Comparison of the Health Literacy of Our Patients Who Quit Smoking and Who Cannot Quit Smoking

May 20, 2021 updated by: Seyhan Dülger,MD, Bursa Yüksek İhtisas Education and Research Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Eyalet/Yerleşke
      • Bursa, Eyalet/Yerleşke, Turkey, 16115
        • Bursa Yuksek Ihtisas EAH

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who applied to the smoking cessation clinic for smoking cessation
  2. over the age of 18
  3. Those who agree to answer the health literacy scale form

Exclusion Criteria:

  1. Patients under the age of 18
  2. Those who do not agree to answer the health literacy scale form

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: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: quit smoking
patients who have quit smoking
Behavioral: Health literacy scale

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.
Active Comparator: not quit smoking
patients who have not quit smoking
Behavioral: Health literacy scale

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After 1 year of follow-up in the smoking cessation clinic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bursa Yüksek İhtisas Education and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seyhan Dülger, Bursa Yüksek İhtisas Education And Training Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-KAEK-25 2021/05-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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