- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01585610
Motivating Smokers With Mobility Impairments to Quit Smoking (ABLE)
May 13, 2015 updated by: Belinda Borrelli, The Miriam Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
560
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02906
- The Miriam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DVD Program
|
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:
|
Active Comparator: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 and 6 months Post-Intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Satisfaction
Time Frame: 2, 6, 10, and 14 weeks after Baseline
|
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.
|
2, 6, 10, and 14 weeks after Baseline
|
Use of Intervention Materials
Time Frame: 2, 6, 10, and 14 weeks after Baseline
|
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.
|
2, 6, 10, and 14 weeks after Baseline
|
Motivation to Quit
Time Frame: Baseline & 1 and 6 mos Post-Intervention
|
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.
|
Baseline & 1 and 6 mos Post-Intervention
|
Self-Efficacy
Time Frame: Baseline & 1 and 6 mos Post-Intervention
|
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.
|
Baseline & 1 and 6 mos Post-Intervention
|
Depressed Mood
Time Frame: Baseline & 1 and 6 mos Post-Intervention
|
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.
|
Baseline & 1 and 6 mos Post-Intervention
|
Perceived Stress
Time Frame: Baseline & 1 and 6 mos Post-Intervention
|
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
|
Baseline & 1 and 6 mos Post-Intervention
|
Positive Affect
Time Frame: Baseline & 1 and 6 mos Post-Intervention
|
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.
|
Baseline & 1 and 6 mos Post-Intervention
|
Behavioral Activation: Goal Setting and Achievement
Time Frame: Baseline & 1 and 6 mos Post-Intervention
|
(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.
|
Baseline & 1 and 6 mos Post-Intervention
|
Behavioral Activation: Pleasant activities
Time Frame: Baseline & 1 and 6 mos Post-Intervention
|
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.
|
Baseline & 1 and 6 mos Post-Intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Belinda Borrelli, PhD, The Miriam Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Anticipated)
August 1, 2015
Study Completion (Anticipated)
May 1, 2016
Study Registration Dates
First Submitted
April 20, 2012
First Submitted That Met QC Criteria
April 25, 2012
First Posted (Estimate)
April 26, 2012
Study Record Updates
Last Update Posted (Estimate)
May 14, 2015
Last Update Submitted That Met QC Criteria
May 13, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- R01CA137616-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking
-
University of VirginiaRecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Quitting SmokingUnited States
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Columbia UniversityNational Cancer Institute (NCI)RecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking BehaviorsUnited States
-
National Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Cigarette Smoking | Tobacco, SmokingUnited States
-
Maastricht University Medical CenterThe Investigative Desk; SEO Amsterdam Economics; IVO Research InstituteEnrolling by invitationSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsNetherlands
-
Jennifer Marler, MDCompletedSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsUnited States
-
Medical University of South CarolinaRecruitingSmoking | Smoking Cessation | Tobacco Smoking | Cigarette SmokingUnited States
-
Ghana Health ServicesKwame Nkrumah University of Science and TechnologyNot yet recruitingSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking Behaviors
Clinical Trials on DVD Intervention
-
Cooper Green Mercy HospitalUniversity of Alabama at BirminghamUnknownHypertensionUnited States
-
University of DelawareNational Institute on Drug Abuse (NIDA)CompletedAcquired Immunodeficiency Syndrome | Hepatitis C | Human Immunodeficiency VirusUnited States
-
Washington University School of MedicineCompleted
-
Connecticut Children's Medical CenterCompletedChildren Who Present to the ED With Minor Febrile IllnessesUnited States
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBreast, Cervical or Colorectal Cancer Screening NeededUnited States
-
University of CincinnatiFoundation for Informed Medical Decision MakingCompletedCoronary Artery DiseaseUnited States
-
The Miriam HospitalNational Institute of Mental Health (NIMH); Brown University; University of Rochester and other collaboratorsCompletedHIV Infections | Sexually Transmitted Diseases | HIVUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center; Columbia... and other collaboratorsCompletedChildhood CancersUnited States
-
University of HawaiiQueen's Medical Center; I Ola Lahui, Inc.; Ke Ola Mamo; Queen Lili'uokalani Children... and other collaboratorsCompletedObesity | Overweight | Weight Loss | Weight Loss MaintenanceUnited States
-
The University of Hong KongThe Boys' and Girls' Clubs Association of Hong KongCompleted