Trial Outcomes & Findings for Homeless Care Management App (NCT NCT03399500)
NCT ID: NCT03399500
Last Updated: 2024-12-19
Results Overview
Total number of sessions completed between the randomization visit and 6-month follow-up
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
403 participants
Primary outcome timeframe
6-month follow-up
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
136
|
134
|
133
|
|
Overall Study
COMPLETED
|
64
|
72
|
81
|
|
Overall Study
NOT COMPLETED
|
72
|
62
|
52
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Homeless Care Management App
Baseline characteristics by cohort
| Measure |
Usual Case Management (UCM)
n=136 Participants
Group receives standard case management at the shelter
In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program
|
UCM + Smartphone
n=134 Participants
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
|
Smartphone Based Case Management (SPCM)
n=133 Participants
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
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.68 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
40.88 years
STANDARD_DEVIATION 11.37 • n=7 Participants
|
40.46 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
40.34 years
STANDARD_DEVIATION 10.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
347 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
352 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
240 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
136 participants
n=5 Participants
|
134 participants
n=7 Participants
|
133 participants
n=5 Participants
|
403 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-upTotal number of sessions completed between the randomization visit and 6-month follow-up
Outcome measures
| Measure |
Usual Case Management (UCM)
n=136 Participants
Group receives standard case management at the shelter
In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program
|
UCM + Smartphone
n=134 Participants
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
|
Smartphone Based Case Management (SPCM)
n=133 Participants
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
|
|---|---|---|---|
|
Number of Case Management Sessions Completed
|
9.39 number of sessions
Standard Deviation 11.40
|
7.69 number of sessions
Standard Deviation 10.79
|
8.46 number of sessions
Standard Deviation 11.17
|
SECONDARY outcome
Timeframe: 6 monthsTotal number of self-reported homeless nights over the 6 month study period (via Timeline Follow Back Procedures). Participants with any missing are excluded.
Outcome measures
| Measure |
Usual Case Management (UCM)
n=46 Participants
Group receives standard case management at the shelter
In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program
|
UCM + Smartphone
n=56 Participants
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
|
Smartphone Based Case Management (SPCM)
n=61 Participants
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
|
|---|---|---|---|
|
Number of Homeless Nights
|
161.48 number of nights
Standard Deviation 41.64
|
167.12 number of nights
Standard Deviation 31.19
|
159.00 number of nights
Standard Deviation 39.09
|
SECONDARY outcome
Timeframe: 12 monthsTotal number of times each participant is booked into Dallas County Jail (using jail arrest records)
Outcome measures
| Measure |
Usual Case Management (UCM)
n=136 Participants
Group receives standard case management at the shelter
In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program
|
UCM + Smartphone
n=134 Participants
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
|
Smartphone Based Case Management (SPCM)
n=133 Participants
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
|
|---|---|---|---|
|
Number of Re-arrests
|
0.55 number of arrests
Standard Deviation 0.82
|
0.64 number of arrests
Standard Deviation 1.01
|
0.61 number of arrests
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 6 monthsNumber of days of alcohol use (via Timeline Follow Back procedures). Any participant that missed any of the follow-ups are missing.
Outcome measures
| Measure |
Usual Case Management (UCM)
n=46 Participants
Group receives standard case management at the shelter
In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program
|
UCM + Smartphone
n=56 Participants
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
|
Smartphone Based Case Management (SPCM)
n=61 Participants
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
|
|---|---|---|---|
|
Alcohol Use
|
14.26 days
Standard Deviation 31.93
|
20.70 days
Standard Deviation 39.09
|
26.57 days
Standard Deviation 41.37
|
SECONDARY outcome
Timeframe: 6 monthsNumber of days of drug use (via Timeline Follow Back procedures). Any participant that missed any of the 3 follow-ups are missing.
Outcome measures
| Measure |
Usual Case Management (UCM)
n=46 Participants
Group receives standard case management at the shelter
In-Person Case Management at Homeless Recovery Program: In-Person Case Management at Homeless Recovery Program
|
UCM + Smartphone
n=56 Participants
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
|
Smartphone Based Case Management (SPCM)
n=61 Participants
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
|
|---|---|---|---|
|
Drug Use
|
6.33 days
Standard Deviation 16.75
|
22.34 days
Standard Deviation 48.32
|
17.61 days
Standard Deviation 32.64
|
Adverse Events
Usual Case Management (UCM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UCM + Smartphone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smartphone Based Case Management (SPCM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Businelle
University of Oklahoma Health Sciences
Phone: 405-271-8001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place