SmokingEarly Phase 1NCT00435903
Pilot Study of the Feasibility of Palm Pilots in Monitoring Smoking Behavior in Individuals With Chronic Mental Illness
A Early Phase 1 study testing Palm Pilot in people with Smoking, run by North Suffolk Mental Health Association at 1 site in United States.
Trial summary
The goal of this open trial is to pilot the use of palm pilots as a tool for monitoring smoking behavior in individuals with serious mental illness. That is, the investigators aim to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring smoking behavior and for coaching participants to… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Smoking
- What is being tested?
- Palm Pilot
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Oct 2005
- Phase
- Early Phase 1
- 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
Who may be able to join
- Age between 18 and 50
- Having a DSM-IV psychiatric diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or major depression with significant functional impairment
- Smoking 10 or more cigarettes per day
- Having an expired air minimum CO of at least 10 ppm
- Normal or corrected to normal eyesight and adequate manual dexterity to operate a palm pilot (will be assessed on case by case basis with participants completing an initial screening which involves demonstrating basic ability to read the screen on the palm pilot and operate the stylus)
- Stable psychiatric symptoms
Who cannot join
- Mini Mental State exam score less than 24/30
- Currently using nicotine replacement therapy
- Diagnosis of dementia, neurodegenerative disease, substance abuse or dependence disorders (to substances other than nicotine) active within the last 3 months
- Patients who, in the investigator's opinion, pose a current homicide or suicide risk
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this open trial is to pilot the use of palm pilots as a tool for monitoring smoking behavior in individuals with serious mental illness. That is, the investigators aim to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring smoking behavior and for coaching participants to use a strategy for delaying and reducing cigarette use.
Read the detailed description
The specific aims of this project are:
- We will compare the accuracy of daily palm pilot recordings to paper and pencil measures. We hypothesize that the number of cigarettes smoked according to daily palm pilot recordings will correlate as well with salivary cotinine levels (a metabolite of nicotine) as will daily paper and pencil recordings. That is, we expect that palm recordings will be as accurate as paper and pencil recordings.
- We will compare the total number of smoked cigarettes reported by the daily ratings (paper and pencil or palm pilot) to participants' report of their weekly totals. We expect that participants will tend to underestimate the number of cigarettes smoked when asked to report weekly totals. That is, we hypothesize that participants will report smoking fewer cigarettes in their weekly total compared to their daily reports of smoking and that totals based on daily reports will correlate more strongly with cotinine levels.
- We will measure the frequency at which participants access a screen on the Palm Pilot that presents the "4 D's," which are four strategies for delaying or reducing cigarette use. Participants will be asked to access this screen when they experience an urge to smoke. We hypothesize that at least some participants will make use of this screen.
- We will assess the effect of daily monitoring on salivary cotinine levels. Smoking reduction is not a specific goal of this program. However, participants who access the 4D's coaching screen on the Palm when they have an urge may reduce their smoking. We hypothesize that reduction in cotinine levels will be correlated with greater frequency of accessing the 4 D's screen. That is, participants who access the 4D's screen most often (more than 5 times per day) are expected to show more reduction in cotinine levels compared to baseline than are participants who do not access the 4 D's screen
- We will measure participants' level of satisfaction with the Palm Pilot and the paper and pencil versions of the monitoring forms. We hypothesize that participants will report high levels of satisfaction with the Palm Pilot version, and that these will be as high as or higher than levels of satisfaction with the paper and pencil version.
- We will assess whether participants are able to complete a rating scale on the Palm Pilot. We hypothesize that participants will be able to complete this scale.
- We will assess the amount of training time required to train participants to use either the paper and pencil or Palm Pilot versions of the monitoring form.
Methods and Procedures: Ten participants will come in for four, 45-minute assessments, for a total of 3 hours, over a 3-week period. At each visit, smoking behavior will be assessed using either the palm pilot or paper and pencil recordings and carbon monoxide and salivary cotinine will be measured. Training will be provided in the use of the palms and participants will do a "trial" recording of data before their actual data are recorded. In addition, during each week in which participants use Palm Pilots, they will be asked to come into the clinic for a mid-week visit to have their Palm Pilot charged and synced with the computer. No assessments will be completed during these mid-week visits.
Subjects will serve as their own controls in the study. Participants will be asked to keep track of their smoking and to answer questions about their smoking using two formats: paper and pencil forms and forms programmed on Palm Pilots. For the Palm Pilot recordings, participants will be loaned a Palm Pilot to use to answer questions about their smoking whenever they smoke. Palm recordings and paper and pencil recordings will be compared to salivary cotinine and carbon monoxide levels. To control for the effects of one data collection strategy being used before the other, subjects will be randomized to do either paper and pencil recordings or palm recordings first. We will also teach clients a basic behavioral strategy ("the four D's") for cutting down on the amount of cigarettes smoked. The four D's stand for 1) deep breathing, 2) drink fluids, 3) delay, and 4) do something else. The paper and Palm Pilot versions of the questionnaires will include a reminder about the four D's to encourage participants to cut down on the amount of cigarettes smoked per day. In addition, participants will be asked to fill out the Hughes-Hatsukami Scale, which is a measure of nicotine withdrawal symptoms.
In summary, all participants will take part in the following:
- Assessment 1: Baseline assessment (week 0) will include self report of cigarettes smoked in the past week, a measure of salivary cotinine level, and expired air carbon monoxide level. The four D's strategy for cutting down number of cigarettes smoked will be introduced.
- For Week 1, subjects will be asked to keep daily paper-and-pencil records of their smoking behavior for the week following baseline. Subjects will be asked to report on number of cigarettes smoked, time of day smoked, how they felt when they smoked, and the degree to which they craved the cigarette. They will also be asked to indicate whether or not they tried any of the four D's strategies to avoid or delay smoking. Additionally, they will fill out the Hughes-Hatsukami Scale once per day.
- Assessment 2: Subjects will then return for assessment at the end of the week of paper and pencil recordings. Salivary cotinine and carbon monoxide levels will be measured at this time. Additionally, subjects will fill out a satisfaction questionnaire regarding their satisfaction with the paper-and-pencil method of monitoring their smoking.
- Subjects will be trained to record their smoking behavior using a Palm Pilot version of the recording form. Subjects will be loaned a Palm Pilot that will be programmed to present a computerized version of the smoking behavior monitor form that was used to make paper and pencil recordings. Subjects will be asked to hit a button on the Palm Pilot whenever they have an urge to smoke, and to complete the recordings on the Palm Pilot in the same manner as they did with paper-and-pencil recordings. However, Palm Pilots will be set to beep 1x per day (participant's stated wake-up time) to prompt participants to make a summary recording of number of cigarettes per day and to complete the Hughes-Hatsukami Scale. Additionally, the morning questionnaire will include a reminder screen that encourages participants to make the recordings and to practice the four D's. Subjects will practice using the Palm Pilot over Week 2.
- Mid-week visit 1: Participants will return to the clinic during the middle of the week to charge and hot-sync (synchronize with the computer) their Palm Pilot. No assessments will occur during this visit.
- Assessment 3: Subjects will return after a week of practice. Salivary cotinine and carbon monoxide levels will be measured, as well as smoking withdrawal symptoms.
- Subjects will then be asked to record their smoking on the palm pilots for another week (Week 3).
- Mid-week visit 2: Participants will return to the clinic during the middle of the week to charge and hot-sync (synchronize with the computer) their Palm Pilot. No assessments will occur during this visit.
- Assessment 4: Subjects will return for a fourth and final assessment of cotinine and carbon monoxide levels. Subjects will also complete a satisfaction questionnaire regarding their experience with using the Palm Pilot version of monitoring.
- Conditions
- Smoking
- Being tested
- Palm Pilot
- Keywords
- smoking, self-monitoring, major mental illness, palm pilots, subjects with DSM-IV Axis I diagnosis
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm PilotDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
We will compare palm-recordings with paper and pencil recordings to examine how well these correlate.
Secondary outcomes (6)
Correlations will be used to compare the total number of smoked cigarettes reported by the daily ratings (paper and pencil or palm pilot) to participants' report of their weekly totals.
We will measure the frequency at which participants access a screen on the Palm Pilot that presents the "4 D's," which are four strategies for delaying or reducing cigarette use.
Repeated measured t-tests will be used to compare participants' cotinine levels before and after participating in this program.
We will use an independent samples t-test to compare satisfaction scores for the two monitoring methods.
We will assess the degree of compliance with completing the mood rating scale (how many out of 7 were completed in the week) and will compare compliance rates for the Palm and paper-and-pencil versions using an independent samples t-test.
We will assess the amount of training time required to train participants to use either the paper and pencil or Palm Pilot versions of the monitoring form.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startJun 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants
Sponsor and investigators
- Lead sponsor
- North Suffolk Mental Health Association
- Sponsor type
- University, hospital or other
- Investigators
- Michelle Friedman-Yakoobian, Ph.D., Principal investigator, Freedom Trail Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435903
- Sponsor's protocol ID
- CORRC #21-04
- Status last verified
- Feb 2007
- First submitted
- 14 Feb 2007
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Feasibility of Palm Pilots in Monitoring Smoking Behavior in Individuals With Chronic Mental Illness
- ClinicalTrials.gov ID
- NCT00435903
- Acronym / sponsor ID
- CORRC #21-04
- Conditions
- Smoking
- Keywords
- smoking, self-monitoring, major mental illness, palm pilots, subjects with DSM-IV Axis I diagnosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants
- Lead sponsor
- North Suffolk Mental Health AssociationUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Oct 2005
- First posted
- 16 Feb 2007 (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 goal of this open trial is to pilot the use of palm pilots as a tool for monitoring smoking behavior in individuals with serious mental illness. That is, the investigators aim to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring smoking behavior and for coaching participants to use a strategy for delaying and reducing cigarette use.
Detailed description
The specific aims of this project are:
- We will compare the accuracy of daily palm pilot recordings to paper and pencil measures. We hypothesize that the number of cigarettes smoked according to daily palm pilot recordings will correlate as well with salivary cotinine levels (a metabolite of nicotine) as will daily paper and pencil recordings. That is, we expect that palm recordings will be as accurate as paper and pencil recordings.
- We will compare the total number of smoked cigarettes reported by the daily ratings (paper and pencil or palm pilot) to participants' report of their weekly totals. We expect that participants will tend to underestimate the number of cigarettes smoked when asked to report weekly totals. That is, we hypothesize that participants will report smoking fewer cigarettes in their weekly total compared to their daily reports of smoking and that totals based on daily reports will correlate more strongly with cotinine levels.
- We will measure the frequency at which participants access a screen on the Palm Pilot that presents the "4 D's," which are four strategies for delaying or reducing cigarette use. Participants will be asked to access this screen when they experience an urge to smoke. We hypothesize that at least some participants will make use of this screen.
- We will assess the effect of daily monitoring on salivary cotinine levels. Smoking reduction is not a specific goal of this program. However, participants who access the 4D's coaching screen on the Palm when they have an urge may reduce their smoking. We hypothesize that reduction in cotinine levels will be correlated with greater frequency of accessing the 4 D's screen. That is, participants who access the 4D's screen most often (more than 5 times per day) are expected to show more reduction in cotinine levels compared to baseline than are participants who do not access the 4 D's screen
- We will measure participants' level of satisfaction with the Palm Pilot and the paper and pencil versions of the monitoring forms. We hypothesize that participants will report high levels of satisfaction with the Palm Pilot version, and that these will be as high as or higher than levels of satisfaction with the paper and pencil version.
- We will assess whether participants are able to complete a rating scale on the Palm Pilot. We hypothesize that participants will be able to complete this scale.
- We will assess the amount of training time required to train participants to use either the paper and pencil or Palm Pilot versions of the monitoring form.
Methods and Procedures: Ten participants will come in for four, 45-minute assessments, for a total of 3 hours, over a 3-week period. At each visit, smoking behavior will be assessed using either the palm pilot or paper and pencil recordings and carbon monoxide and salivary cotinine will be measured. Training will be provided in the use of the palms and participants will do a "trial" recording of data before their actual data are recorded. In addition, during each week in which participants use Palm Pilots, they will be asked to come into the clinic for a mid-week visit to have their Palm Pilot charged and synced with the computer. No assessments will be completed during these mid-week visits.
Subjects will serve as their own controls in the study. Participants will be asked to keep track of their smoking and to answer questions about their smoking using two formats: paper and pencil forms and forms programmed on Palm Pilots. For the Palm Pilot recordings, participants will be loaned a Palm Pilot to use to answer questions about their smoking whenever they smoke. Palm recordings and paper and pencil recordings will be compared to salivary cotinine and carbon monoxide levels. To control for the effects of one data collection strategy being used before the other, subjects will be randomized to do either paper and pencil recordings or palm recordings first. We will also teach clients a basic behavioral strategy ("the four D's") for cutting down on the amount of cigarettes smoked. The four D's stand for 1) deep breathing, 2) drink fluids, 3) delay, and 4) do something else. The paper and Palm Pilot versions of the questionnaires will include a reminder about the four D's to encourage participants to cut down on the amount of cigarettes smoked per day. In addition, participants will be asked to fill out the Hughes-Hatsukami Scale, which is a measure of nicotine withdrawal symptoms.
In summary, all participants will take part in the following:
- Assessment 1: Baseline assessment (week 0) will include self report of cigarettes smoked in the past week, a measure of salivary cotinine level, and expired air carbon monoxide level. The four D's strategy for cutting down number of cigarettes smoked will be introduced.
- For Week 1, subjects will be asked to keep daily paper-and-pencil records of their smoking behavior for the week following baseline. Subjects will be asked to report on number of cigarettes smoked, time of day smoked, how they felt when they smoked, and the degree to which they craved the cigarette. They will also be asked to indicate whether or not they tried any of the four D's strategies to avoid or delay smoking. Additionally, they will fill out the Hughes-Hatsukami Scale once per day.
- Assessment 2: Subjects will then return for assessment at the end of the week of paper and pencil recordings. Salivary cotinine and carbon monoxide levels will be measured at this time. Additionally, subjects will fill out a satisfaction questionnaire regarding their satisfaction with the paper-and-pencil method of monitoring their smoking.
- Subjects will be trained to record their smoking behavior using a Palm Pilot version of the recording form. Subjects will be loaned a Palm Pilot that will be programmed to present a computerized version of the smoking behavior monitor form that was used to make paper and pencil recordings. Subjects will be asked to hit a button on the Palm Pilot whenever they have an urge to smoke, and to complete the recordings on the Palm Pilot in the same manner as they did with paper-and-pencil recordings. However, Palm Pilots will be set to beep 1x per day (participant's stated wake-up time) to prompt participants to make a summary recording of number of cigarettes per day and to complete the Hughes-Hatsukami Scale. Additionally, the morning questionnaire will include a reminder screen that encourages participants to make the recordings and to practice the four D's. Subjects will practice using the Palm Pilot over Week 2.
- Mid-week visit 1: Participants will return to the clinic during the middle of the week to charge and hot-sync (synchronize with the computer) their Palm Pilot. No assessments will occur during this visit.
- Assessment 3: Subjects will return after a week of practice. Salivary cotinine and carbon monoxide levels will be measured, as well as smoking withdrawal symptoms.
- Subjects will then be asked to record their smoking on the palm pilots for another week (Week 3).
- Mid-week visit 2: Participants will return to the clinic during the middle of the week to charge and hot-sync (synchronize with the computer) their Palm Pilot. No assessments will occur during this visit.
- Assessment 4: Subjects will return for a fourth and final assessment of cotinine and carbon monoxide levels. Subjects will also complete a satisfaction questionnaire regarding their experience with using the Palm Pilot version of monitoring.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 50
- Having a DSM-IV psychiatric diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, or major depression with significant functional impairment
- Smoking 10 or more cigarettes per day
- Having an expired air minimum CO of at least 10 ppm
- Normal or corrected to normal eyesight and adequate manual dexterity to operate a palm pilot (will be assessed on case by case basis with participants completing an initial screening which involves demonstrating basic ability to read the screen on the palm pilot and operate the stylus)
Key exclusion criteria (4 listed)
- Mini Mental State exam score less than 24/30
- Currently using nicotine replacement therapy
- Diagnosis of dementia, neurodegenerative disease, substance abuse or dependence disorders (to substances other than nicotine) active within the last 3 months
- Patients who, in the investigator's opinion, pose a current homicide or suicide risk
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 |
|---|---|---|
| Palm Pilot | Device | – |
Primary outcome
We will compare palm-recordings with paper and pencil recordings to examine how well these correlate.
6 secondary outcomes
Correlations will be used to compare the total number of smoked cigarettes reported by the daily ratings (paper and pencil or palm pilot) to participants' report of their weekly totals.
We will measure the frequency at which participants access a screen on the Palm Pilot that presents the "4 D's," which are four strategies for delaying or reducing cigarette use.
Repeated measured t-tests will be used to compare participants' cotinine levels before and after participating in this program.
We will use an independent samples t-test to compare satisfaction scores for the two monitoring methods.
We will assess the degree of compliance with completing the mood rating scale (how many out of 7 were completed in the week) and will compare compliance rates for the Palm and paper-and-pencil versions using an independent samples t-test.
We will assess the amount of training time required to train participants to use either the paper and pencil or Palm Pilot versions of the monitoring form.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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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.
Michelle Friedman-Yakoobian, Ph.D. principal investigator
Freedom Trail Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Palm Pilot in people with Smoking, run by North Suffolk Mental Health Association 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 4 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 18 May 2009. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
We will compare palm-recordings with paper and pencil recordings to examine how well these correlate.. 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 18 May 2009.