Effectiveness of The Health Care CEO App for T1D
Effectiveness of the 'Healthcare CEO' App for Type 1 Diabetes Patients Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2021
CompletedFirst Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedAugust 26, 2021
August 1, 2021
1.3 years
August 20, 2021
August 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in HbA1c
HbA1c from baseline to 9months
Baseline and 3, 6, 9 months
Change in % with HbA1c <7.0%
Percentage of individuals in each group with HbA1c \<7.0%
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
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
Baseline and 3, 6, 9 months
Secondary Outcomes (5)
Change in Perceived Diabetes Self-Management Scale score over time
Baseline and 3, 6, 9 months
Change in Self-care Behavior Assessment Scale score over time
Baseline and 3, 6, 9 months
Change in Diabetes Distress Scale score over time
Baseline and 3, 6, 9 months
Change in Diabetes Quality of Life Scale score over time
Baseline and 3, 6, 9 months
Change in Diabetes Knowledge Questionnaire score over time
Baseline and 3, 6, 9 months
Study Arms (2)
Experimental app intervention
EXPERIMENTALThe complete Healthcare CEO app will be used for intervention in the experimental group.
Control app intervention
SHAM COMPARATORParticipants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare CEO app.
Interventions
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.
Eligibility Criteria
You may qualify if:
- a confirmed diagnosis of T1D by an endocrinologist before the age of 16 and a disease duration of \>6months
- patients aged 16-25 years
- 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.
You may not qualify if:
- ･ T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang Gung Universitylead
- Chang Gung Memorial Hospitalcollaborator
Study Sites (1)
Chang-Gung University and Chang-Gung Memorial Hospital
Taoyuan District, 33302, Taiwan
Related Publications (1)
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.
PMID: 39805107DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yueh-Tao Chiang, PhD
Chang Gung University
- STUDY DIRECTOR
Fu-Sung Lo, BSN
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- 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.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 20, 2021
First Posted
August 26, 2021
Study Start
April 23, 2021
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
August 26, 2021
Record last verified: 2021-08