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临床试验/NCT07515495
NCT07515495招募中不适用

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

Tri-Service General Hospital2 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2026年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
235
试验地点
2
主要终点
Change in eHealth Literacy Scale (eHEALS) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Intensive Guided Learning Group

Experimental

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

干预措施: AI-Collaborative eHealth Education (Behavioral)

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.

干预措施: AI-Collaborative eHealth Education (Behavioral)

结局指标

主要结局

Change in eHealth Literacy Scale (eHEALS) Score

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kun-Yi Lin

Chief, Division of General Orthopaedics

Tri-Service General Hospital

研究点 (2)

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