Motivating Smokers With Mobility Impairments to Quit Smoking
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- The Miriam Hospital
- Enrollment
- 560
- Locations
- 2
- Primary Endpoint
- Smoking Status: 7-day and 30-day point prevalence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Smoking Status: 7-day and 30-day point prevalence
Time Frame: 1 and 6 months Post-Intervention
Seven-day point prevalence abstinence (no smoking at all in the previous seven days) will be assessed by self-report. We will also assess 30 day point-prevalence abstinence (no smoking at all in the previous 30 days) by self-report. Participants who have switched to other forms of tobacco will be considered "smokers." Participants who self-report no smoking will be asked to provide a Carbon Monoxide (CO) breath sample. Participants who have a CO \< 10ppm will be considered abstinent.
Secondary Outcomes
- Motivation to Quit(Baseline & 1 and 6 mos Post-Intervention)
- Perceived Stress(Baseline & 1 and 6 mos Post-Intervention)
- Participant Satisfaction(2, 6, 10, and 14 weeks after Baseline)
- Use of Intervention Materials(2, 6, 10, and 14 weeks after Baseline)
- Behavioral Activation: Pleasant activities(Baseline & 1 and 6 mos Post-Intervention)
- Self-Efficacy(Baseline & 1 and 6 mos Post-Intervention)
- Depressed Mood(Baseline & 1 and 6 mos Post-Intervention)
- Positive Affect(Baseline & 1 and 6 mos Post-Intervention)
- Behavioral Activation: Goal Setting and Achievement(Baseline & 1 and 6 mos Post-Intervention)
Investigators
Belinda Borrelli
Professor of Psychiatry and Human Behavior, Brown University School of Medicine
The Miriam Hospital