- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02510716
Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention
October 19, 2016 updated by: Duke University
Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention: Testing the Feasibility of the Textto4gotobacco Intervention
The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via SMS (short message service) text messaging plus SMS Support Messages in decreasing smoking in an older adult rural population.
The SGR group (n=20) will receive a four-week SGR program delivered via SMS text messages plus SMS support messages.
The control group (n=20) will receive SMS support messages to aid in quitting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
-
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
56 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 60 years of age,
- Have smoked 100 cigarettes in their lifetime and currently smoke five or more cigarettes a day on average,
- Have an address in a rural census tract defined by a RUCA code of 4-10,
- Interested in participating in a cessation program,
- Own a phone that has texting ability and free texting,
- Have general knowledge of text messaging and
- Are willing to receive and respond to text messages from the study teams, throughout the duration of the study.
Exclusion Criteria:
- criteria include non-English speaking patients
- already participating in a smoking cessation intervention study.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Scheduled Gradual Reduction (SGR)
Four week SGR program plus support text messages.
|
|
|
Active Comparator: Support Message Only
Support text messages only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tobacco cessation, defined as quit rate at 30 days, as measured by self-reported abstinence from tobacco use
Time Frame: 30-days
|
Quit rate at 30 days, as measured by self-reported abstinence from tobacco use
|
30-days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility, as measured by proportion of return text messages
Time Frame: 30 days
|
Proportion of return text messages sent per participants upon receiving "alert" text messages to use tobacco in the intervention group at 30 days Proportion of SMS support messages opened and/or read per participant
|
30 days
|
|
Acceptability, as measured by percentage of participants who reported that they would recommend the program to a friend
Time Frame: 30 days
|
Percentage of participants who reported that they would recommend the program to a friend
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
July 24, 2015
First Submitted That Met QC Criteria
July 27, 2015
First Posted (Estimate)
July 29, 2015
Study Record Updates
Last Update Posted (Estimate)
October 21, 2016
Last Update Submitted That Met QC Criteria
October 19, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Pro00064813
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.
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