Clinical trial NCT05022875: Effectiveness of The Health Care CEO App for T1D
Official title: Effectiveness of the 'Healthcare CEO' App for Type 1 Diabetes Patients Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes
transition
mobile health
treatment fidelity
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2021-08-26
Enrollment: 96
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline and 3, 6, 9 months
measure: Change in % with HbA1c <7.0%
timeFrame: Baseline and 3, 6, 9 months
measure: Change in Hyperglycemic Events
timeFrame: Baseline and 3, 6, 9 months
measure: Change in Hypoglycemic Events
timeFrame: Baseline and 3, 6, 9 months
Secondary outcomes:
measure: Change in Perceived Diabetes Self-Management Scale score over time
timeFrame: Baseline and 3, 6, 9 months
measure: Change in Self-care Behavior Assessment Scale score over time
timeFrame: Baseline and 3, 6, 9 months
measure: Change in Diabetes Distress Scale score over time
timeFrame: Baseline and 3, 6, 9 months
measure: Change in Diabetes Quality of Life Scale score over time
timeFrame: Baseline and 3, 6, 9 months
measure: Change in Diabetes Knowledge Questionnaire score over time
timeFrame: Baseline and 3, 6, 9 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang-Gung University and Chang-Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Yueh-Tao Chiang, PhD
role: STUDY_DIRECTOR
affiliation: Chang Gung Memorial Hospital
name: Fu-Sung Lo, BSN
role: STUDY_DIRECTOR
References: