NCT05831254

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2025

Completed
Last Updated

February 5, 2025

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 14, 2023

Last Update Submit

February 3, 2025

Conditions

Outcome Measures

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.

    Baseline-Second month

Secondary Outcomes (1)

  • eHealth Literacy Scale

    Baseline-Second month

Study Arms (2)

HEalth Literacy, e-Pulse (HELP)

EXPERIMENTAL
Other: Health education:Interactive group training

e-Pulse

ACTIVE COMPARATOR
Other: Health education: Individually training

Interventions

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.

HEalth Literacy, e-Pulse (HELP)

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.

e-Pulse

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who do not speak Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soğuksu Yaşlı Evi

Antalya, Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.Sebahat Gozum

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 26, 2023

Study Start

October 2, 2023

Primary Completion

December 30, 2023

Study Completion

February 3, 2025

Last Updated

February 5, 2025

Record last verified: 2024-04

Locations