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| ID | Type | Description | Link |
|---|---|---|---|
| COMIRB 08-0556 | Other Identifier | University of Colorado |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced PTSD Health Buddy and Motivational Interviewing | Experimental | Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care |
|
| Usual PTSD Health Buddy Care | No Intervention | Veteran with PTSD who smoke randomly assigned to this arm received standard of care for smoking cessation and used the standard PTSD Health Buddy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivation Interviewing Counseling | Behavioral | Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During 90-session intervention 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. | Transtheoretical Model of Change questionnaire: Are you currently a smoker?
(For smokers only) Are you seriously thinking of quitting smoking?
| During 90-session intervention period |
| Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | During 90-session intervention period | |
| 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). | During the 6-month follow-up period | |
| Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Traumatic Stress Disorder Checklist | range 17-85; >50 indicates PTSD diagnosis | At end of 90-session intervention period |
| Post Traumatic Stress Disorder Checklist | range 17-85; >50 indicates PTSD diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Battaglia, PhD MS BS | Denver VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Eastern Colorado Health Care System, Denver | Denver | Colorado | 80220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23644676 | Result | Battaglia C, Stein KF. A clinical translation of the research article titled "Building a tobacco cessation telehealth care management program for veterans with posttraumatic stress disorder". J Am Psychiatr Nurses Assoc. 2013 Mar-Apr;19(2):92-7. doi: 10.1177/1078390313485907. No abstract available. | |
| 23644675 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced PTSD Health Buddy and Motivational Interviewing | Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions |
| FG001 | Usual PTSD Health Buddy Care | Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Arm 2 - 3 participants were found to be ineligible after signing consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced PTSD Health Buddy and Motivational Interviewing | Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | During 90-session intervention period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced PTSD Health Buddy and Motivational Interviewing | Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Battaglia PhD RN | Eastern Colorado Health Care System | 720-857-5099 | catherine.battaglia@va.gov |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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Are you currently a smoker?
(For smokers only) Are you seriously thinking of quitting smoking?
|
| During the 6-month follow-up period |
| At the end of the 6-month follow-up period |
| Geriatric Depression Scale | range 1-15; >6 indicates depression | At the end of the 90-session intervention period |
| Geriatric Depression Scale | range 1-15; >6 indicates depression | At the end of the 6-month follow-up period |
| Battaglia C, Benson SL, Cook PF, Prochazka A. Building a tobacco cessation telehealth care management program for veterans with posttraumatic stress disorder. J Am Psychiatr Nurses Assoc. 2013 Mar-Apr;19(2):78-91. doi: 10.1177/1078390313483314. |
| 25638351 | Derived | Peterson J, Prochazka AV, Battaglia C. Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial. BMC Health Serv Res. 2015 Feb 1;15:46. doi: 10.1186/s12913-015-0706-6. |
| BG001 | Usual PTSD Health Buddy Care | Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Post Traumatic Stress Disorder Checklist | Range 17-85; > 50 indicates PTSD diagnosis | Mean | Standard Deviation | units on a scale |
|
| Geriatric Depression Scale | Range 1-15; > 6 indicates probably depression | Mean | Standard Deviation | units on a scale |
|
| Fagerstrom Test of Nicotine Dependence | 0-3 low dependence 4-6 medium dependence 7-10 high dependence | Mean | Standard Deviation | units on a scale |
|
Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
|
|
| Primary | 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. | Transtheoretical Model of Change questionnaire: Are you currently a smoker?
(For smokers only) Are you seriously thinking of quitting smoking?
| Posted | Number | participants | During 90-session intervention period |
|
|
|
| Primary | Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | Posted | Number | participants | During 90-session intervention period |
|
|
|
| Primary | 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). | Posted | Number | participants | During the 6-month follow-up period |
|
|
|
| Primary | Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. | Posted | Number | participants | During the 6-month follow-up period |
|
|
|
| Primary | 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. | Are you currently a smoker?
(For smokers only) Are you seriously thinking of quitting smoking?
| Posted | Number | participants | During the 6-month follow-up period |
|
|
|
| Secondary | Post Traumatic Stress Disorder Checklist | range 17-85; >50 indicates PTSD diagnosis | These numbers represent those that completed the survey. | Posted | Mean | Standard Deviation | units on a scale | At end of 90-session intervention period |
|
|
|
| Secondary | Post Traumatic Stress Disorder Checklist | range 17-85; >50 indicates PTSD diagnosis | These numbers represent those that completed the survey. | Posted | Mean | Standard Deviation | units on a scale | At the end of the 6-month follow-up period |
|
|
|
| Secondary | Geriatric Depression Scale | range 1-15; >6 indicates depression | These numbers represent those that completed the survey. | Posted | Mean | Standard Deviation | units on a scale | At the end of the 90-session intervention period |
|
|
|
| Secondary | Geriatric Depression Scale | range 1-15; >6 indicates depression | These numbers represent those who completed the survey. | Posted | Mean | Standard Deviation | units on a scale | At the end of the 6-month follow-up period |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | Usual PTSD Health Buddy Care | Veteran with PTSD who smoke received standard of care for smoking cessation and use the standard PTSD Health Buddy | 0 | 89 | 0 | 89 |
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| D001523 | Mental Disorders |