Trial Outcomes & Findings for TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification (NCT NCT02269787)
NCT ID: NCT02269787
Last Updated: 2019-05-10
Results Overview
Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
298 participants
Primary outcome timeframe
6-month follow-up
Results posted on
2019-05-10
Participant Flow
Participant milestones
| Measure |
Enhanced Telephone Monitoring
Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
|
Usual Care
Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
150
|
|
Overall Study
COMPLETED
|
126
|
140
|
|
Overall Study
NOT COMPLETED
|
22
|
10
|
Reasons for withdrawal
| Measure |
Enhanced Telephone Monitoring
Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
|
Usual Care
Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
6
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Incapacitated
|
0
|
1
|
Baseline Characteristics
TeleMonitoring to Improve Substance Use Disorder Treatment After Detoxification
Baseline characteristics by cohort
| Measure |
Enhanced Telephone Monitoring
n=148 Participants
Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
|
Usual Care
n=150 Participants
Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
48.9 years
STANDARD_DEVIATION 13.5 • n=107 Participants
|
50.1 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
112 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Married
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Years education
|
13.0 years
STANDARD_DEVIATION 1.8 • n=99 Participants
|
13.3 years
STANDARD_DEVIATION 1.9 • n=107 Participants
|
13.1 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Employed
|
46 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Homeless
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Detoxification, lifetime
|
145 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
290 Participants
n=206 Participants
|
|
Attended 12-step meeting (past 3 months)
|
81 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Number of meetings (past 3 months)
|
7.0 meetings
STANDARD_DEVIATION 14.3 • n=99 Participants
|
8.6 meetings
STANDARD_DEVIATION 15.8 • n=107 Participants
|
8.5 meetings
STANDARD_DEVIATION 22.7 • n=206 Participants
|
|
Treatment, lifetime
|
91 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
|
Treatment, 30 days
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
ASI, Alcohol severity
|
.564 units on a scale
STANDARD_DEVIATION .290 • n=99 Participants
|
.565 units on a scale
STANDARD_DEVIATION .290 • n=107 Participants
|
.565 units on a scale
STANDARD_DEVIATION .299 • n=206 Participants
|
|
ASI, Drugs severity
|
.134 units on a scale
STANDARD_DEVIATION .151 • n=99 Participants
|
.125 units on a scale
STANDARD_DEVIATION .157 • n=107 Participants
|
.130 units on a scale
STANDARD_DEVIATION .154 • n=206 Participants
|
|
ASI, Psychiatric
|
.479 units on a scale
STANDARD_DEVIATION .226 • n=99 Participants
|
.490 units on a scale
STANDARD_DEVIATION .236 • n=107 Participants
|
.485 units on a scale
STANDARD_DEVIATION .231 • n=206 Participants
|
|
Days used alcohol (past 30 days)
|
16.0 days
STANDARD_DEVIATION 10.7 • n=99 Participants
|
15.3 days
STANDARD_DEVIATION 10.8 • n=107 Participants
|
15.7 days
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Days used opioids (past 30 days)
|
5.1 days
STANDARD_DEVIATION 11.0 • n=99 Participants
|
5.6 days
STANDARD_DEVIATION 11.7 • n=107 Participants
|
5.3 days
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Serious ideas suicide (past 30 days)
|
47 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Attempted suicide (past 30 days)
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
BAM, Alcohol and drug use
|
7.2 units on a scale
STANDARD_DEVIATION 3.1 • n=99 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 2.9 • n=107 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 3.0 • n=206 Participants
|
|
BAM, Risk factors
|
15.0 units on a scale
STANDARD_DEVIATION 4.6 • n=99 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 4.3 • n=107 Participants
|
15.3 units on a scale
STANDARD_DEVIATION 4.5 • n=206 Participants
|
|
Self-efficacy, Confidence
|
62.1 units on a scale
STANDARD_DEVIATION 29.0 • n=99 Participants
|
58.4 units on a scale
STANDARD_DEVIATION 26.7 • n=107 Participants
|
60.2 units on a scale
STANDARD_DEVIATION 27.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-upPopulation: Of 298 baseline participants, 266 participated in follow-up at 6 months.
Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no.
Outcome measures
| Measure |
Enhanced Telephone Monitoring
n=126 Participants
Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
|
Usual Care
n=140 Participants
Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
|
|---|---|---|
|
Percent of Participants Who Had an Additional Inpatient Detoxification
|
33 Participants
|
47 Participants
|
Adverse Events
Enhanced Telephone Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Enhanced Telephone Monitoring
n=148 participants at risk
Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
|
Usual Care
n=150 participants at risk
Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
|
|---|---|---|
|
General disorders
Incapacitation
|
0.00%
0/148 • 6 months
|
0.67%
1/150 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christine Timko, Research Career Scientist
Department of Veterans Affairs
Phone: 6504935000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place