Trial Outcomes & Findings for TeleQuit Smoking Cessation Program (NCT NCT00123682)

NCT ID: NCT00123682

Last Updated: 2015-03-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3120 participants
• Primary outcome timeframe: 6 month
• Results posted on: 2015-03-17

Participant Flow

Participant milestones

Measure	Proactive Referral and Intensive Telephone Counseling Proactive referral and intensive telephone counseling	Reactive Referral and Intensive Counseling Reactive referral and intensive counseling	Proactive Referral and Self-help Materials Proactive referral and self-help materials	Reactive Referral and Self-help Materials Reactive referral and self-help materials
Overall Study STARTED	1069	934	592	525
Overall Study COMPLETED	749	731	438	430
Overall Study NOT COMPLETED	320	203	154	95

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TeleQuit Smoking Cessation Program

Baseline characteristics by cohort

Measure	Proactive Referral and Intensive Telephone Counseling n=1069 Participants Proactive referral and intensive telephone counseling	Reactive Referral and Intensive Counseling n=934 Participants Reactive referral and intensive counseling	Proactive Referral and Self-help Materials n=592 Participants Proactive referral and self-help materials	Reactive Referral and Self-help Materials n=525 Participants Reactive referral and self-help materials	Total n=3120 Participants Total of all reporting groups
Age, Continuous	53.7 years STANDARD_DEVIATION 10.8 • n=5 Participants	54.2 years STANDARD_DEVIATION 11.1 • n=7 Participants	54.0 years STANDARD_DEVIATION 11.8 • n=5 Participants	55.1 years STANDARD_DEVIATION 11.4 • n=4 Participants	54.0 years STANDARD_DEVIATION 11.0 • n=21 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	65 Participants n=7 Participants	40 Participants n=5 Participants	25 Participants n=4 Participants	185 Participants n=21 Participants
Sex: Female, Male Male	1014 Participants n=5 Participants	869 Participants n=7 Participants	552 Participants n=5 Participants	500 Participants n=4 Participants	2935 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	13 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	26 Participants n=21 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants	16 Participants n=7 Participants	19 Participants n=5 Participants	8 Participants n=4 Participants	74 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	231 Participants n=5 Participants	200 Participants n=7 Participants	73 Participants n=5 Participants	71 Participants n=4 Participants	575 Participants n=21 Participants
Race (NIH/OMB) White	605 Participants n=5 Participants	543 Participants n=7 Participants	342 Participants n=5 Participants	289 Participants n=4 Participants	1779 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	189 Participants n=5 Participants	170 Participants n=7 Participants	155 Participants n=5 Participants	152 Participants n=4 Participants	666 Participants n=21 Participants
Cigarettes per day	17.7 cigarettes per day STANDARD_DEVIATION 9.9 • n=5 Participants	18.3 cigarettes per day STANDARD_DEVIATION 10.3 • n=7 Participants	17.6 cigarettes per day STANDARD_DEVIATION 10.2 • n=5 Participants	20.1 cigarettes per day STANDARD_DEVIATION 11.4 • n=4 Participants	18.0 cigarettes per day STANDARD_DEVIATION 10.0 • n=21 Participants

PRIMARY outcome

Timeframe: 6 month

Outcome measures

Measure	Proactive Referral and Intensive Telephone Counseling n=749 Participants	Reactive Referral and Intensive Counseling n=731 Participants	Proactive Referral and Self-help Materials n=438 Participants	Reactive Referral and Self-help Materials n=430 Participants
7-day Point Prevalence Abstinence From Smoking	21 percentage of participants	16.4 percentage of participants	16.9 percentage of participants	16.5 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Proactive Referral and Intensive Telephone Counseling n=645 Participants	Reactive Referral and Intensive Counseling n=671 Participants	Proactive Referral and Self-help Materials n=406 Participants	Reactive Referral and Self-help Materials n=397 Participants
Use of Cessation Medications	70.1 percentage of participants	57.6 percentage of participants	74.5 percentage of participants	48.2 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Proactive Referral and Intensive Telephone Counseling n=465 Participants	Reactive Referral and Intensive Counseling n=389 Participants	Proactive Referral and Self-help Materials n=274 Participants	Reactive Referral and Self-help Materials n=245 Participants
Self-reported Quit Attempt	74 percentage of participants	61.3 percentage of participants	68.5 percentage of participants	63 percentage of participants

Adverse Events

Proactive Referral and Intensive Telephone Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reactive Referral and Intensive Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Proactive Referral and Self-help Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reactive Referral and Self-help Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Scott Sherman, PI

VA New York Harbor Healthcare System

Phone: 212-686-7500

Email: scott.sherman@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place