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| Name | Class |
|---|---|
| Chang Gung Memorial Hospital | OTHER |
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The present study aims to evaluate the intervention effectiveness of the Healthcare Chief Executive Officer mobile application(Healthcare CEO app) in patients with type 1 diabetes transitioning from adolescence to early adulthood.
Aim:The present study aims to evaluate the intervention effectiveness of the Healthcare Chief Executive Officer mobile application in patients with type 1 diabetes transitioning from adolescence to early adulthood.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental app intervention | Experimental | The complete Healthcare CEO app will be used for intervention in the experimental group. |
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| Control app intervention | Sham Comparator | Participants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare CEO app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthcare CEO app- for experimental app intervention | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | HbA1c from baseline to 9months | Baseline and 3, 6, 9 months |
| Change in % with HbA1c <7.0% | Percentage of individuals in each group with HbA1c <7.0% | Baseline and 3, 6, 9 months |
| Change in Hyperglycemic Events | Number of events of each participant with blood sugar >200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed | Baseline and 3, 6, 9 months |
| Change in Hypoglycemic Events | Number of events of each participant with blood sugar <60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed | Baseline and 3, 6, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Diabetes Self-Management Scale score over time | Perceived Diabetes Self-Management Scale (PDSMS):The original questionnaire was developed by Wallston et al. (2007). It consists of 8 items scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree),The translated questionnaire has content validity, Cronbach's α, and test-retest reliability values of 0.75, 0.93, and 0.97, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
･ T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueh-Tao Chiang, PhD. | Contact | +886-3-2118800 | 3866 | nurs2004@gmail.com |
| Fu-Sung Lo, BSN | Contact | +886-3-281200 | 8969 | lofusu@kimo.com |
| Name | Affiliation | Role |
|---|---|---|
| Yueh-Tao Chiang, PhD | Chang Gung University | Study Director |
| Fu-Sung Lo, BSN | Chang Gung Memorial Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang-Gung University and Chang-Gung Memorial Hospital | Recruiting | Taoyuan | 33302 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39805107 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2023 | |
| Reset | Dec 13, 2023 | |
| Release | Feb 28, 2024 | |
| Unrelease | Jul 12, 2024 | |
| Release | Jul 13, 2024 | |
| Reset | Oct 9, 2024 | |
| Release | Oct 10, 2024 | |
| Reset | Nov 22, 2024 | |
| Release | Mar 18, 2026 | |
| Reset | Apr 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2023 | Dec 13, 2023 | |||
| Feb 28, 2024 | Jul 12, 2024 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Experimental group: The complete Healthcare chief executive officer app will be used for intervention in the experimental group.
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.
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Blinding strategies include the following: (1) the statistician will not be allowed to disclose the randomization results to others; (2) after physician referral, the participant will be immediately ushered to a separate room to ensure that the caregiver does not receive information regarding the intervention content; and (3) participants of both the experimental and control groups will download the app, but app content will be different between the two groups. (4) research assistants will specially emphasize for all participants that app usage is beneficial for disease management.
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| Healthcare CEO app-for control app intervention | Device | consists of 2 interfaces: CEO's profile, Health Tracking. |
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| Baseline and 3, 6, 9 months |
| Change in Self-care Behavior Assessment Scale score over time | Self-care Behavior Assessment Scale: This scale was developed by Wang (2010) to measure self-care behaviors of adolescents with T1D. A total of 39 items are scored on a 5-point Likert scale ranging from 1 (not achieved at all) to 5 (completely achieved). The total score ranges from 39 to 195, with higher scores indicating better self-care behaviors. Cronbach's α and the content validity index (CVI) value based on content rating by experts are 0.87 and 0.92, respectively. | Baseline and 3, 6, 9 months |
| Change in Diabetes Distress Scale score over time | Diabetes Distress Scale (DDS): The original scale was developed by Polonsky et al. (2005). The Chinese version consists of 18 items across four subscales. Items are scored on a 4-point Likert scale ranging from 1 (no distress) to 4 (severely distressed), with higher scores indicating more severe emotional distress. Cronbach's α and test-retest reliability values of the DDS were 0.89 and 0.81, respectively (Liu et al., 2010). | Baseline and 3, 6, 9 months |
| Change in Diabetes Quality of Life Scale score over time | Diabetes Quality of Life (DQOL): The original scale was developed for use in the Diabetes Control and Complications Trial and was translated in Chinese by Cheng et al. (1999).Higher scores are indicative of higher QOL. Cronbach's α and test-retest reliability values of the scale and subscales are within the ranges of 0.76-0.92 and 0.94-0.99, respectively. | Baseline and 3, 6, 9 months |
| Change in Diabetes Knowledge Questionnaire score over time | Diabetes Knowledge Questionnaire (DKQ): The original questionnaire was developed by Garcia et al. (2001). The Chinese version comprises 24 items that are answered "Yes," "No" or "I don't know"; 1 point is awarded for each correct answer. The total score ranges from 0 to 24 points.reliability and Cronbach's α values of 0.78 and 0.89, respectively (Hu et al., 2013) | Baseline and 3, 6, 9 months |
| Jul 13, 2024 | Oct 9, 2024 |
| Oct 10, 2024 | Nov 22, 2024 |
| Mar 18, 2026 | Apr 7, 2026 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |