Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2021-04-23
2022-07-31
Brief Summary
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Detailed Description
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Design: A 9-month two-arm, parallel-group, single-blind, randomized controlled trial Methods: Ninety-six Type-1 diabetes patients, aged 16-25 years, are expected to participate in this study. Participants will be randomly assigned to the experimental or control group by central randomization. The Healthcare Chief Executive Officer app, which consists of the following functions: data recording, knowledge, communication skills, food swap guide, exercise recommendations, chatroom, reminders, and SOS, will be used as the intervention measure. We will compare the differences in disease control outcomes, confidence in self-management, self-care behaviors, emotional distress, quality of life, and specific diabetes-related knowledge between the two groups before intervention and at 3, 6, and, 9 months post-intervention. The differences within the experimental group pre- and post- intervention will also be analyzed. This study design was approved by the ethics committee of the researcher's affiliation in March 2021.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Control Group: Participants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare chief executive officer app.
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Experimental app intervention
The complete Healthcare CEO app will be used for intervention in the experimental group.
Healthcare CEO app- for experimental app intervention
The app content was designed based on the results of previous qualitative and Delphi studies (Chiang et al., 2021; Chiang et al., 2020) and consists of 11 interfaces: CEO's profile, Health Tracking, CEO Knowledge Base, Barrier-free Communication, See Here: Diet and Exercise, Help Me, Detective!, CEO Chatroom, CEO's Secretary, Who's the Best CEO, SOS Calls, and Q\&A
Control app intervention
Participants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare CEO app.
Healthcare CEO app-for control app intervention
consists of 2 interfaces: CEO's profile, Health Tracking.
Interventions
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Healthcare CEO app- for experimental app intervention
The app content was designed based on the results of previous qualitative and Delphi studies (Chiang et al., 2021; Chiang et al., 2020) and consists of 11 interfaces: CEO's profile, Health Tracking, CEO Knowledge Base, Barrier-free Communication, See Here: Diet and Exercise, Help Me, Detective!, CEO Chatroom, CEO's Secretary, Who's the Best CEO, SOS Calls, and Q\&A
Healthcare CEO app-for control app intervention
consists of 2 interfaces: CEO's profile, Health Tracking.
Eligibility Criteria
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Inclusion Criteria
* patients aged 16-25 years
* mean HbA1C level ≥7.5% one year before inclusion
* ability to communicate in Chinese or Mandarin
* patients who own smartphones with internet access
* patients who agreed to voice recording during a session explaining the treatment process
* patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.
Exclusion Criteria
16 Years
25 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Chang Gung University
OTHER
Responsible Party
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Yueh-Tao Chiang
Assistant Professor
Principal Investigators
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Yueh-Tao Chiang, PhD
Role: STUDY_DIRECTOR
Chang Gung University
Fu-Sung Lo, BSN
Role: STUDY_DIRECTOR
Chang Gung Memorial Hospital
Locations
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Chang-Gung University and Chang-Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Chiang YT, Yu HY, Tsay PK, Chen CW, Chang CW, Hsu CL, Lo FS, Moons P. Effectiveness of the User-Centered "Healthcare CEO" App for Patients With Type 1 Diabetes Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 13;14:e59871. doi: 10.2196/59871.
Other Identifiers
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ChangGungUCEOApp
Identifier Type: -
Identifier Source: org_study_id
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