Family-supported Smoking Cessation for Chronically Ill Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00448344
First received: March 14, 2007
Last updated: August 27, 2014
Last verified: August 2014
Results First Received: August 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Disease
Neoplasm
Cardiovascular Disease
Pulmonary Disease, Chronic Obstructive
Diabetes Mellitus
Hypertension
Interventions: Behavioral: Family-supported
Behavioral: Standard Telephone counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Family-supported Smoking Cessation     Standard Smoking Cessation  
STARTED     235     236  
COMPLETED     205     200  
NOT COMPLETED     30     36  
Lost to Follow-up                 20                 22  
Withdrawal by Subject                 6                 8  
Death                 3                 4  
Physician Decision                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1

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

Standard smoking cessation

Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  235     236     471  
Age  
[units: years]
Mean ± Standard Deviation
  59.1  ± 8     59.2  ± 7.7     59.2  ± 7.9  
Gender  
[units: participants]
     
Female     21     19     40  
Male     214     217     431  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     4     7     11  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     92     96     188  
White     130     121     251  
More than one race     8     7     15  
Unknown or Not Reported     1     4     5  



  Outcome Measures
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1.  Primary:   The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention   [ Time Frame: 5 months ]

2.  Secondary:   The Impact of a Family-supported Intervention on Abstinence at 12-month Follow-up   [ Time Frame: 12-months follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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