Effectiveness of The Health Care CEO App for T1D

August 21, 2021 updated by: Yueh-Tao Chiang, Chang Gung University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fu-Sung Lo, BSN
  • Phone Number: 8969 +886-3-281200
  • Email: lofusu@kimo.com

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 33302
        • Recruiting
        • Chang-Gung University and Chang-Gung Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yueh-Tao Chiang, PhD.
        • Sub-Investigator:
          • Hsing-Yi Yu, PhD.
        • Sub-Investigator:
          • Chi An, PhD.
        • Sub-Investigator:
          • Chi-wen Chen, PhD.
        • Sub-Investigator:
          • Chi-Wen Chang, PhD.
        • Sub-Investigator:
          • Chienlung Hsu, PhD.
        • Principal Investigator:
          • Fu-Sung Lo, BSN
        • Sub-Investigator:
          • Philip Moons, PhD.
        • Sub-Investigator:
          • Pei-kwei Tsay, PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental app intervention
The complete Healthcare CEO app will be used for intervention in the experimental group.
Device: 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
Sham Comparator: Control app intervention
Participants in the control group will only install the "CEO's Profile" and "Health Tracking" interfaces of the Healthcare CEO app.
Device: Healthcare CEO app-for control app intervention
consists of 2 interfaces: CEO's profile, Health Tracking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Baseline and 3, 6, 9 months
HbA1c from baseline to 9months
Baseline and 3, 6, 9 months
Change in % with HbA1c <7.0%
Time Frame: Baseline and 3, 6, 9 months
Percentage of individuals in each group with HbA1c <7.0%
Baseline and 3, 6, 9 months
Change in Hyperglycemic Events
Time Frame: Baseline and 3, 6, 9 months
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
Time Frame: Baseline and 3, 6, 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived Diabetes Self-Management Scale score over time
Time Frame: Baseline and 3, 6, 9 months
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.
Baseline and 3, 6, 9 months
Change in Self-care Behavior Assessment Scale score over time
Time Frame: Baseline and 3, 6, 9 months
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.
Baseline and 3, 6, 9 months
Change in Diabetes Distress Scale score over time
Time Frame: Baseline and 3, 6, 9 months
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).
Baseline and 3, 6, 9 months
Change in Diabetes Quality of Life Scale score over time
Time Frame: Baseline and 3, 6, 9 months
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.
Baseline and 3, 6, 9 months
Change in Diabetes Knowledge Questionnaire score over time
Time Frame: Baseline and 3, 6, 9 months
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)
Baseline and 3, 6, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Collaborators

Chang Gung Memorial Hospital

Investigators

  • Study Director: Yueh-Tao Chiang, PhD, Chang Gung University
  • Study Director: Fu-Sung Lo, BSN, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 21, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 21, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChangGungUCEOApp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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