Overview

This trial is active, not recruiting.

Condition smoking
Treatments dvd intervention, standard care printed materials
Phase phase 3
Sponsor The Miriam Hospital
Start date September 2012
End date August 2015
Trial size 560 participants
Trial identifier NCT01585610, R01 CA137616-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
dvd intervention Behavioral Activation
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.
(Active Comparator)
standard care printed materials Print 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.

Primary Outcomes

Measure
Smoking Status: 7-day and 30-day point prevalence
time frame: 1 and 6 months Post-Intervention

Secondary Outcomes

Measure
Participant Satisfaction
time frame: 2, 6, 10, and 14 weeks after Baseline
Use of Intervention Materials
time frame: 2, 6, 10, and 14 weeks after Baseline
Motivation to Quit
time frame: Baseline & 1 and 6 mos Post-Intervention
Self-Efficacy
time frame: Baseline & 1 and 6 mos Post-Intervention
Depressed Mood
time frame: Baseline & 1 and 6 mos Post-Intervention
Perceived Stress
time frame: Baseline & 1 and 6 mos Post-Intervention
Positive Affect
time frame: Baseline & 1 and 6 mos Post-Intervention
Behavioral Activation: Goal Setting and Achievement
time frame: Baseline & 1 and 6 mos Post-Intervention
Behavioral Activation: Pleasant activities
time frame: Baseline & 1 and 6 mos Post-Intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Motivating Smokers With Mobility Impairments to Quit Smoking
Principal investigator Belinda Borrelli, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by The Miriam Hospital.