Effectiveness of The Health Care CEO App for T1D

Chang Gung University

Status: Unknown

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Healthcare CEO app-for control app intervention; Device: Healthcare CEO app- for experimental app intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05022875

ChangGungUCEOApp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 16 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Experimental app intervention

Experimental group

Description:

The complete Healthcare CEO app will be used for intervention in the experimental group.

Treatment:

Device: Healthcare CEO app- for experimental app intervention

Control app intervention

Sham Comparator group

Description:

Participants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare CEO app.

Treatment:

Device: Healthcare CEO app-for control app intervention