SmokingPhase 3ABLENCT01585610
Motivating Smokers With Mobility Impairments to Quit Smoking
A Phase 3 study testing DVD Intervention in people with Smoking, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- DVD Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking
- Being tested
- DVD Intervention, Standard Care Printed Materials
- Keywords
- smoking, smoking cessation, disabled persons, behavioral research
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVD InterventionBehavioural
Also called Behavioral Activation, Video, Home Intervention, People with Disabilities
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 MaterialsBehavioural
Also called Print Materials, Home Intervention, People with Disabilities, Smoking Cessation
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.
| Study group | Role | What they receive |
|---|---|---|
| DVD Program | Experimental | Not described Receives: Behavioral: DVD Intervention |
| Standard Care Printed Materials | Active comparator | Not described Receives: Behavioral: Standard Care Printed Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 and 6 months Post-Intervention
Secondary outcomes (9)
Participant Satisfaction
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.
Measured: 2, 6, 10, and 14 weeks after Baseline
Use of Intervention Materials
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.
Measured: 2, 6, 10, and 14 weeks after Baseline
Motivation to Quit
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.
Measured: Baseline & 1 and 6 mos Post-Intervention
Self-Efficacy
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.
Measured: Baseline & 1 and 6 mos Post-Intervention
Depressed Mood
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.
Measured: Baseline & 1 and 6 mos Post-Intervention
Perceived Stress
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
Measured: Baseline & 1 and 6 mos Post-Intervention
Positive Affect
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.
Measured: Baseline & 1 and 6 mos Post-Intervention
Behavioral Activation: Goal Setting and Achievement
(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.
Measured: Baseline & 1 and 6 mos Post-Intervention
Behavioral Activation: Pleasant activities
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.
Measured: Baseline & 1 and 6 mos Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belinda Borrelli, The Miriam Hospital
- Investigators
- Belinda Borrelli, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585610
- Sponsor's protocol ID
- R01CA137616-01
- Acronym
- ABLE
- Status last verified
- May 2015
- First submitted
- 20 Apr 2012
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21875204
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Smokers With Mobility Impairments to Quit Smoking
- ClinicalTrials.gov ID
- NCT01585610
- Acronym / sponsor ID
- ABLE / R01CA137616-01
- Conditions
- Smoking
- Keywords
- smoking, smoking cessation, disabled persons, behavioral research
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DVD Program | Experimental | Behavioral: DVD Intervention |
| Standard Care Printed Materials | Active comparator | Behavioral: Standard Care Printed Materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- chronic use of some type of assistance to walk (e.g., walker, cane, wheelchair, braces)
- ability to speak and understand English
- smoke > 3 cigarettes per day and > 100 cigarettes in their lifetime
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVD InterventionAlso: Behavioral Activation, Video, Home Intervention, People with DisabilitiesFour 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. | Behavioural | DVD Program |
| Standard Care Printed MaterialsAlso: Print Materials, Home Intervention, People with Disabilities, Smoking CessationFour 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. | Behavioural | Standard Care Printed Materials |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Background: PubMed 21875204Busch 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.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belinda Borrelli, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DVD Intervention in people with Smoking, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Status: 7-day and 30-day point prevalence (time frame: 1 and 6 months Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2015.