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

Sponsor
Akdeniz University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05831254
Collaborator
(none)
140
2
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Health education:Interactive group training
  • Other: Health education: Individually training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jun 2, 2023
Anticipated Primary Completion Date :
Sep 2, 2023
Anticipated Study Completion Date :
Dec 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HEalth Literacy, e-Pulse (HELP)

Other: Health education:Interactive group training
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.

Active Comparator: e-Pulse

Other: Health 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.

Outcome Measures

Primary Outcome Measures

  1. European Health Literacy Scale [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.

Secondary Outcome Measures

  1. eHealth Literacy Scale [Baseline-Second month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being aged 45-64 and above and being literate,

  • Having a score of 42 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:

• Those who do not speak Turkish

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sebahat Gozum, Prof.Dr.Sebahat Gozum, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05831254
Other Study ID Numbers:
  • 003
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 26, 2023