Effectiveness of The Health Care CEO App for T1D

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of the 'Healthcare CEO' App for Type 1 Diabetes Patients Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Healthcare CEO app- for experimental app intervention
* Device: Healthcare CEO app-for control app intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a confirmed diagnosis of T1D by an endocrinologist before the age of 16 and a disease duration of >6months 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: ･ T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental app intervention<br>The complete Healthcare CEO app will be used for intervention in the experimental group. | Device: Healthcare CEO app- for experimental app intervention<br>* 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<br>|
| Sham Comparator: Control app intervention<br>Participants in the control group will only install the CEO's Profile and Health Tracking interfaces of the Healthcare CEO app. | Device: Healthcare CEO app-for control app intervention<br>* consists of 2 interfaces: CEO's profile, Health Tracking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, transition, mobile health, treatment fidelity