Trial Outcomes & Findings for Family-supported Smoking Cessation for Chronically Ill Veterans (NCT NCT00448344)

NCT ID: NCT00448344

Last Updated: 2015-04-24

Results Overview

self-reported 7-day point prevalent abstinence

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 471 participants
• Primary outcome timeframe: 5 months
• Results posted on: 2015-04-24

Participant Flow

Participant milestones

Measure	Family-supported Smoking Cessation Family-supported smoking cessation Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking	Standard Smoking Cessation Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Overall Study STARTED	235	236
Overall Study COMPLETED	205	200
Overall Study NOT COMPLETED	30	36

Reasons for withdrawal

Measure	Family-supported Smoking Cessation Family-supported smoking cessation Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking	Standard Smoking Cessation Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Overall Study Lost to Follow-up	20	22
Overall Study Withdrawal by Subject	6	8
Overall Study Death	3	4
Overall Study Physician Decision	1	2

Baseline Characteristics

Family-supported Smoking Cessation for Chronically Ill Veterans

Baseline characteristics by cohort

Measure	Arm 1 n=235 Participants Family-supported smoking cessation Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking	Arm 2 n=236 Participants Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions	Total n=471 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 8 • n=5 Participants	59.2 years STANDARD_DEVIATION 7.7 • n=7 Participants	59.2 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	214 Participants n=5 Participants	217 Participants n=7 Participants	431 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	92 Participants n=5 Participants	96 Participants n=7 Participants	188 Participants n=5 Participants
Race (NIH/OMB) White	130 Participants n=5 Participants	121 Participants n=7 Participants	251 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months

self-reported 7-day point prevalent abstinence

Outcome measures

Measure	Arm 1 n=235 Participants Family-supported smoking cessation Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking	Arm 2 n=236 Participants Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention	19.8 percentage of participants that quit	22.0 percentage of participants that quit

SECONDARY outcome

Timeframe: 12-months follow-up

self-reported 7- day point prevalent abstinence

Outcome measures

Measure	Arm 1 n=235 Participants Family-supported smoking cessation Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking	Arm 2 n=236 Participants Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up	22.4 percentage of participants that quit	22.4 percentage of participants that quit

Adverse Events

Arm 1

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=235 participants at risk Family-supported smoking cessation Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking	Arm 2 n=236 participants at risk Standard smoking cessation Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions
Cardiac disorders deceased during study	3.0% 7/235	5.5% 13/236

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lori Bastian

VA Connecticut

Phone: 860-667-6853

Email: lori.bastian@va.gov

Results disclosure agreements

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