Effectiveness of The Health Care CEO App for T1D
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Device: Healthcare CEO app-for control app interventionDevice: Healthcare CEO app- for experimental app intervention
- Registration Number
- NCT05022875
- Lead Sponsor
- Chang Gung University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 96
- 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.
･ T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control app intervention Healthcare CEO app-for control app intervention Participants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare CEO app. Experimental app intervention Healthcare CEO app- for experimental app intervention The complete Healthcare CEO app will be used for intervention in the experimental group.
- Primary Outcome Measures
Name Time Method Change in Hypoglycemic Events Baseline and 3, 6, 9 months Number of events of each participant with blood sugar \<60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed
Change in HbA1c Baseline and 3, 6, 9 months HbA1c from baseline to 9months
Change in % with HbA1c <7.0% Baseline and 3, 6, 9 months Percentage of individuals in each group with HbA1c \<7.0%
Change in Hyperglycemic Events Baseline and 3, 6, 9 months Number of events of each participant with blood sugar \>200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed
- Secondary Outcome Measures
Name Time Method Change in Perceived Diabetes Self-Management Scale score over time Baseline and 3, 6, 9 months 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.
Change in Diabetes Quality of Life Scale score over time Baseline and 3, 6, 9 months 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.
Change in Self-care Behavior Assessment Scale score over time Baseline and 3, 6, 9 months 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.
Change in Diabetes Distress Scale score over time Baseline and 3, 6, 9 months 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).
Change in Diabetes Knowledge Questionnaire score over time Baseline and 3, 6, 9 months 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)
Trial Locations
- Locations (1)
Chang-Gung University and Chang-Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan