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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05831254
Other study ID # 003
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2, 2023
Est. completion date December 2, 2023

Study information

Verified date April 2023
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date December 2, 2023
Est. primary completion date September 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Baseline-Second month
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