NCT07515495

Brief Summary

The purpose of this study is to evaluate the effectiveness of two different educational models in improving the use of the "My Health Bank" App (a Personal Health Record system in Taiwan) among adults aged 50 and older. As Taiwan's population ages, digital health management has become essential, yet older adults often face a "digital divide." Participants will be randomly assigned to either a "Intensive Guided Learning group" (receiving one-on-one human instruction) or a "Flexible Self-study group" (using self-learning materials co-created with Generative AI). The study aims to compare the outcomes of these two groups in terms of enhancing digital health literacy, self-efficacy, and actual App usage behavior to identify more effective and scalable digital health education strategies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

March 31, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 2, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

March 31, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

eHealth LiteracyHealth Self-EfficacyMy Health BankRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Change in eHealth Literacy Scale (eHEALS) Score

    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 Outcomes (2)

  • Change in General Self-Efficacy Scale (GSES) Score

    Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)

  • Post-Intervention Digital Health Management Behavior

    4-weeks post-intervention (T2)

Study Arms (2)

Intensive Guided Learning Group

EXPERIMENTAL

Participants receive AI-collaborative educational materials with intensive guidance from instructors.

Behavioral: AI-Collaborative eHealth Education

Flexible Self-study Group

ACTIVE COMPARATOR

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.

Behavioral: AI-Collaborative eHealth Education

Interventions

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.

Flexible Self-study GroupIntensive Guided Learning Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anle District Health Center and Affiliated Community Centers

Keelung, Anle District, 204, Taiwan

RECRUITING

Tri-Service General Hospital, Department of Orthopaedics

Taipei, Neihu District, 114, Taiwan

RECRUITING

Study Officials

  • Kun-Yi Lin, MD, PhD

    Department of Orthopaedics, Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Wen Chen, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a single-blind study where the outcomes assessors are kept masked to the group assignments during data collection and statistical analysis to minimize bias.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study is conducted in sequential phases. Following a pre-test (n=15) for tool validation and a Pilot Randomized Controlled Trial (n=60) to evaluate feasibility, the Full-scale RCT (n=160) employs a single-blind, two-arm parallel design. Participants in the full-scale trial are randomly assigned to either the "Intensive Guided Learning Group" or the "Flexible Self-study Group." Data collection occurs at three time points: baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2). To ensure data independence, participants from the pre-test and pilot stages will be excluded from the final full-scale RCT analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of General Orthopaedics

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

April 2, 2026

Primary Completion (Estimated)

March 9, 2027

Study Completion (Estimated)

March 9, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

To protect participant privacy and maintain data confidentiality according to the approved IRB protocol.

Locations