Trial Outcomes & Findings for Smartphone Based Continuing Care for Alcohol (NCT NCT02681406)
NCT ID: NCT02681406
Last Updated: 2022-03-09
Results Overview
The primary outcome measure will be percent days of heavy alcohol use (i.e., \> 5 drinks/day for men, \> 4 drinks/day for women) within each follow-up period. Studies have consistently supported the reliability and validity of the TLFB with alcohol dependent individuals. Frequency of heavy alcohol use was selected because alcohol-related problems are correlated with the frequency of heavy drinking days. This outcome is also sensitive to reductions in problematic or high risk use, which are particularly important in a disease management model.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
262 participants
Primary outcome timeframe
18 month: months 13 - 18 post baseline
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
Treatment as Usual
Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
|
Telephone Monitoring and Counseling
TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.
TMC: Brief telephone monitoring and counseling
|
ACHESS
Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.
ACHESS: Smartphone based additions focused application, encouraging social support
|
TMC + ACHESS
Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.
ACHESS: Smartphone based additions focused application, encouraging social support
TMC: Brief telephone monitoring and counseling
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
59
|
68
|
70
|
|
Overall Study
COMPLETED
|
49
|
35
|
42
|
58
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
26
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smartphone Based Continuing Care for Alcohol
Baseline characteristics by cohort
| Measure |
Treatment as Usual
n=65 Participants
Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
|
Telephone Monitoring and Counseling
n=59 Participants
TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.
TMC: Brief telephone monitoring and counseling
|
ACHESS
n=68 Participants
Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.
ACHESS: Smartphone based additions focused application, encouraging social support
|
TMC + ACHESS
n=70 Participants
Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.
ACHESS: Smartphone based additions focused application, encouraging social support
TMC: Brief telephone monitoring and counseling
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.70 years
STANDARD_DEVIATION 9.93 • n=5 Participants
|
46.07 years
STANDARD_DEVIATION 10.15 • n=7 Participants
|
48.00 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
46.72 years
STANDARD_DEVIATION 11.03 • n=4 Participants
|
46.87 years
STANDARD_DEVIATION 10.08 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
59 participants
n=7 Participants
|
68 participants
n=5 Participants
|
70 participants
n=4 Participants
|
262 participants
n=21 Participants
|
|
Short Index of Problems - Revised (SIP-R
|
11.35 units on a scale
STANDARD_DEVIATION 3.88 • n=5 Participants
|
11.47 units on a scale
STANDARD_DEVIATION 3.69 • n=7 Participants
|
11.96 units on a scale
STANDARD_DEVIATION 4.00 • n=5 Participants
|
12.36 units on a scale
STANDARD_DEVIATION 3.43 • n=4 Participants
|
11.79 units on a scale
STANDARD_DEVIATION 3.75 • n=21 Participants
|
|
Timeline Follow Back
|
41.35 percent days of heavy drinking
STANDARD_DEVIATION 29.40 • n=5 Participants
|
45.34 percent days of heavy drinking
STANDARD_DEVIATION 28.52 • n=7 Participants
|
46.36 percent days of heavy drinking
STANDARD_DEVIATION 28.59 • n=5 Participants
|
46.86 percent days of heavy drinking
STANDARD_DEVIATION 30.45 • n=4 Participants
|
44.98 percent days of heavy drinking
STANDARD_DEVIATION 29.24 • n=21 Participants
|
PRIMARY outcome
Timeframe: 18 month: months 13 - 18 post baselineThe primary outcome measure will be percent days of heavy alcohol use (i.e., \> 5 drinks/day for men, \> 4 drinks/day for women) within each follow-up period. Studies have consistently supported the reliability and validity of the TLFB with alcohol dependent individuals. Frequency of heavy alcohol use was selected because alcohol-related problems are correlated with the frequency of heavy drinking days. This outcome is also sensitive to reductions in problematic or high risk use, which are particularly important in a disease management model.
Outcome measures
| Measure |
Treatment as Usual
n=49 Participants
Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
|
Telephone Monitoring and Counseling
n=35 Participants
TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.
TMC: Brief telephone monitoring and counseling
|
ACHESS
n=42 Participants
Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.
ACHESS: Smartphone based additions focused application, encouraging social support
|
TMC + ACHESS
n=51 Participants
Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.
ACHESS: Smartphone based additions focused application, encouraging social support
TMC: Brief telephone monitoring and counseling
|
|---|---|---|---|---|
|
Time Line Follow Back, Percent Heavy Alcohol Use
|
8.10 percentage of days heavy drinking
Standard Error 2.74
|
9.97 percentage of days heavy drinking
Standard Error 3.33
|
8.79 percentage of days heavy drinking
Standard Error 3.76
|
5.49 percentage of days heavy drinking
Standard Error 1.79
|
Adverse Events
Treatment as Usual
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Telephone Monitoring and Counseling
Serious events: 8 serious events
Other events: 0 other events
Deaths: 2 deaths
ACHESS
Serious events: 9 serious events
Other events: 0 other events
Deaths: 3 deaths
TMC + ACHESS
Serious events: 11 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment as Usual
n=65 participants at risk
Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
|
Telephone Monitoring and Counseling
n=59 participants at risk
TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.
TMC: Brief telephone monitoring and counseling
|
ACHESS
n=68 participants at risk
Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.
ACHESS: Smartphone based additions focused application, encouraging social support
|
TMC + ACHESS
n=70 participants at risk
Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.
ACHESS: Smartphone based additions focused application, encouraging social support
TMC: Brief telephone monitoring and counseling
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Overdose hospitalization
|
0.00%
0/65 • 1 year, 6 months
|
3.4%
2/59 • Number of events 2 • 1 year, 6 months
|
4.4%
3/68 • Number of events 3 • 1 year, 6 months
|
0.00%
0/70 • 1 year, 6 months
|
|
Nervous system disorders
seizure disorder
|
1.5%
1/65 • Number of events 1 • 1 year, 6 months
|
1.7%
1/59 • Number of events 1 • 1 year, 6 months
|
0.00%
0/68 • 1 year, 6 months
|
1.4%
1/70 • Number of events 1 • 1 year, 6 months
|
|
Cardiac disorders
Heart issues
|
3.1%
2/65 • Number of events 2 • 1 year, 6 months
|
1.7%
1/59 • Number of events 1 • 1 year, 6 months
|
0.00%
0/68 • 1 year, 6 months
|
2.9%
2/70 • Number of events 2 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
1.5%
1/65 • Number of events 1 • 1 year, 6 months
|
1.7%
1/59 • Number of events 1 • 1 year, 6 months
|
0.00%
0/68 • 1 year, 6 months
|
0.00%
0/70 • 1 year, 6 months
|
|
Endocrine disorders
diabetes
|
1.5%
1/65 • Number of events 1 • 1 year, 6 months
|
3.4%
2/59 • Number of events 2 • 1 year, 6 months
|
0.00%
0/68 • 1 year, 6 months
|
2.9%
2/70 • Number of events 2 • 1 year, 6 months
|
|
Psychiatric disorders
psychiatric problems
|
1.5%
1/65 • Number of events 1 • 1 year, 6 months
|
1.7%
1/59 • Number of events 1 • 1 year, 6 months
|
2.9%
2/68 • Number of events 2 • 1 year, 6 months
|
1.4%
1/70 • Number of events 1 • 1 year, 6 months
|
|
Gastrointestinal disorders
Intestinal upset
|
0.00%
0/65 • 1 year, 6 months
|
0.00%
0/59 • 1 year, 6 months
|
1.5%
1/68 • Number of events 1 • 1 year, 6 months
|
0.00%
0/70 • 1 year, 6 months
|
|
Hepatobiliary disorders
kidney problems
|
0.00%
0/65 • 1 year, 6 months
|
0.00%
0/59 • 1 year, 6 months
|
1.5%
1/68 • Number of events 1 • 1 year, 6 months
|
1.4%
1/70 • Number of events 1 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.00%
0/65 • 1 year, 6 months
|
0.00%
0/59 • 1 year, 6 months
|
1.5%
1/68 • Number of events 1 • 1 year, 6 months
|
1.4%
1/70 • Number of events 1 • 1 year, 6 months
|
|
Cardiac disorders
Hypertension
|
0.00%
0/65 • 1 year, 6 months
|
0.00%
0/59 • 1 year, 6 months
|
0.00%
0/68 • 1 year, 6 months
|
1.4%
1/70 • Number of events 1 • 1 year, 6 months
|
|
Reproductive system and breast disorders
hysterectomy
|
0.00%
0/65 • 1 year, 6 months
|
0.00%
0/59 • 1 year, 6 months
|
1.5%
1/68 • Number of events 1 • 1 year, 6 months
|
0.00%
0/70 • 1 year, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cyst removal
|
0.00%
0/65 • 1 year, 6 months
|
0.00%
0/59 • 1 year, 6 months
|
1.5%
1/68 • Number of events 1 • 1 year, 6 months
|
1.4%
1/70 • Number of events 1 • 1 year, 6 months
|
|
Surgical and medical procedures
hand surgery
|
0.00%
0/65 • 1 year, 6 months
|
0.00%
0/59 • 1 year, 6 months
|
0.00%
0/68 • 1 year, 6 months
|
1.4%
1/70 • Number of events 1 • 1 year, 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place