Cigarette SmokingmSMARTNCT02072005
Mobile App Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
An observational study of Cigarette Smoking, run by Duke University at 1 site in United States.
Trial summary
The primary aim of this study is to conduct a 9-patient feasibility and acceptability study of mSMART (with future studies focusing on improved medication adherence). The sample will include daily smokers who are already taking a prescribed medication. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- mSMART smartphone application
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2014
- Phase
- Observational
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants will be 15 adult, nicotine dependent smokers for a target completion sample of 9. Subjects will be allowed to meet criteria for a current comorbid psychiatric disorder (e.g., Attention-Deficit/Hyperactivity Disorder [ADHD], Post-Traumatic Stress Disorder, Major Depressive Disorder), though non-psychiatric smokers will be included as well. Participants will be taking some form of prescribed psychiatric medication or nicotine replacement therapy in pill form.
Who may be able to join
- 18-50 years of age
- Male or female
- Taking a prescribed psychiatric or smoking cessation medication in pill form over the past 30 days
- Self-report smoking at least 5 cigarettes/day
- Provides an afternoon exhaled carbon monoxide reading of at least 5 ppm.
- Cognitive functioning > 80 as assessed by the Kaufmann Brief Intelligence Test, second edition (KBIT-II)
Who cannot join
- Significant and chronic medical problems
- Estimated IQ < 80 on Kaufmann Brief Intelligence Test, Second Edition
- Meets criteria for any other Axis I Disorder (determined by the Structured Diagnostic Interview for DSM; SCID) that requires intervention and might interfere with study participation
- Current non-nicotine substance abuse or dependence or history within the last 3 months
- Females who are pregnant or attempting to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Mobile Application Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
The primary aim of this study is to conduct a 9-patient feasibility and acceptability study of mSMART (with future studies focusing on improved medication adherence). The sample will include daily smokers who are already taking a prescribed medication. There will be no change in any medication regimen in this study, and the sample will include smokers either with or without a psychiatric disorder. Subjects will be asked to use a smartphone application, or "app" (i.e. mSMART) that will provide information about their medication and when to take it. Along with smart phone, the participants will be asked to utilize an electronic pillbox (i.e. GlowCap) to further assist with medication compliance.
Read the detailed description
Subjects will be 9 nicotine dependent male and female smokers who take at least one prescribed medication regularly. This sample will allow for psychiatric comorbidity, though is not required. They will be asked to carry a smartphone for 7 days and use a smartphone application, also called an "app," (i.e. mSMART) that will provide information about their medication and when to take it. Along with smart phone, the participants will be asked to utilize an electronic pillbox (i.e. GlowCap) to further assist with medication compliance. The study consists of a Screening Visit (~4½ hours), Training Visit (~1 hour), and 1 Follow-Up Session (~2 hours). Post the Training visit, subjects will then complete the week observation period. During that time, subjects will complete experimenter-prompted assessments to assess factors that may interfere with medication adherence (e.g., psychiatric symptoms, such as forgetfulness). As part of the 'app', reminders will be sent to subjects to take their medication (e.g., the reminders will be programmed to accommodate multiple times a day dosing within dosage schedule windows). Subjects will also be provided with an electronic pillbox that will dispense the subject's medication over the 7 day observation period. After the 7 day period, subjects will return the smartphone at the follow-up visit. Primary outcome variable measured will be medication adherence as an indicator of feasibility and acceptability of the mSMART app.
This study is an observational study since participants will already be taking a medication prescribed by their own physician. The sample is a non-treatment seeking sample of adult cigarette smokers. Participants will not be asked to modify their smoking behavior or medication use in any way. Participants will receive two devices (i.e., [1] the smartphone with mSMART and [2] GlowCap) over the seven day observation period of smoking behavior and medication adherence. The ultimate goal of mSMART is to assist with medication adherence and is thus an intervention, although the goal of this study is to assess how acceptable and feasible it is in a sample already adherent to their medications. We do not predict any changes in smoking behavior or medication adherence once participants are provided with mSMART or GlowCap. GlowCap is being used to allow the investigators to measure times at which the medications were taken.
- Conditions
- Cigarette Smoking
- Being tested
- mSMART smartphone application
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mSMART smartphone applicationOther
This application is an interface that provides subjects with information and questionnaires related to their medication.
| Study group | Role | What they receive |
|---|---|---|
| Regular cigarette smokers | Not described Receives: Other: mSMART smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of alarms emitted by msmart app that subjects respond to.
Measurement of app feasibility.
Measured: 7 days
Likert response score
Likert scale responses to a questionnaire completed at follow-up visit. Questionnaire asks for agreement with statements relating to acceptability of the app.
Scale:
- = not at all
- = somewhat
- = moderately
- = extremely (example question: What was your overall satisfaction with mSMART?)
Measured: After 7 day observation period.
Secondary outcomes (1)
Percentage of study participant attrition.
Used to assess acceptability of mSMART app.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Intelligent Automation, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- John T Mitchell, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072005
- Sponsor's protocol ID
- Pro00048974
- Other IDs
- HHSN271201300022C
- Acronym
- mSMART
- Status last verified
- Jul 2014
- First submitted
- 21 Feb 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application Based Personalized Solutions and Tools for Medication Adherence of Rx Pills
- ClinicalTrials.gov ID
- NCT02072005
- Acronym / sponsor ID
- mSMART / Pro00048974
- Conditions
- Cigarette Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Intelligent Automation, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Feb 2014 (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 primary aim of this study is to conduct a 9-patient feasibility and acceptability study of mSMART (with future studies focusing on improved medication adherence). The sample will include daily smokers who are already taking a prescribed medication. There will be no change in any medication regimen in this study, and the sample will include smokers either with or without a psychiatric disorder. Subjects will be asked to use a smartphone application, or "app" (i.e. mSMART) that will provide information about their medication and when to take it. Along with smart phone, the participants will be asked to utilize an electronic pillbox (i.e. GlowCap) to further assist with medication compliance.
Detailed description
Subjects will be 9 nicotine dependent male and female smokers who take at least one prescribed medication regularly. This sample will allow for psychiatric comorbidity, though is not required. They will be asked to carry a smartphone for 7 days and use a smartphone application, also called an "app," (i.e. mSMART) that will provide information about their medication and when to take it. Along with smart phone, the participants will be asked to utilize an electronic pillbox (i.e. GlowCap) to further assist with medication compliance. The study consists of a Screening Visit (~4½ hours), Training Visit (~1 hour), and 1 Follow-Up Session (~2 hours). Post the Training visit, subjects will then complete the week observation period. During that time, subjects will complete experimenter-prompted assessments to assess factors that may interfere with medication adherence (e.g., psychiatric symptoms, such as forgetfulness). As part of the 'app', reminders will be sent to subjects to take their medication (e.g., the reminders will be programmed to accommodate multiple times a day dosing within dosage schedule windows). Subjects will also be provided with an electronic pillbox that will dispense the subject's medication over the 7 day observation period. After the 7 day period, subjects will return the smartphone at the follow-up visit. Primary outcome variable measured will be medication adherence as an indicator of feasibility and acceptability of the mSMART app.
This study is an observational study since participants will already be taking a medication prescribed by their own physician. The sample is a non-treatment seeking sample of adult cigarette smokers. Participants will not be asked to modify their smoking behavior or medication use in any way. Participants will receive two devices (i.e., [1] the smartphone with mSMART and [2] GlowCap) over the seven day observation period of smoking behavior and medication adherence. The ultimate goal of mSMART is to assist with medication adherence and is thus an intervention, although the goal of this study is to assess how acceptable and feasible it is in a sample already adherent to their medications. We do not predict any changes in smoking behavior or medication adherence once participants are provided with mSMART or GlowCap. GlowCap is being used to allow the investigators to measure times at which the medications were taken.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regular cigarette smokers | – | Other: mSMART smartphone application |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be 15 adult, nicotine dependent smokers for a target completion sample of 9. Subjects will be allowed to meet criteria for a current comorbid psychiatric disorder (e.g., Attention-Deficit/Hyperactivity Disorder [ADHD], Post-Traumatic Stress Disorder, Major Depressive Disorder), though non-psychiatric smokers will be included as well. Participants will be taking some form of prescribed psychiatric medication or nicotine replacement therapy in pill form.
Key inclusion criteria (6 listed)
- 18-50 years of age
- Male or female
- Taking a prescribed psychiatric or smoking cessation medication in pill form over the past 30 days
- Self-report smoking at least 5 cigarettes/day
- Provides an afternoon exhaled carbon monoxide reading of at least 5 ppm.
Key exclusion criteria (5 listed)
- Significant and chronic medical problems
- Estimated IQ < 80 on Kaufmann Brief Intelligence Test, Second Edition
- Meets criteria for any other Axis I Disorder (determined by the Structured Diagnostic Interview for DSM; SCID) that requires intervention and might interfere with study participation
- Current non-nicotine substance abuse or dependence or history within the last 3 months
- Females who are pregnant or attempting to become pregnant
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 |
|---|---|---|
| mSMART smartphone applicationThis application is an interface that provides subjects with information and questionnaires related to their medication. | Other | Regular cigarette smokers |
Primary outcome
Percentage of alarms emitted by msmart app that subjects respond to.
Time frame: 7 days
Measurement of app feasibility.
Likert response score
Time frame: After 7 day observation period.
Likert scale responses to a questionnaire completed at follow-up visit. Questionnaire asks for agreement with statements relating to acceptability of the app. Scale: 1. = not at all 2. = somewhat 3. = moderately 4. = extremely (example question: What was your overall satisfaction with mSMART?)
1 secondary outcome
Percentage of study participant attrition.
Time frame: 7 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 31 Jul 2014.
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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.
John T Mitchell, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking, 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 6 inclusion and 5 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 31 Jul 2014. 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?
Percentage of alarms emitted by msmart app that subjects respond to. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2014.