Tobacco CessationNCT02510716
Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention
A study testing SGR and Support message only in people with Tobacco Cessation, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- SGR and Support message only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Sep 2016
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- criteria include non-English speaking patients
- already participating in a smoking cessation intervention study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tobacco Cessation
- Being tested
- SGR, Support message only
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGRBehavioural
Support message onlyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Scheduled Gradual Reduction (SGR) | Experimental | Four week SGR program plus support text messages. Receives: Behavioral: SGR; Behavioral: Support message only |
| Support Message Only | Active comparator | Support text messages only. Receives: Behavioral: Support message only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco cessation, defined as quit rate at 30 days, as measured by self-reported abstinence from tobacco use
Quit rate at 30 days, as measured by self-reported abstinence from tobacco use
Measured: 30-days
Secondary outcomes (2)
Feasibility, as measured by proportion of return text messages
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
Measured: 30 days
Acceptability, as measured by percentage of participants who reported that they would recommend the program to a friend
Percentage of participants who reported that they would recommend the program to a friend
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016
- Study completionSep 2016
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 Tobacco CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Alliance for Clinical Trials in Oncology, Duke Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510716
- Sponsor's protocol ID
- Pro00064813
- Status last verified
- Aug 2016
- First submitted
- 24 Jul 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Noonan D, Silva S, Njuru J, Bishop T, Fish LJ, Simmons LA, Choi SH, Pollak KI. Feasibility of a text-based smoking cessation intervention in rural older adults. Health Educ Res. 2018 Feb 1;33(1):81-88. doi: 10.1093/her/cyx080.
PubMed 29309599
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention: Testing the Feasibility of the Textto4gotobacco Intervention
- ClinicalTrials.gov ID
- NCT02510716
- Acronym / sponsor ID
- Pro00064813
- Conditions
- Tobacco Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, Alliance for Clinical Trials in Oncology, Duke Cancer Institute
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Jul 2015 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled Gradual Reduction (SGR) | Experimental | Behavioral: SGR, Behavioral: Support message onlyFour week SGR program plus support text messages. |
| Support Message Only | Active comparator | Behavioral: Support message onlySupport text messages only. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- criteria include non-English speaking patients
- already participating in a smoking cessation intervention study.
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 |
|---|---|---|
| SGR | Behavioural | Scheduled Gradual Reduction (SGR) |
| Support message only | Behavioural | Scheduled Gradual Reduction (SGR), Support Message Only |
Primary outcome
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
2 secondary outcomes
Feasibility, as measured by proportion of return text messages
Time frame: 30 days
Acceptability, as measured by percentage of participants who reported that they would recommend the program to a friend
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Derived from this study: PubMed 29309599Noonan D, Silva S, Njuru J, Bishop T, Fish LJ, Simmons LA, Choi SH, Pollak KI. Feasibility of a text-based smoking cessation intervention in rural older adults. Health Educ Res. 2018 Feb 1;33(1):81-88. doi: 10.1093/her/cyx080.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGR and Support message only in people with Tobacco Cessation, run by Duke University 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 21 Oct 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tobacco cessation, defined as quit rate at 30 days, as measured by self-reported abstinence from tobacco use (time frame: 30-days). 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 NCT02510716, 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 21 Oct 2016.