Effectiveness of The Health Care CEO App for T1D

NCT ID: NCT05022875

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-23

Study Completion Date

2022-07-31

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.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers
Blinding strategies include the following: (1) the statistician will not be allowed to disclose the randomization results to others; (2) after physician referral, the participant will be immediately ushered to a separate room to ensure that the caregiver does not receive information regarding the intervention content; and (3) participants of both the experimental and control groups will download the app, but app content will be different between the two groups. (4) research assistants will specially emphasize for all participants that app usage is beneficial for disease management.

Study Groups

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Experimental app intervention

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

Group Type EXPERIMENTAL

Healthcare CEO app- for experimental app intervention

Intervention Type DEVICE

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

Control app intervention

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

Group Type SHAM_COMPARATOR

Healthcare CEO app-for control app intervention

Intervention Type DEVICE

consists of 2 interfaces: CEO's profile, Health Tracking.

Interventions

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Healthcare CEO app- for experimental app intervention

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

Intervention Type DEVICE

Healthcare CEO app-for control app intervention

consists of 2 interfaces: CEO's profile, Health Tracking.

Intervention Type DEVICE

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

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Yueh-Tao Chiang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yueh-Tao Chiang, PhD

Role: STUDY_DIRECTOR

Chang Gung University

Fu-Sung Lo, BSN

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Chang-Gung University and Chang-Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yueh-Tao Chiang, PhD.

Role: CONTACT

+886-3-2118800 ext. 3866

Fu-Sung Lo, BSN

Role: CONTACT

+886-3-281200 ext. 8969

Facility Contacts

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Yueh-Tao Chiang, PhD.

Role: primary

+886-3-2118800 ext. 3866

Fu-Sung Lo, BSN

Role: backup

+886-3-281200 ext. 8969

References

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Chiang YT, Yu HY, Tsay PK, Chen CW, Chang CW, Hsu CL, Lo FS, Moons P. Effectiveness of the User-Centered "Healthcare CEO" App for Patients With Type 1 Diabetes Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 13;14:e59871. doi: 10.2196/59871.

Reference Type DERIVED
PMID: 39805107 (View on PubMed)

Other Identifiers

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ChangGungUCEOApp

Identifier Type: -

Identifier Source: org_study_id

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