Clinical trial NCT01585610: Motivating Smokers With Mobility Impairments to Quit Smoking
Official title: Motivating Smokers With Mobility Impairments to Quit Smoking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Smoking
Keywords: smoking
smoking cessation
disabled persons
behavioral research
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a newly designed DVD program performs better than standard, printed quit-smoking materials to help smokers who have mobility limitations (e.g., use a cane, wheelchair, braces, crutches, prosthesis) to quit smoking.

Detailed description: People with physical disabilities (mobility impairments) who use assistance to ambulate have higher smoking rates (32.5%) when compared to people who have a disability and do not need assistance (23%) and when compared to people who are not disabled (19.8%; Brawarsky et al. 2002). The aims of the current study are to: 1) develop a series of theory-based Intervention DVDs focused on motivating smoking cessation among people with mobility impairments (i.e., chronically use some type of assistance to walk such as walker, cane, wheelchair, braces, etc) and 2) test the efficacy of the Intervention DVDs versus Print-Based Standard Care among 560 smokers with mobility impairments in a randomized trial. The materials in both groups will be mailed on a monthly basis for four months, and are organized in separate sections according to readiness to quit. Participants in both groups will receive a) nicotine patches at no cost if they are ready to quit and b) brief phone calls (\~5 minutes) between mailings to assess and encourage viewing the materials. We hypothesize that smokers who are randomized to receive the Intervention DVDs will be significantly more likely to achieve 7-day and 30-day point-prevalence abstinence at 1 and 6 month follow-ups vs. those who receive Print-Based Standard Care. The Intervention DVDs will be based on Behavioral Activation Theory, and address specific barriers to quitting in this population (increased stress, decreased positive affect, increased depressed mood, activity restriction, and self-efficacy). We hypothesize that the intervention will impact these mediators directly, as well as indirectly through Behavioral Activation (goal setting and pleasant activities). If effective, our DVD intervention could have a high level of public health and clinical significance, as it could be easily disseminated at low cost through national disability-related organizations, networks of independent living centers, or physician offices. It will also substantially improve the health and quality of life for people with physical disabilities.

Eligibility criteria: Inclusion Criteria:

* chronic use of some type of assistance to walk (e.g., walker, cane, wheelchair, braces)

  * at least one year duration of the physical disability
* ability to speak and understand English
* smoke \> 3 cigarettes per day and \> 100 cigarettes in their lifetime

  * 18 years of age or older
  * visual capability to the extent that they can view the video and potentially benefit from it.

Exclusion Criteria:

* current receipt of hospice care
* temporary mobility impairment
* refusal to be tape-recorded
* pregnant or lactating
* severe cognitive impairments that would significantly compromise their ability to complete questionnaires or participate in the intervention (a Telephone Interview of Cognitive Status Mini-Mental State score \< 25)
* current severe psychiatric or substance abuse problems (\> 14 alcoholic drinks per week).

Primary outcomes:
measure: Smoking Status: 7-day and 30-day point prevalence
timeFrame: 1 and 6 months Post-Intervention
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: 2, 6, 10, and 14 weeks after Baseline
measure: Use of Intervention Materials
timeFrame: 2, 6, 10, and 14 weeks after Baseline
measure: Motivation to Quit
timeFrame: Baseline & 1 and 6 mos Post-Intervention
measure: Self-Efficacy
timeFrame: Baseline & 1 and 6 mos Post-Intervention
measure: Depressed Mood
timeFrame: Baseline & 1 and 6 mos Post-Intervention
measure: Perceived Stress
timeFrame: Baseline & 1 and 6 mos Post-Intervention
measure: Positive Affect
timeFrame: Baseline & 1 and 6 mos Post-Intervention
measure: Behavioral Activation: Goal Setting and Achievement
timeFrame: Baseline & 1 and 6 mos Post-Intervention
measure: Behavioral Activation: Pleasant activities
timeFrame: Baseline & 1 and 6 mos Post-Intervention
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Belinda Borrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Busch AM, Borrelli B. Valued life activities and readiness to quit smoking among mobility-impaired smokers. Health Psychol. 2012 Jan;31(1):122-5. doi: 10.1037/a0025218. Epub 2011 Aug 29.