Trial Outcomes & Findings for LINK: Aftercare Monitoring Project (NCT NCT00265512)
NCT ID: NCT00265512
Last Updated: 2019-01-16
Results Overview
Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
667 participants
Primary outcome timeframe
Rates of substance use measured at 3 months
Results posted on
2019-01-16
Participant Flow
Participant milestones
| Measure |
Telephone Case Monitoring Aftercare
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
|
Continuing Care as Usual
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
454
|
|
Overall Study
COMPLETED
|
168
|
359
|
|
Overall Study
NOT COMPLETED
|
45
|
95
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LINK: Aftercare Monitoring Project
Baseline characteristics by cohort
| Measure |
Telephone Case Monitoring Aftercare
n=213 Participants
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
|
Continuing Care as Usual
n=454 Participants
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
|
Total
n=667 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
51.0 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
51.3 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=99 Participants
|
433 Participants
n=107 Participants
|
636 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Rates of substance use measured at 3 monthsPercentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months).
Outcome measures
| Measure |
Telephone Case Monitoring Aftercare
n=213 Participants
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
|
Continuing Care as Usual
n=454 Participants
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
|
|---|---|---|
|
Rates of Substance Use
|
91.1 percentage of days
Standard Error 1.79
|
88.0 percentage of days
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization3 month, 6 month and 12 month measures of psychiatric symptoms, as measured by the Brief Symptom Inventory (BSI). Minimum observed score was 22; maximum observed score was 110. Higher score is worse. Minimum score possible is 22. Maximum score possible is 110.
Outcome measures
| Measure |
Telephone Case Monitoring Aftercare
n=213 Participants
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
|
Continuing Care as Usual
n=454 Participants
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
|
|---|---|---|
|
Psychiatric Symptoms
3 months
|
47.22 score on a scale
Standard Error 1.41
|
50.50 score on a scale
Standard Error 1.00
|
|
Psychiatric Symptoms
6 months
|
49.76 score on a scale
Standard Error 1.42
|
51.88 score on a scale
Standard Error 1.02
|
|
Psychiatric Symptoms
12 months
|
48.79 score on a scale
Standard Error 1.47
|
51.18 score on a scale
Standard Error 1.07
|
SECONDARY outcome
Timeframe: 3 months, 6 months and 12 months after randomizationPhysical and mental health subscales from the 12-item Medical Outcomes Study Short-form Health Survey, adapted for Veterans (VR-12). Observed scores on the MCS ranged from 2.89 to 70.39. Scores on the PCS ranged from 13.26 to 70.10. Higher scores denote better health. The minimum and maximum scores possible are 0 and 100, respectively.
Outcome measures
| Measure |
Telephone Case Monitoring Aftercare
n=209 Participants
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
|
Continuing Care as Usual
n=443 Participants
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
|
|---|---|---|
|
Health Related Quality of Life
6 month MCS
|
40.81 score on a scale
Standard Error 1.02
|
39.09 score on a scale
Standard Error .66
|
|
Health Related Quality of Life
3 month PCS
|
45.64 score on a scale
Standard Error .83
|
44.92 score on a scale
Standard Error .57
|
|
Health Related Quality of Life
6 month PCS
|
44.54 score on a scale
Standard Error .96
|
43.58 score on a scale
Standard Error .66
|
|
Health Related Quality of Life
12 month PCS
|
43.37 score on a scale
Standard Error .91
|
42.72 score on a scale
Standard Error .66
|
|
Health Related Quality of Life
3 month MCS
|
36.22 score on a scale
Standard Error .81
|
35.13 score on a scale
Standard Error .57
|
|
Health Related Quality of Life
12 month MCS
|
40.72 score on a scale
Standard Error .94
|
40.12 score on a scale
Standard Error .69
|
Adverse Events
Telephone Case Monitoring Aftercare
Serious events: 60 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuing Care as Usual
Serious events: 92 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telephone Case Monitoring Aftercare
n=213 participants at risk
Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.
SAEs were tracked, but AEs were not tracked.
|
Continuing Care as Usual
n=454 participants at risk
Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.
SAEs were tracked, but AEs were not tracked.
|
|---|---|---|
|
General disorders
hosapitalizations
|
28.2%
60/213 • Number of events 102
Serious Adverse Events were tracked. There was no tracking of other adverse events.
|
20.3%
92/454 • Number of events 206
Serious Adverse Events were tracked. There was no tracking of other adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place