CClinicalTrials.gg
CompletedNCT05831254HELP-e-PulseUpdated Feb 5, 2025

The Effect of Health Literacy Education in Adults (HELP-e-Pulse)

An interventional study of Health education:Interactive group training and Health education: Individually training in Health Literacy, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Akdeniz University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Health Literacy
03

In context

Lead sponsor

Akdeniz University is the lead sponsor of 290 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Those who do not speak Turkish
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    HEalth Literacy, e-Pulse (HELP)

    Other: Health education:Interactive group training

  • Active comparator
    e-Pulse

    Other: Health education: Individually training

Interventions

  • OtherHealth education:Interactive group training

    1. 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.

  • OtherHealth education: Individually training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline-Second month

07

Study locations

1 site
  • Soğuksu Yaşlı Evi
    Antalya, 07058, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05831254
Lead sponsor
Akdeniz University
Responsible party
Sebahat Gozum (Prof.Dr.Sebahat Gozum, Akdeniz University) — Principal investigator
First posted
Apr 26, 2023
Start date
Oct 2, 2023
Primary completion
Dec 30, 2023
Completion
Feb 3, 2025
Last update
Feb 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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