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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
96
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
consists of 2 interfaces: CEO's profile, Health Tracking.
Chang-Gung University and Chang-Gung Memorial Hospital
Taoyuan District, Taiwan
RECRUITINGChange in HbA1c
HbA1c from baseline to 9months
Time frame: Baseline and 3, 6, 9 months
Change in % with HbA1c <7.0%
Percentage of individuals in each group with HbA1c \<7.0%
Time frame: 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
Time frame: 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
Time frame: Baseline and 3, 6, 9 months
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.
Time frame: 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.
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Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: Baseline and 3, 6, 9 months