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Family-supported Smoking Cessation for Chronically Ill Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00448344
First received: March 14, 2007
Last updated: April 6, 2015
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Lori Bastian
Organization: VA Connecticut
phone: 860-667-6853
e-mail: lori.bastian@va.gov


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00448344     History of Changes
Other Study ID Numbers: IIR 05-202
Study First Received: March 14, 2007
Results First Received: August 13, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government