Trial Outcomes & Findings for Testing an Organizational Change Model to Address Smoking in Mental Healthcare (NCT NCT02849652)
NCT ID: NCT02849652
Last Updated: 2023-02-21
Results Overview
Client-reported use of tobacco treatment for nicotine dependence measured via self-report
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
832 participants
Primary outcome timeframe
Week 36 & Week 52
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
ATTOC Clients
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
ATTOC Staff
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
Staff from community mental healthcare clinics.
|
Usual Care Clients
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
UC Staff
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
Staff from community mental healthcare clinics.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
344
|
131
|
266
|
91
|
|
Overall Study
Week 12
|
294
|
120
|
222
|
78
|
|
Overall Study
Week 24
|
279
|
112
|
188
|
74
|
|
Overall Study
Week 36
|
250
|
104
|
166
|
66
|
|
Overall Study
Week 52
|
230
|
94
|
142
|
65
|
|
Overall Study
COMPLETED
|
230
|
94
|
142
|
65
|
|
Overall Study
NOT COMPLETED
|
114
|
37
|
124
|
26
|
Reasons for withdrawal
| Measure |
ATTOC Clients
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
ATTOC Staff
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
Staff from community mental healthcare clinics.
|
Usual Care Clients
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
UC Staff
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
Staff from community mental healthcare clinics.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
104
|
35
|
116
|
22
|
|
Overall Study
Withdrawal by Subject
|
10
|
2
|
8
|
4
|
Baseline Characteristics
Testing an Organizational Change Model to Address Smoking in Mental Healthcare
Baseline characteristics by cohort
| Measure |
Usual Care Clients
n=266 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
ATTOC Clients
n=344 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care Staff
n=91 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
ATTOC Staff
n=131 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Total
n=832 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
266 Participants
n=5 Participants
|
344 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
832 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
445 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
387 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
222 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
691 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
152 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
467 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
264 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
266 participants
n=5 Participants
|
344 participants
n=7 Participants
|
91 participants
n=5 Participants
|
131 participants
n=4 Participants
|
832 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 36 & Week 52Population: Below is it specified the number of participants were analyzed at each timepoint for this outcome.
Client-reported use of tobacco treatment for nicotine dependence measured via self-report
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
Client Reported Tobacco Medications
Week 36
|
48 Participants
|
28 Participants
|
|
Client Reported Tobacco Medications
Week 52
|
62 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: Week 36 & Week 52Population: Below is it specified the number of participants were analyzed at each timepoint for this outcome
Frequency of provision of medications for nicotine dependence measured via electronic health record (EHR) data for clients.
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
Rate of Medication to Treat Nicotine Dependence - EHR
Week 36
|
20 Participants
|
33 Participants
|
|
Rate of Medication to Treat Nicotine Dependence - EHR
Week 52
|
20 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 36 & Week 52Population: Below is it specified the number of participants were analyzed at each timepoint for this outcome
Change in proportion of smoking from baseline to follow-up time-points for clients
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
Smoking Cessation Rate
Week 36
|
11 Participants
|
4 Participants
|
|
Smoking Cessation Rate
Week 52
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 36 & Week 52Population: Below is it specified the number of participants were analyzed at each timepoint for this outcome
Mental health functioning was measured using the Revised Behavior and Symptom Identification Scale (BASIS-R), a 24-item assessment of mental health functioning that yields a total score and subscale scores for: depression, interpersonal relationships, self-harm, emotional liability, psychosis, and substance abuse. The total overall score was used. The 24 questions are scored on a 5-pointscale (from 0 to 4) with higher numbers indicating greater symptom/problem frequency or severity. The overall score can range from a 0 to a 96.
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
Mental Health Functioning
Week 36
|
27.3 Scores on a scale
Standard Deviation 21.5
|
31.8 Scores on a scale
Standard Deviation 24.4
|
|
Mental Health Functioning
Week 52
|
28.7 Scores on a scale
Standard Deviation 23.6
|
30.9 Scores on a scale
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: Week 36 & Week 52Population: Below is it specified the number of participants were analyzed at each timepoint for this outcome
The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the emotional section of questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 8-30.
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
Short-Form Health Survey Emotional
Week 36
|
18.6 Score from SF-12 (emotion questions)
Standard Deviation 3.8
|
18.5 Score from SF-12 (emotion questions)
Standard Deviation 4.3
|
|
Short-Form Health Survey Emotional
Week 52
|
17.9 Score from SF-12 (emotion questions)
Standard Deviation 4.2
|
18.8 Score from SF-12 (emotion questions)
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Week 36 and Week 52Population: Below is it specified the number of participants were analyzed at each timepoint for this outcome
The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the physical functioning section of the questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 5-15.
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
Short-Form Health Survey Physical
Week 36
|
9.5 Score from SF-12 (physical questions)
Standard Deviation 2.8
|
9.8 Score from SF-12 (physical questions)
Standard Deviation 2.9
|
|
Short-Form Health Survey Physical
Week 52
|
9.6 Score from SF-12 (physical questions)
Standard Deviation 2.7
|
10.1 Score from SF-12 (physical questions)
Standard Deviation 2.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 36 and Week 52Population: Below it is specified the number of participants that were analyzed at each timepoint for this outcome
The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26.
Outcome measures
| Measure |
ATTOC
n=104 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=66 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
S-KAP: Staff-Reported Tobacco Treatment Treatment
Week 36
|
12.3 Score from S-KAP
Standard Deviation 8.1
|
10.2 Score from S-KAP
Standard Deviation 7
|
|
S-KAP: Staff-Reported Tobacco Treatment Treatment
Week 52
|
12.8 Score from S-KAP
Standard Deviation 8.6
|
11.6 Score from S-KAP
Standard Deviation 7.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 36 and Week 52Population: Below it is specified the number of participants that were analyzed at each timepoint for this outcome
The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more barriers to tobacco treatment with the range of scores being 0-13.
Outcome measures
| Measure |
ATTOC
n=104 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=66 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
S-KAP: Staff-Reported Barriers to Treat Tobacco
Week 36
|
11.5 Score from S-KAP
Standard Deviation 4.5
|
8.1 Score from S-KAP
Standard Deviation 2.5
|
|
S-KAP: Staff-Reported Barriers to Treat Tobacco
Week 52
|
11.6 Score from S-KAP
Standard Deviation 4.6
|
7.7 Score from S-KAP
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 36 and Week 52Population: Below it is specified the number of participants that were analyzed at each timepoint for this outcome
The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items. Higher scores mean more tobacco treatment and the range of scores is 7-35.
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
S-KAS: Client Reported Tobacco Treatment Treatment From Staff
Week 36
|
16.7 Score from S-KAS
Standard Deviation 6.2
|
15.9 Score from S-KAS
Standard Deviation 5.9
|
|
S-KAS: Client Reported Tobacco Treatment Treatment From Staff
Week 52
|
16.3 Score from S-KAS
Standard Deviation 6.5
|
15.5 Score from S-KAS
Standard Deviation 6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 36 and Week 52Population: Below it is specified the number of participants that were analyzed at each timepoint for this outcome
The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective).The scores are from the summed items. Higher scores equal more skills and the range of scores is: 0-26.
Outcome measures
| Measure |
ATTOC
n=104 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=66 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
S-KAP: Staff-Reported Skills to Treat Tobacco Treat Tobacco
Week 36
|
14 Score from S-KAP
Standard Deviation 2.6
|
12.9 Score from S-KAP
Standard Deviation 3
|
|
S-KAP: Staff-Reported Skills to Treat Tobacco Treat Tobacco
Week 52
|
14 Score from S-KAP
Standard Deviation 2.7
|
13.5 Score from S-KAP
Standard Deviation 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 36 and Week 52Population: Below it is specified the number of participants that were analyzed at each timepoint for this outcome
The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items Higher scores equal more tobacco services. The range of scores is: 1-14.
Outcome measures
| Measure |
ATTOC
n=250 Participants
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care
n=166 Participants
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|---|---|---|
|
S-KAS: Client Reported Tobacco Services and Policies Services and Policies
Week 36
|
6.8 Score from S-KAS
Standard Deviation 3.6
|
5.5 Score from S-KAS
Standard Deviation 3.2
|
|
S-KAS: Client Reported Tobacco Services and Policies Services and Policies
Week 52
|
6.5 Score from S-KAS
Standard Deviation 3.5
|
5.6 Score from S-KAS
Standard Deviation 3.6
|
Adverse Events
ATTOC Clients
Serious events: 34 serious events
Other events: 0 other events
Deaths: 8 deaths
Usual Care Clients
Serious events: 15 serious events
Other events: 0 other events
Deaths: 6 deaths
ATTOC Personnel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care Personnel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATTOC Clients
n=344 participants at risk
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
|
Usual Care Clients
n=266 participants at risk
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
ATTOC Personnel
n=131 participants at risk
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
Staff from community mental healthcare clinics.
|
Usual Care Personnel
n=91 participants at risk
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
Staff from community mental healthcare clinics.
|
|---|---|---|---|---|
|
Psychiatric disorders
ORG0010
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0008
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0029
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0079
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0098
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 3 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0084
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0093
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 2 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0087
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG101
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0012
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0019
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0022
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0013
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0246
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0327
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0346
|
0.29%
1/344 • Number of events 3 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0198
|
0.29%
1/344 • Number of events 2 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0299
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0162
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0203
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0305
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0415
|
0.29%
1/344 • Number of events 2 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0374
|
0.29%
1/344 • Number of events 4 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0348
|
0.29%
1/344 • Number of events 2 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0390
|
0.29%
1/344 • Number of events 3 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0426
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0362
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0367
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0380
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0487
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0364
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0372
|
0.29%
1/344 • Number of events 2 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0421
|
0.29%
1/344 • Number of events 3 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0389
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0425
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0475
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0479
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0620
|
0.29%
1/344 • Number of events 3 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0705
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0759
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0619
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0740
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0727
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0772
|
0.29%
1/344 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/266 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Gastrointestinal disorders
ORG0922
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
General disorders
ORG0881
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Social circumstances
ORG0920
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Renal and urinary disorders
ORG0880
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
|
Psychiatric disorders
ORG0101
|
0.00%
0/344 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.38%
1/266 • Number of events 1 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/131 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
0.00%
0/91 • Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place