UCM + Smartphone | Experimental | Behavioral: In-Person Case Management at Homeless Recovery Program, Behavioral: Unlimited SmartphoneGroup receives standard case management and an unlimited smartphone |
| Smartphone Based Case Management (SPCM) | Experimental | Behavioral: In-Person Case Management at Homeless Recovery Program, Behavioral: Unlimited Smartphone, Behavioral: Smartphone Based Case Management (SPCM) appGroup receives standard case management and an unlimited smartphone with the SPCM app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Cannot read English
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Case Management at Homeless Recovery ProgramIn-Person Case Management at Homeless Recovery Program | Behavioural | Smartphone Based Case Management (SPCM), UCM + Smartphone, Usual Case Management (UCM) |
| Unlimited SmartphoneSmartphone with unlimited calls, texts, and data plan | Behavioural | Smartphone Based Case Management (SPCM), UCM + Smartphone |
| Smartphone Based Case Management (SPCM) appSmartphone Based Case Management app | Behavioural | Smartphone Based Case Management (SPCM) |
Primary outcome
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
4 secondary outcomes
Number of Homeless Nights
Time frame: 6 months
Number of Re-arrests
Time frame: 12 months
Alcohol Use
Time frame: 6 months
Drug Use
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29871852Reingle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Businelle, Ph.D. principal investigator
University of Oklahoma
Jennifer M Reingle, Ph.D. principal investigator
UTHealth School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing In-Person Case Management at Homeless Recovery Program, Unlimited Smartphone and Smartphone Based Case Management (SPCM) app in people with Substance Use Disorders and Mental Health Impairment, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Case Management Sessions Completed (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.