- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515495
Effectiveness of Intensive Tutoring vs. Flexible Self-Learning on Digital Health Literacy and Self-Efficacy for "My Health Bank" App Use Among Adults Over 50
Effectiveness of Intensive Tutoring vs. Flexible Self-Learning on Digital Health Literacy and Self-Efficacy for "My Health Bank" App Use Among Adults Over 50: A Randomized Controlled Trial Using AI-Co-Created Materials
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is conducted over a period of 18 months (from March 1, 2026, to August 31, 2027) and is divided into three strategic phases:
Phase 1 (Months 1-6): Focuses on the development of AI-collaborative educational materials, expert validity review, and a questionnaire pre-test (n=15). A Pilot Randomized Controlled Trial (Pilot RCT, n=60) will be executed to verify the feasibility and readability of the intervention materials.
Phase 2 (Months 7-15): The formal enrollment and intervention phase. A full-scale Randomized Controlled Trial (Full-scale RCT, n=160) will be conducted using a single-blind, two-arm design. Participants will be randomly assigned to either the "Intensive Guided Learning group" or the "Flexible Self-study group," with longitudinal data collection and tracking at three time points.
Phase 3 (Months 16-18): Data processing, advanced statistical analysis (including SEM to verify empowerment mechanisms), and final manuscript preparation.
The study aims to provide empirical evidence for scalable digital health education strategies to reduce the "digital divide" among adults over 50.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu-Wen Chen, PhD student
- Phone Number: +886-922-419-022
- Email: viven0824@gmail.com
Study Locations
-
-
Anle District
-
Keelung, Anle District, Taiwan, 204
- Recruiting
- Anle District Health Center and Affiliated Community Centers
-
Contact:
- Yu-Wen Chen, PhD student
- Phone Number: +886-922-419-022
- Email: viven0824@gmail.com
-
-
Neihu District
-
Taipei, Neihu District, Taiwan, 114
- Recruiting
- Tri-Service General Hospital, Department of Orthopaedics
-
Contact:
- Yu-Wen Chen, PhD student
- Phone Number: +886-922-419-022
- Email: viven0824@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 50 years and older.
- Possession of a smartphone with basic operational skills (e.g., unlocking the phone, making calls, and using LINE).
- Self-reported lack of familiarity with the "My Health Bank" App (used less than 3 times or never used in the past year).
- Proficiency in listening, speaking, reading, and understanding Mandarin Chinese.
Exclusion Criteria:
- Regular users of the "My Health Bank" App (used 3 times or more in the past year).
- Severe cognitive impairment identified through brief cognitive screening, the participant unable to follow instructions or complete questionnaires.
- Smartphone operating system is too outdated to support the installation of the "NHI App" (National Health Insurance App).
- Inability to complete the App download and installation process independently or with family assistance (e.g., lost App Store/Google Play password, insufficient storage space).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intensive Guided Learning Group
Participants receive AI-collaborative educational materials with intensive guidance from instructors.
|
This behavioral intervention consists of a structured eHealth literacy curriculum using AI-collaborative educational materials.
The program focuses on teaching participants how to utilize the "My Health Bank" platform for personal health management.
The intervention is delivered in two formats depending on group assignment: The experimental group receives intensive instructor-led guidance and hands-on practice.
The control group engages in flexible self-study using the same AI-generated materials.
The curriculum aims to enhance digital health literacy, self-efficacy, and active engagement (measured by frequency of use) with digital health tools among older adults.
|
|
Active Comparator: Flexible Self-study Group
Participants receive the same AI-collaborative educational materials as the experimental group but engage in self-paced learning without intensive instructor-led guidance.
This group serves to evaluate the baseline effectiveness of the digital materials when used independently.
|
This behavioral intervention consists of a structured eHealth literacy curriculum using AI-collaborative educational materials.
The program focuses on teaching participants how to utilize the "My Health Bank" platform for personal health management.
The intervention is delivered in two formats depending on group assignment: The experimental group receives intensive instructor-led guidance and hands-on practice.
The control group engages in flexible self-study using the same AI-generated materials.
The curriculum aims to enhance digital health literacy, self-efficacy, and active engagement (measured by frequency of use) with digital health tools among older adults.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in eHealth Literacy Scale (eHEALS) Score
Time Frame: Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)
|
The eHealth Literacy Scale (eHEALS) is used to measure participants' combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems.
The scale contains 8 items, each scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Total scores range from 8 to 40, with higher scores indicating higher perceived eHealth literacy.
|
Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in General Self-Efficacy Scale (GSES) Score
Time Frame: Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)
|
This scale is used to assess participants' self-efficacy in managing their health and using digital tools.
It consists of 5 items, with each item scored on a 10-point scale ranging from 1 (not confident at all) to 10 (completely confident).
The total score ranges from 5 to 50.
A higher score indicates a stronger sense of self-efficacy in health management and digital tool proficiency.
|
Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)
|
|
Post-Intervention Digital Health Management Behavior
Time Frame: 4-weeks post-intervention (T2)
|
This measures the frequency and proficiency of participants' actual use of digital health tools, specifically the "My Health Bank" platform.
Depending on the questionnaire used (e.g., a self-reported health behavior frequency scale), each item is typically scored on a Likert scale.
Total scores reflect the active engagement level in digital health self-management.
Higher scores indicate more frequent and positive health-promoting behaviors.
|
4-weeks post-intervention (T2)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kun-Yi Lin, MD, PhD, Department of Orthopaedics, Tri-Service General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C202605032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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