Last reviewed · How we verify

NCT03399500: Link2Care

Homeless Care Management App

Completed Phase 3 Results posted Last updated 19 December 2024
What this trial tests

Phase 3 trial testing In-Person Case Management at Homeless Recovery Program in Substance Use Disorders in 403 participants. Completed in 14 November 2023.

Timeline
27 April 2018
Primary endpoint
14 November 2023
14 November 2023

Quick facts

Lead sponsorUniversity of Oklahoma
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment403
Start date27 April 2018
Primary completion14 November 2023
Estimated completion14 November 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Oklahoma

Who can join

18 and older, any sex, with Substance Use Disorders or Mental Health Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Case Management Sessions Completed Primary · 6-month follow-up

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

GroupValue95% CI
Usual Case Management (UCM)9.39± 11.40
UCM + Smartphone7.69± 10.79
Smartphone Based Case Management (SPCM)8.46± 11.17
Number of Homeless Nights Secondary · 6 months

Total number of self-reported homeless nights over the 6 month study period (via Timeline Follow Back Procedures). Participants with any missing are excluded.

GroupValue95% CI
Usual Case Management (UCM)161.48± 41.64
UCM + Smartphone167.12± 31.19
Smartphone Based Case Management (SPCM)159.00± 39.09
Number of Re-arrests Secondary · 12 months

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

GroupValue95% CI
Usual Case Management (UCM)0.55± 0.82
UCM + Smartphone0.64± 1.01
Smartphone Based Case Management (SPCM)0.61± 1.06
Alcohol Use Secondary · 6 months

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

GroupValue95% CI
Usual Case Management (UCM)14.26± 31.93
UCM + Smartphone20.70± 39.09
Smartphone Based Case Management (SPCM)26.57± 41.37
Drug Use Secondary · 6 months

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

GroupValue95% CI
Usual Case Management (UCM)6.33± 16.75
UCM + Smartphone22.34± 48.32
Smartphone Based Case Management (SPCM)17.61± 32.64

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Using mHealth to Increase Treatment Utilization Among Recently Incarcerated Homeless Adults (Link2Care): Protocol for a Randomized Controlled Trial.
    Reingle Gonzalez JM, Businelle MS, Kendzor D, Staton M, et al · · 2018 · cited 14× · PMID 29871852 · DOI 10.2196/resprot.9868

Verify or expand the search:

Other recruiting trials for Substance Use Disorders

Currently open trials in the same condition.

Other University of Oklahoma trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03399500.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing