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Type 1 Diabetes MellitusNCT05022875

Effectiveness of The Health Care CEO App for T1D

A study testing Healthcare CEO app- for experimental app intervention in people with Type 1 Diabetes Mellitus, run by Chang Gung University at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 25 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Healthcare CEO app- for experimental app intervention
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteTaiwan
Study dates
23 Apr 2021to 31 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • ･ T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.

Trial locations and contacts

1 site in 1 country.

Yueh-Tao Chiang, PhD. contact

+886-3-2118800 ext. 3866

nurs2004@gmail.com

Fu-Sung Lo, BSN contact

+886-3-281200 ext. 8969

lofusu@kimo.com

Taiwan1 site, 1 recruiting

  • Chang-Gung University and Chang-Gung Memorial Hospital

    Taoyuan, 33302

    Yueh-Tao Chiang, PhD., +886-3-2118800 ext. 3866, nurs2004@gmail.com

    Fu-Sung Lo, BSN, +886-3-281200 ext. 8969, lofusu@kimo.com

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Healthcare CEO app- for experimental app intervention, Healthcare CEO app-for control app intervention
Keywords
Type 1 Diabetes, transition, mobile health, treatment fidelity
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthcare CEO app- for experimental app interventionDevice

    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

  • Healthcare CEO app-for control app interventionDevice

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

Study groups in NCT05022875
Study groupRoleWhat they receive
Experimental app interventionExperimentalThe complete Healthcare CEO app will be used for intervention in the experimental group.
Receives: Device: Healthcare CEO app- for experimental app intervention
Control app interventionSham comparatorParticipants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare CEO app.
Receives: Device: Healthcare CEO app-for control app intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    HbA1c from baseline to 9months

    Measured: Baseline and 3, 6, 9 months

  2. Change in % with HbA1c <7.0%

    Percentage of individuals in each group with HbA1c <7.0%

    Measured: Baseline and 3, 6, 9 months

  3. Change in Hyperglycemic Events

    Number of events of each participant with blood sugar >200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed

    Measured: Baseline and 3, 6, 9 months

  4. Change in Hypoglycemic Events

    Number of events of each participant with blood sugar <60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed

    Measured: Baseline and 3, 6, 9 months

Secondary outcomes (5)

  1. Change in Perceived Diabetes Self-Management Scale score over time

    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.

    Measured: Baseline and 3, 6, 9 months

  2. Change in Self-care Behavior Assessment Scale score over time

    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.

    Measured: Baseline and 3, 6, 9 months

  3. Change in Diabetes Distress Scale score over time

    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).

    Measured: Baseline and 3, 6, 9 months

  4. Change in Diabetes Quality of Life Scale score over time

    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.

    Measured: Baseline and 3, 6, 9 months

  5. Change in Diabetes Knowledge Questionnaire score over time

    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)

    Measured: Baseline and 3, 6, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2021
  2. Study start23 Apr 2021
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion31 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05022875
Sponsor's protocol ID
ChangGungUCEOApp
Status last verified
Aug 2021
First submitted
20 Aug 2021
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39805107

Questions about this trial

What is this clinical trial studying?

A study testing Healthcare CEO app- for experimental app intervention in people with Type 1 Diabetes Mellitus, run by Chang Gung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yueh-Tao Chiang, PhD. (+886-3-2118800 ext. 3866, nurs2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Baseline and 3, 6, 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.

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