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Clinical Trials/NCT00908882
NCT00908882
Completed
Not Applicable

Telehealth Care Management and Tobacco Cessation for Veterans With PTSD

US Department of Veterans Affairs1 site in 1 country178 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Use Cessation
Sponsor
US Department of Veterans Affairs
Enrollment
178
Locations
1
Primary Endpoint
Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.

Detailed Description

Background: Veterans smoke at a higher rate (30%) than the U.S. adult population (21%), and veterans with PTSD have even higher rates of smoking (53-66%). Evidence has shown that any tobacco dependence treatment strategy must be integrated in the health care system because consistent and effective delivery of tobacco cessation requires coordinated interventions. Persistent tobacco users typically cycle through multiple periods of relapse and remission. Veterans with PTSD (279,256 in 2005) who are treated for smoking cessation may need more comprehensive aid to be successful. Failure to appreciate the chronic nature of tobacco dependence may impede comprehensive and consistent treatment. Care management using telehealth has been shown to improve access to care while reducing costs for veterans with chronic diseases and has the potential to coordinate smoking cessation with care for other chronic diseases. Nurses have successfully managed chronic diseases using telehealth by focusing on increasing self-management, positive behaviors and knowledge. Nurses are vital to increasing the level of support in the community through education and motivation and by responding to medical events in order to improve veterans' health. Objectives: The study is designed to determine if adding motivational counseling and care management using the PTSD Health Buddy to usual care improves smoking quit rates of veterans with PTSD. Specific Aims are to compare: 1) self-reported quit attempts, progression through the stages of change, and quit rates, 2) patient perception of care coordination, and 3) changes in PTSD symptoms in veteran smokers with PTSD who receive a nurse-driven telephonic motivational counseling intervention triggered by responses to stage-based smoking cessation questions in addition to usual care to those who receive usual care only.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnostic and Statistical Manual of Mental Disorders IV criteria (DSM-IV) for diagnosis code 309.81 PTSD
  • Willingness to participate
  • Currently smoking 1 or more cigarettes per day

Exclusion Criteria

  • Use smokeless tobacco, pipes or cigars instead of cigarettes
  • Have imminent risk of suicide or violence
  • Have severe psychiatric symptoms or psychosocial instability likely to prevent participation in protocol (provider will assess appropriateness)
  • Have clinically apparent gross cognitive impairment
  • Unable to connect Health Buddy in home

Outcomes

Primary Outcomes

Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.

Time Frame: During the 6-month follow-up period

Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.

Time Frame: During the 6-month follow-up period

Are you currently a smoker? * Yes, I currently smoke (move to For Smokers Only section) * No, I quit within the last 6 months (ACTION STAGE) * No, I quit more than 6 months ago (MAINTENANCE STAGE) * No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours? (For smokers only) Are you seriously thinking of quitting smoking? * Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE) * Yes, within the next 6 months (CONTEMPLATION STAGE) * No, not thinking of quitting (PRECONTEMPLATION STAGE)

Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).

Time Frame: During the 6-month follow-up period

Secondary Outcomes

  • Geriatric Depression Scale(At the end of the 6-month follow-up period)
  • Post Traumatic Stress Disorder Checklist(At the end of the 6-month follow-up period)

Study Sites (1)

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