Motivating Smokers With Mobility Impairments to Quit Smoking (ABLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The Miriam Hospital
Sponsor:
Information provided by (Responsible Party):
Belinda Borrelli, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01585610
First received: April 20, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Smoking
Behavioral: DVD Intervention
Behavioral: Standard Care Printed Materials
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Motivating Smokers With Mobility Impairments to Quit Smoking

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Smoking Status: 7-day and 30-day point prevalence [ Time Frame: 1 and 6 months Post-Intervention ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Participant Satisfaction [ Time Frame: 2, 6, 10, and 14 weeks after Baseline ] [ Designated as safety issue: No ]
    Participant satisfaction will be assessed during phone calls in the intervention period in two ways: 1) the Educational Materials Review Form Questionnaire (EMRFQ), and 2) participants' open-ended opinions about the most recent mailing (what they liked most, least, did they retain the video/print-based material, and was there anything objectionable). These will be used to evaluate DVDs and print material on: ease of use and understanding, degree of helpfulness, ability to attract attention and change behavior, and usefulness for national distribution.

  • Use of Intervention Materials [ Time Frame: 2, 6, 10, and 14 weeks after Baseline ] [ Designated as safety issue: No ]
    During follow-up phone calls in between mailings we will assess the length of time spent watching the video or reading the print materials, segments viewed or chapters read, and whether others in the household viewed the video or print-based materials. Participants will be asked simple recall questions about segments viewed or chapters read (characters, storyline, etc.) so that those who viewed the materials will be able to answer them easily.

  • Motivation to Quit [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ] [ Designated as safety issue: No ]
    We will use the Contemplation Ladder.205 Validity studies have shown associations with cognitive and behavioral indices of readiness to consider smoking cessation and with making quit attempts (e.g., intention to quit, nicotine dependence).We will also assess Stage of Change to compare its predictive and concurrent validity with this measure. We will assess motivation at baseline to assess equivalency between groups, and analyze as a covariate if necessary.

  • Self-Efficacy [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ] [ Designated as safety issue: No ]
    The Generalized Self-Efficacy Scale is a 10-item scale that assesses one's belief in the ability to respond and cope with novel or difficult situations and unexpected setbacks or obstacles. Self-efficacy to quit smoking will be assessed with a 15-item version of the Confidence Questionnaire. We will assess the mediational role of both general and specific self-efficacy in predicting outcome.

  • Depressed Mood [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ] [ Designated as safety issue: No ]
    Depressed Mood will be assessed with the 20-item Center for Epidemiologic Studies Depression Scale (CES-D210). Depressed mood is associated with difficulty quitting smoking and staying quit.Our DVD intervention will target depressed mood and assess a mediator of treatment outcome.

  • Perceived Stress [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ] [ Designated as safety issue: No ]
    The 4-item Perceived Stress Scale will be used to assess the degree to which participants perceive their environment and their experiences as stressful. The scale correlates well with scores on life-event measures, and has demonstrated good reliability. Our intervention will target stress because levels of stress can impact quitting and because a number of studies have found that persons with physical disabilities report elevated perceived stress scores. Our DVD Intervention will target stress and assess its role as a mediator of treatment outcome

  • Positive Affect [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ] [ Designated as safety issue: No ]
    We will use the Positive and Negative Affect Scale (PANAS; Watson et al 1998). The PANAS is a self-report state mood questionnaire that has a positive and negative affect subscale. Positive affect has been associated with quitting smoking and is a predictor of health and disability across many samples. Our DVD Intervention will target positive affect and we will assess the role of positive affect as a mediator of treatment outcome.

  • Behavioral Activation: Goal Setting and Achievement [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ] [ Designated as safety issue: No ]
    (Borrelli & Mermelstein). Subgoal setting will be the total number of goals set since last contact. Subgoal achievement will be the number of goals met between assessments vs the number of goals set for that time period. We will examine whether number of goals set, proportion of goals achieved, or the type of subgoal achieved (direct or indirect), have effects on follow-up smoking status. We will assess this measure as a mediator of treatment outcome.

  • Behavioral Activation: Pleasant activities [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ] [ Designated as safety issue: No ]
    The Pleasant Events Schedule measures an individual's frequency and subjective pleasure of various potentially reinforcing events and activities. Activities cover two primary areas: passive or active and social or non-social. Participants rate each item for frequency during the past month, and subjective enjoyability during that same month. We will assess this measure as a mediator of treatment outcome.


Estimated Enrollment: 560
Study Start Date: September 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DVD Program Behavioral: 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.
Other Names:
  • Behavioral Activation
  • Video
  • Home Intervention
  • People with Disabilities
  • Smoking Cessation
Active Comparator: Standard Care Printed Materials 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.
Other Names:
  • Print Materials
  • Home Intervention
  • People with Disabilities
  • Smoking Cessation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585610

Contacts
Contact: Belinda Borrelli, PhD 401-793-8040 belinda_borrelli@brown.edu
Contact: Geidy Nolasco, BS 401-793-8162 gnolasco1@lifespan.org

Locations
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Geidy Nolasco, BS    401-793-8162    gnolasco1@lifespan.org   
Contact: Shachan Cabral, BA    401-793-8168    scabral13@lifespan.org   
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Belinda Borrelli, PhD The Miriam Hospital
  More Information

Publications:
Responsible Party: Belinda Borrelli, Professor of Psychiatry and Human Behavior, Brown University School of Medicine, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01585610     History of Changes
Other Study ID Numbers: R01 CA137616-01
Study First Received: April 20, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
smoking
smoking cessation
disabled persons
behavioral research

ClinicalTrials.gov processed this record on August 19, 2014