Health LiteracyHELP-e-PulseNCT05831254
The Effect of Health Literacy Education in Adults (HELP-e-Pulse)
A study testing Health education:Interactive group training and Health education: Individually training in people with Health Literacy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The world's elderly population is increasing. It is possible to prepare for the old age period by starting to develop the level of Health Literacy (HL) in the 45-64 age group. In this context, this study is planned to be conducted as a randomized controlled study with an active control group in order to compare the… Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy
- What is being tested?
- Health education:Interactive group training and Health education: Individually training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 3 Feb 2025
- 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 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being aged 45-64 and above and being literate,
- Having a score of 33 or less on the European Health Literacy Scale (insufficient, limited and problematic health literacy)
- Being able to use a smart phone, tablet or computer,
- Having agreed to voluntarily participate in the study.
Who cannot join
- Those who do not speak Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of European Health Literacy Based Education and E-Pulse Education on the Level of Health Literacy in Adults Aged 45-64: a Randomized Controlled Study with Active Control Group
The world's elderly population is increasing. It is possible to prepare for the old age period by starting to develop the level of Health Literacy (HL) in the 45-64 age group. In this context, this study is planned to be conducted as a randomized controlled study with an active control group in order to compare the effect of European Health Literacy-based education and e-Pulse education (HELP) on the level of health literacy in adults aged 45-64 with insufficient-limited health literacy. The study was planned to include a total of 140 participants from the intervention group (HELP) (n:70) and the active control group (e-Pulse) (n:70). Interactive group training consisting of six modules and 90 minutes each will be given to the HELP group. Individual e-Pulse instruction will be given to the active control group. European Health Literacy Scale scores will be considered as the primary outcome of the research. Scores from the eHealth Literacy Scale will be considered as the secondary outcome of the research.
- Conditions
- Health Literacy
- Being tested
- Health education:Interactive group training, Health education: Individually training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education:Interactive group trainingOther
- To introduce e-pulse software, which is a personal health record system, to show its use, to provide training materials such as video-brochures about e-pulse. This program will be done as interactive group training
- Six modular interactive group training, each of which includes the steps of the European Health Literacy Scale of 90 minutes.
Health education: Individually trainingOther
To introduce e-pulse software, which is a personal health record system, to provide training materials such as video-brochures about e-pulse. This education will be done individually.
| Study group | Role | What they receive |
|---|---|---|
| HEalth Literacy, e-Pulse (HELP) | Experimental | Not described Receives: Other: Health education:Interactive group training |
| e-Pulse | Active comparator | Not described Receives: Other: Health education: Individually training |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Health Literacy Scale
This scale is a self-report measure used to evaluate the health literacy level for individuals over 15 years old. It includes three topics (treatment, prevention from diseases and improving health) and 47 items. Each item has four possible answers: 1 = Very difficult, 2 = Difficult, 3 = Easy and 4 = Very easy. A 'Don't know' answer is coded as 5. Health literacy level is evaluated in four categories according to the score obtained: (0-25) points: insufficient health literacy; (>25-33) : problematic - limited health literacy; (>33-42) : adequate health literacy; (>42-50) : indicates excellent health literacy.
Measured: Baseline-Second month
Secondary outcomes (1)
eHealth Literacy Scale
The eHEALS is an 8-item measure of eHealth literacy developed to measure consumers' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems.
Measured: Baseline-Second month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start2 Oct 2023
- Primary completion30 Dec 2023
- Study completion3 Feb 2025
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 LiteracyStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Gozum, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831254
- Sponsor's protocol ID
- 003
- Acronym
- HELP-e-Pulse
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gozum S, Asi E, Siklaroglu M, Sahin S, Oncel S, Imamoglu D, Kanli S. The Effect of European Health Literacy-Based e-Pulse Education and e-Pulse Instructional Materials on Health Literacy Levels in Adults Aged 45-64: A Randomized Controlled Trial. Res Nurs Health. 2025 Jun;48(3):324-336. doi: 10.1002/nur.22450. Epub 2025 Jan 30.
PubMed 39887466
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of European Health Literacy Based Education and E-Pulse Education on the Level of Health Literacy in Adults Aged 45-64: a Randomized Controlled Study with Active Control Group
- ClinicalTrials.gov ID
- NCT05831254
- Acronym / sponsor ID
- HELP-e-Pulse / 003
- Conditions
- Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 26 Apr 2023 (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 world's elderly population is increasing. It is possible to prepare for the old age period by starting to develop the level of Health Literacy (HL) in the 45-64 age group. In this context, this study is planned to be conducted as a randomized controlled study with an active control group in order to compare the effect of European Health Literacy-based education and e-Pulse education (HELP) on the level of health literacy in adults aged 45-64 with insufficient-limited health literacy. The study was planned to include a total of 140 participants from the intervention group (HELP) (n:70) and the active control group (e-Pulse) (n:70). Interactive group training consisting of six modules and 90 minutes each will be given to the HELP group. Individual e-Pulse instruction will be given to the active control group. European Health Literacy Scale scores will be considered as the primary outcome of the research. Scores from the eHealth Literacy Scale will be considered as the secondary outcome of the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEalth Literacy, e-Pulse (HELP) | Experimental | Other: Health education:Interactive group training |
| e-Pulse | Active comparator | Other: Health education: Individually training |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being aged 45-64 and above and being literate,
- Having a score of 33 or less on the European Health Literacy Scale (insufficient, limited and problematic health literacy)
- Being able to use a smart phone, tablet or computer,
- Having agreed to voluntarily participate in the study.
Key exclusion criteria (1 listed)
- Those who do not speak Turkish
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 education:Interactive group training1. To introduce e-pulse software, which is a personal health record system, to show its use, to provide training materials such as video-brochures about e-pulse. This program will be done as interactive group training 2. Six modular interactive group training, each of which includes the steps of the European Health Literacy Scale of 90 minutes. | Other | HEalth Literacy, e-Pulse (HELP) |
| Health education: Individually trainingTo introduce e-pulse software, which is a personal health record system, to provide training materials such as video-brochures about e-pulse. This education will be done individually. | Other | e-Pulse |
Primary outcome
European Health Literacy Scale
Time frame: Baseline-Second month
This scale is a self-report measure used to evaluate the health literacy level for individuals over 15 years old. It includes three topics (treatment, prevention from diseases and improving health) and 47 items. Each item has four possible answers: 1 = Very difficult, 2 = Difficult, 3 = Easy and 4 = Very easy. A 'Don't know' answer is coded as 5. Health literacy level is evaluated in four categories according to the score obtained: (0-25) points: insufficient health literacy; (>25-33) : problematic - limited health literacy; (>33-42) : adequate health literacy; (>42-50) : indicates excellent health literacy.
1 secondary outcome
eHealth Literacy Scale
Time frame: Baseline-Second month
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 5 Feb 2025.
- Derived from this study: PubMed 39887466Gozum S, Asi E, Siklaroglu M, Sahin S, Oncel S, Imamoglu D, Kanli S. The Effect of European Health Literacy-Based e-Pulse Education and e-Pulse Instructional Materials on Health Literacy Levels in Adults Aged 45-64: A Randomized Controlled Trial. Res Nurs Health. 2025 Jun;48(3):324-336. doi: 10.1002/nur.22450. Epub 2025 Jan 30.
- Individual participant dataSharing planned: Undecided
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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 education:Interactive group training and Health education: Individually training in people with Health Literacy, run by Akdeniz University 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 1 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 5 Feb 2025. 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?
European Health Literacy Scale (time frame: Baseline-Second month). 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 NCT05831254, 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 5 Feb 2025.