Digital Health LiteracyNCT07515495
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 study testing AI-Collaborative eHealth Education in people with Digital Health Literacy and Healthy Aging, run by Tri-Service General Hospital (TSGH) at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Digital Health Literacy, Healthy Aging
- What is being tested?
- AI-Collaborative eHealth Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesTaiwan
- Study dates
- 2 Apr 2026to 9 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Anle District Health Center and Affiliated Community Centers
Keelung, Anle District, 204
Yu-Wen Chen, PhD student, +886-922-419-022, viven0824@gmail.com
- Recruiting
Tri-Service General Hospital, Department of Orthopaedics
Taipei, Neihu District, 114
Yu-Wen Chen, PhD student, +886-922-419-022, viven0824@gmail.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Digital Health Literacy, Healthy Aging
- Being tested
- AI-Collaborative eHealth Education
- Keywords
- eHealth Literacy, Health Self-Efficacy, My Health Bank, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Collaborative eHealth EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Guided Learning Group | Experimental | Participants receive AI-collaborative educational materials with intensive guidance from instructors. Receives: 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. Receives: Behavioral: AI-Collaborative eHealth Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)
Secondary outcomes (2)
Change in General Self-Efficacy Scale (GSES) Score
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.
Measured: Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)
Post-Intervention Digital Health Management Behavior
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.
Measured: 4-weeks post-intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start2 Apr 2026
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Yi Lin, Tri-Service General Hospital (TSGH)
- Investigators
- Kun-Yi Lin, MD, PhD, Principal investigator, Department of Orthopaedics, Tri-Service General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515495
- Sponsor's protocol ID
- C202605032
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and maintain data confidentiality according to the approved IRB protocol.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07515495
- Acronym / sponsor ID
- C202605032
- Conditions
- Digital Health Literacy, Healthy Aging
- Keywords
- eHealth Literacy, Health Self-Efficacy, My Health Bank, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Mar 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intensive Guided Learning Group | Experimental | Behavioral: AI-Collaborative eHealth EducationParticipants receive AI-collaborative educational materials with intensive guidance from instructors. |
| Flexible Self-study Group | Active comparator | Behavioral: AI-Collaborative eHealth EducationParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Collaborative eHealth EducationThis 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. | Behavioural | Flexible Self-study Group, Intensive Guided Learning Group |
Primary outcome
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.
2 secondary outcomes
Change in General Self-Efficacy Scale (GSES) Score
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. To protect participant privacy and maintain data confidentiality according to the approved IRB protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kun-Yi Lin, MD, PhD principal investigator
Department of Orthopaedics, Tri-Service General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Collaborative eHealth Education in people with Digital Health Literacy and Healthy Aging, run by Tri-Service General Hospital (TSGH) at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Wen Chen, PhD Student (+886-922-419-022, viven0824@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eHealth Literacy Scale (eHEALS) Score (time frame: Baseline (T0), 1-week post-intervention (T1), and 4-weeks post-intervention (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.