Trial · NCT01737281
Proactive Outreach for Smokers in VA Mental Health
NCT01737281, Not applicable, Completed, VA Office of Research and Development; results first posted 2019-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proactive Outreach for Smokers in VA Mental Health. Trials, record NCT01737281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01737281
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proactive Outreach for Smokers in VA Mental Health
- NCT number
- NCT01737281
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,938 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Smoking
- Interventions
- Proactive outreach, Usual care
- First posted
- 2012-11-29
- Last updated
- 2019-03-26
- Results first posted
- 2019-03-14
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Cotinine-Validated Abstinence From Smoking | 12 months | The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up. |
| Secondary | Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | 12 months | At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Cotinine-Validated Abstinence From Smoking | 12 months | Cotinine samples were obtained by mail from 53/76 people reporting abstinence in the intervention arm and 44/58 people reporting abstinence in the control arm. Note that this reflects a complete case analysis, only including people for whom outcome data are available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | 12 months | We used a complete case analysis, excluding participants for whom information was not available at 12 month follow-up | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Cotinine-Validated Abstinence From Smoking | Proactive Outreach | 36 | Participants | ||
| Number of Participants With Cotinine-Validated Abstinence From Smoking | Usual Care | 30 | Participants | ||
| Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | Proactive Outreach | 119 | Participants | ||
| Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | Usual Care | 96 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Proactive Outreach | 969 | |
| Overall Study | STARTED | Usual Care | 969 | |
| Overall Study | COMPLETED | Proactive Outreach | 603 | |
| Overall Study | COMPLETED | Usual Care | 689 | |
| Overall Study | NOT COMPLETED | Proactive Outreach | 366 | |
| Overall Study | NOT COMPLETED | Usual Care | 280 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hospitalization | Surgical and medical procedures | Intervention Arm | 39 | 969 | |
| serious | Hospitalization | Surgical and medical procedures | Control Arm | 27 | 969 | |
| serious | Life-threating event | General disorders | Intervention Arm | 0 | 969 | |
| serious | Life-threating event | General disorders | Control Arm | 1 | 969 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm | 9 | 969 |
| Total, all-cause mortality | Control Arm | 12 | 969 |
| Total, other adverse events | Intervention Arm | 0 | 969 |
| Total, other adverse events | Control Arm | 0 | 969 |
| Total, serious adverse events | Intervention Arm | 39 | 969 |
| Total, serious adverse events | Control Arm | 28 | 969 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| I01HX000817 | Proactive Outreach for Smokers in VA Mental Health | SHERMAN, SCOTT E; FU, STEVEN | VA MEDICAL CENTER | Veterans Affairs | 2014 to 2015 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Proactive Outreach vs Usual Care: Number of Participants With Cotinine-Validated Abstinence From Smoking | Trial comparisons |
| Proactive Outreach vs Usual Care: Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | Trial comparisons |
| Intervention Arm vs Control Arm: deaths from any cause | Trial comparisons |
| Intervention Arm vs Control Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01737281
GET https://conductscience.org/api/trials/v1/NCT01737281/registered