Health Literacy LevelHLNCT04868487
Effectiveness of Health Literacy Education
A study testing Health Literacy Education in people with Health Literacy Level, run by Ayşegül Akca at 1 site in Turkey (Türkiye).
Trial summary
To determine the effect of health literacy education given to nursing students. The study was conducted at two university nursing departments in Turkey between December 2018 and March 2019. A total of 206 nursing students, 103 in the intervention and 103 in the control group, were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy Level
- What is being tested?
- Health Literacy Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 15 May 2019
- 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 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inadequate (0-25 points) health literacy level
- Problematic-limited (25-33 points) health literacy level
- Accepting to participate in the research
- Accepting to participate in the research
Who cannot join
- Adequate (33-42 points) health literacy level
- Excellent (42-50 points) health literacy level
- Foreign language students with limited language proficiency
- Visual-hearing disability
- Having a neuropsychiatric disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, Çubuk, 06760
About this study
Official title: Effectiveness of Health Literacy Education for Nursing Students in Turkey
To determine the effect of health literacy education given to nursing students. The study was conducted at two university nursing departments in Turkey between December 2018 and March 2019. A total of 206 nursing students, 103 in the intervention and 103 in the control group, were included in the study. Health literacy education, consisting of four sessions, was given to the intervention group.
- Conditions
- Health Literacy Level
- Being tested
- Health Literacy Education
- Keywords
- health literacy, nursing education, undergraduate student, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy EducationOther
Health literacy education, consisting of four sessions, was given to the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group received four weekly training sessions of health literacy education. Each educational session lasted an average of 50 minutes. The students were divided into four groups with an average of 25 students in each group. Receives: Other: Health Literacy Education |
| Control | No intervention | The control group had no educational interaction with the researcher after the pre-test. The control group was administered the one-week and three-month posttest THLS-32 by the researcher simultaneously with the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
The level of health literacy was evaluated in four categories according to the score obtained: (0-25) points: inadequate health literacy, (> 25-33) points: problematic - limited health literacy, (> 33-42) points: adequate health literacy, and (> 42-50) points: excellent health literacy. The health literacy level of the students was determined and the intervention and control group was selected from among the students with insufficient and problematic-limited health literacy level.
Measured: before the implementation
Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
The health literacy levels of the students who received and did not receive the intervention were compared. The level of health literacy was evaluated in four categories according to the score obtained: (0-25) points: inadequate health literacy, (> 25-33) points: problematic - limited health literacy, (> 33-42) points: adequate health literacy, and (> 42-50) points: excellent health literacy.
Measured: one week after the implementation
Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
The health literacy levels of the students who received and did not receive the intervention were compared. The level of health literacy was evaluated in four categories according to the score obtained: (0-25) points: inadequate health literacy, (> 25-33) points: problematic - limited health literacy, (> 33-42) points: adequate health literacy, and (> 42-50) points: excellent health literacy.
Measured: three months after the implementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Dec 2018
- Primary completion31 Mar 2019
- Study completion15 May 2019
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 Health Literacy LevelStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşegül Akca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşegül Akca, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868487
- Sponsor's protocol ID
- 2018-455
- Acronym
- HL
- Status last verified
- May 2021
- First submitted
- 24 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akca A, Ayaz-Alkaya S. Effectiveness of health literacy education for nursing students: A randomized controlled trial. Int J Nurs Pract. 2021 Oct;27(5):e12981. doi: 10.1111/ijn.12981. Epub 2021 Jun 1.
PubMed 34060169
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Literacy Education for Nursing Students in Turkey
- ClinicalTrials.gov ID
- NCT04868487
- Acronym / sponsor ID
- HL / 2018-455
- Conditions
- Health Literacy Level
- Keywords
- health literacy, nursing education, undergraduate student, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Ayşegül AkcaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 3 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.
To determine the effect of health literacy education given to nursing students. The study was conducted at two university nursing departments in Turkey between December 2018 and March 2019. A total of 206 nursing students, 103 in the intervention and 103 in the control group, were included in the study. Health literacy education, consisting of four sessions, was given to the intervention group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Health Literacy EducationThe intervention group received four weekly training sessions of health literacy education. Each educational session lasted an average of 50 minutes. The students were divided into four groups with an average of 25 students in each group. |
| Control | No intervention | –The control group had no educational interaction with the researcher after the pre-test. The control group was administered the one-week and three-month posttest THLS-32 by the researcher simultaneously with the intervention group. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Inadequate (0-25 points) health literacy level
- Problematic-limited (25-33 points) health literacy level
- Accepting to participate in the research
- Accepting to participate in the research
Key exclusion criteria (5 listed)
- Adequate (33-42 points) health literacy level
- Excellent (42-50 points) health literacy level
- Foreign language students with limited language proficiency
- Visual-hearing disability
- Having a neuropsychiatric disease
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 EducationHealth literacy education, consisting of four sessions, was given to the intervention group. | Other | Intervention |
Primary outcome
Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
Time frame: before the implementation
The level of health literacy was evaluated in four categories according to the score obtained: (0-25) points: inadequate health literacy, (> 25-33) points: problematic - limited health literacy, (> 33-42) points: adequate health literacy, and (> 42-50) points: excellent health literacy. The health literacy level of the students was determined and the intervention and control group was selected from among the students with insufficient and problematic-limited health literacy level.
Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
Time frame: one week after the implementation
The health literacy levels of the students who received and did not receive the intervention were compared. The level of health literacy was evaluated in four categories according to the score obtained: (0-25) points: inadequate health literacy, (> 25-33) points: problematic - limited health literacy, (> 33-42) points: adequate health literacy, and (> 42-50) points: excellent health literacy.
Health literacy level (the Turkey's Health Literacy Scale (THLS-32))
Time frame: three months after the implementation.
The health literacy levels of the students who received and did not receive the intervention were compared. The level of health literacy was evaluated in four categories according to the score obtained: (0-25) points: inadequate health literacy, (> 25-33) points: problematic - limited health literacy, (> 33-42) points: adequate health literacy, and (> 42-50) points: excellent 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 6 May 2021.
- Derived from this study: PubMed 34060169Akca A, Ayaz-Alkaya S. Effectiveness of health literacy education for nursing students: A randomized controlled trial. Int J Nurs Pract. 2021 Oct;27(5):e12981. doi: 10.1111/ijn.12981. Epub 2021 Jun 1.
- Individual participant dataSharing planned: No
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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 Health Literacy Education in people with Health Literacy Level, run by Ayşegül Akca 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 4 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 6 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 level (the Turkey's Health Literacy Scale (THLS-32)) (time frame: before the implementation). The study lists 3 primary outcomes in all. 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 NCT04868487, 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 6 May 2021.