Motivating Smokers With Mobility Impairments to Quit Smoking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DVD Program

Group Type EXPERIMENTAL

DVD Intervention

Intervention Type BEHAVIORAL

Four theory-based intervention DVDs will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. DVDs focus on motivating smoking cessation among people with mobility impairments using Behavioral Activation as the primary theoretical construct. Short (\< 5 min.) phone calls will also be placed to each participant in between DVD deliveries and after receipt of DVD 4.

Standard Care Printed Materials

Group Type ACTIVE_COMPARATOR

Standard Care Printed Materials

Intervention Type BEHAVIORAL

Four sets of standard smoking cessation printed materials will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. Short (\< 5 min.) phone calls will also be placed to each participant in between materials deliveries and after the 4th and final set is sent by mail.

Interventions

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DVD Intervention

Four theory-based intervention DVDs will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. DVDs focus on motivating smoking cessation among people with mobility impairments using Behavioral Activation as the primary theoretical construct. Short (\< 5 min.) phone calls will also be placed to each participant in between DVD deliveries and after receipt of DVD 4.

Intervention Type BEHAVIORAL

Standard Care Printed Materials

Four sets of standard smoking cessation printed materials will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. Short (\< 5 min.) phone calls will also be placed to each participant in between materials deliveries and after the 4th and final set is sent by mail.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral Activation Video Home Intervention People with Disabilities Smoking Cessation Print Materials Home Intervention People with Disabilities Smoking Cessation

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No