Clinical trial NCT01592695: Tailored Tobacco Quitline for Rural Veterans
Official title: Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Keywords: Nicotine dependence
Smoking cessation
Telehealth
Alcohol use
Depression
Body weight
Lead sponsor: Iowa City Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2012-05-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:

1. Study the feasibility of an individually-tailored telephone intervention for rural smokers.
2. Examine the impact of the intervention on tobacco use outcomes.
3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Detailed description: Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.

Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.

In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.

Eligibility criteria: Inclusion Criteria:

* Being a veteran
* 18 + years of age
* Smoke cigarettes on at least a daily basis
* Receive primary care from the Iowa City VAMC or Coralville Clinic
* Live in a non-metropolitan area (based on RUCA codes)
* Be willing to make a quit attempt in the next 30 days
* Be capable of providing informed consent
* Have access to a telephone (land line or cell phone)
* Have a stable residence

Exclusion Criteria:

* Planning to move within the next 12 months
* Presence of a terminal illness
* Pregnancy
* Unstable psychiatric disorder (e.g., acute psychosis)
* Currently pregnant
* Incarcerated
* Institutionalized

Primary outcomes:
measure: Treatment Satisfaction
timeFrame: End of treatment (seven weeks after baseline)
Secondary outcomes:
measure: Number of Participants Abstinent From Tobacco Use
timeFrame: Six-month follow-up
measure: Alcohol Use
timeFrame: Six-month follow-up
measure: Depressive Symptoms
timeFrame: Six-month follow-up
measure: Body Weight
timeFrame: Six-month follow-up
measure: Enrollment Rate
timeFrame: 6 months after study initiation
measure: Retention
timeFrame: End of treatment (seven weeks after baseline)
measure: Treatment Attendance
timeFrame: End of treatment (seven weeks after baseline)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa City VA Health Care System
state: Iowa
Study officials:
affiliation: VRHRC-CR
name: Mark VanderWeg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10.1186/s12889-016-3493-z.