Motivating Smokers With Mobility Impairments to Quit Smoking

NCT01585610 | Unknown Phase 3

• 1 other identifier: R01CA137616-01
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

smoking; smoking cessation; disabled persons; behavioral research

Outcome Measures

Primary Outcomes (1)

• Smoking Status: 7-day and 30-day point prevalence

  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.

  1 and 6 months Post-Intervention

Secondary Outcomes (9)

• Participant Satisfaction

  2, 6, 10, and 14 weeks after Baseline

• Use of Intervention Materials

  2, 6, 10, and 14 weeks after Baseline

• Motivation to Quit

  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

Study Arms (2)

DVD Program

EXPERIMENTAL

Behavioral: DVD Intervention

Standard Care Printed Materials

ACTIVE COMPARATOR

Behavioral: Standard Care Printed Materials

Interventions

DVD Intervention 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.

Also known as: Behavioral Activation, Video, Home Intervention, People with Disabilities, Smoking Cessation

DVD Program

Standard Care Printed Materials 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.

Also known as: Print Materials, Home Intervention, People with Disabilities, Smoking Cessation

Standard Care Printed Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• 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.

  PMID: 21875204 BACKGROUND

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Belinda Borrelli, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Human Behavior, Brown University School of Medicine

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 26, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

US (1)