Smoking CessationNCT04896554
Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
A study testing Health literacy scale in people with Smoking Cessation and Health Literacy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was determined to examine the relationship between the health literacy scales of the patients who came to the smoking cessation clinic and their smoking cessation success. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Health Literacy
- What is being tested?
- Health literacy scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 7 May 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who applied to the smoking cessation clinic for smoking cessation
- over the age of 18
- Those who agree to answer the health literacy scale form
Who cannot join
- Patients under the age of 18
- Those who do not agree to answer the health literacy scale form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas EAH
Bursa, Eyalet/Yerleşke, 16115
About this study
The aim of the study was determined to examine the relationship between the health literacy scales of the patients who came to the smoking cessation clinic and their smoking cessation success.
The patient follow-up files registered in the archive of the smoking cessation clinic will be scanned for the last 2 years and the demographic data and follow-up information of the patients will be reached. Patients who have completed the 1-year follow-up period will be contacted by phone, questioning whether they smoke or not, and will be invited to answer the health literacy scale. Accepting patients will be divided into two groups as those who quit smoking and those who cannot, and health literacy scales will be compared.
- Conditions
- Smoking Cessation, Health Literacy
- Being tested
- Health literacy scale
- Keywords
- smoking cessation, health literacy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy scaleBehavioural
The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression "I don't know". The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50.
Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy.
| Study group | Role | What they receive |
|---|---|---|
| quit smoking | Active comparator | patients who have quit smoking Receives: Behavioral: Health literacy scale |
| not quit smoking | Active comparator | patients who have not quit smoking Receives: Behavioral: Health literacy scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy
The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression "I don't know". The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50.
Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy.
Measured: After 1 year of follow-up in the smoking cessation clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 May 2021
- Primary completion1 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seyhan Dülger,MD, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Seyhan Dülger, Principal investigator, Bursa Yüksek İhtisas Education And Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896554
- Sponsor's protocol ID
- 2011-KAEK-25 2021/05-01
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking
- ClinicalTrials.gov ID
- NCT04896554
- Acronym / sponsor ID
- 2011-KAEK-25 2021/05-01
- Conditions
- Smoking Cessation, Health Literacy
- Keywords
- smoking cessation, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 21 May 2021 (actual)
- 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 aim of the study was determined to examine the relationship between the health literacy scales of the patients who came to the smoking cessation clinic and their smoking cessation success.
The patient follow-up files registered in the archive of the smoking cessation clinic will be scanned for the last 2 years and the demographic data and follow-up information of the patients will be reached. Patients who have completed the 1-year follow-up period will be contacted by phone, questioning whether they smoke or not, and will be invited to answer the health literacy scale. Accepting patients will be divided into two groups as those who quit smoking and those who cannot, and health literacy scales will be compared.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quit smoking | Active comparator | Behavioral: Health literacy scalepatients who have quit smoking |
| not quit smoking | Active comparator | Behavioral: Health literacy scalepatients who have not quit smoking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who applied to the smoking cessation clinic for smoking cessation
- over the age of 18
- Those who agree to answer the health literacy scale form
Key exclusion criteria (2 listed)
- Patients under the age of 18
- Those who do not agree to answer the health literacy scale form
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 |
|---|---|---|
| Health literacy scaleThe Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression "I don't know". The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50. Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy. | Behavioural | not quit smoking, quit smoking |
Primary outcome
Health literacy
Time frame: After 1 year of follow-up in the smoking cessation clinic
The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression "I don't know". The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50. Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy.
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 May 2021.
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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.
Seyhan Dülger principal investigator
Bursa Yüksek İhtisas Education And Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health literacy scale in people with Smoking Cessation and Health Literacy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 May 2021. 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 Turkey (Türkiye). 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?
Health literacy (time frame: After 1 year of follow-up in the smoking cessation clinic). 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 21 May 2021.