Efficacy of the "Living With Type 1 Diabetes to Grown-Up" Interactive Podcast Program

Efficacy of the Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-arm Randomized Controlled Trial

The present study aims to evaluate the intervention effectiveness of the Online Interactive Podcast Program"Living with Type 1 Diabetes to Grown-Up"in patients with type 1 diabetes transitioning from adolescence to early adulthood.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: E-book; Device: Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"

Detailed Description

Individuals aged 16-25 with Type 1 Diabetes (T1D) face significant transitional challenges in their lives, with an increased risk of worsening disease management. Addressing these challenges, an interactive podcast program,

"Living with Type 1 Diabetes to Grown-Up"; is being developed with a one-year grant from the National Science and Technology Council. This continued project will span three years, employing a mixed-method research design for evaluation. Participants will be recruited from pediatric endocrinology and genetics clinics and wards across two medical centers in Northern Taiwan. In line with recommendations from prior reviewers, the study will incorporate a two-phased approach: the first phase is a quantitative study, structured around transitional theory and self-regulation theory using PRIDE steps. It adopts a double-blinded, randomized controlled experimental method with data collector and sham treatment participants blinded. Subjects will be randomly assigned to either the experimental group (N=44) or the active control group (N=44). Comparative analyses will focus on variations in disease control, emotional disturbance, confidence in self-management, self-care behaviors, diabetes knowledge, interpersonal disturbance, and family conflict at baseline, and post-interventions of immediate, 3-month, and 6-month periods. In the subsequent qualitative phase, 15-20 cases from the experimental group will be selected for in-depth interviews to evaluate the impact of the " Living with Type 1 Diabetes to GrownUp " interactive podcast program.

The outcomes of this research are anticipated to contribute significantly to the clinical management and technological intervention strategies for T1D adolescents in their transitional phase to adulthood.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueh-Tao Chiang, PhD; Phone Number: +886-3-2118800 Ext. 3866; Email: nurs2004@gmail.com
• Study Contact Backup: Name: Fu-Sung Lo, BSN; Phone Number: +886-3-281200 Ext. 8969; Email: lofusu@kimo.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33302
    • Chang-Gung University and Chang-Gung Memorial Hospital
    • Contact: Yueh-Tao Chiang, PhD.; Phone Number: 3866 +886-3-2118800; Email: nurs2004@gmail.com
    • Contact: Fu-Sung Lo, BSN; Phone Number: 8969 +886-3-281200; Email: lofusu@kimo.com
    • Principal Investigator: Yueh-Tao Chiang, PhD.
    • Sub-Investigator: Hsing-Yi Yu, 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.
    • Sub-Investigator: Wei-Hsin Ting, MS.
    • Sub-Investigator: Wen Yen Lin, PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: podcast intervention; The podcast will be used for intervention in the experimental group.	Device: Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"; The podcast content was designed based on the results of previous research.Subjects will be randomly assigned to either the experimental group (N=44) or the comparison group (N=44). Comparative analyses will focus on variations in disease control, emotional disturbance,confidence in self-management, self-care behaviors, diabetes knowledge,interpersonal disturbance, and family conflict at baseline, and post-interventions of immediate, 3-month, and 6-month periods.
Sham Comparator: Ebook intervention; Participants in the active control group will use E-book.	Device: E-book; Participants in the active control group will use Ebook.According to the research results from the project leader's app effectiveness evaluation (Chiang, 2020-2022), the e-book did not show significant effects on blood sugar control, disease management confidence, self-care behaviors, disease-related knowledge, or interpersonal distress. Therefore, the active control group received a sham treatment in the form of an e-book. The research team extracted content from the CEO APP e-book, with an expert validity of 0.91, and reorganized it into an electronic health education manual titled "Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of HbA1C (%) in participants	HbA1c from baseline, 3month and 6 months	Baseline and 3, 6months
percentage of self-monitored blood glucose readings within the 70-180 mg/dl range in Participants	the percentage of self-monitored blood glucose levels within the optimal range of 70-180 mg/dL	Baseline and 3, 6months
Number of Hyperglycemic Events in Participants	Number of events of each participant with blood sugar >200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed	Baseline and 3, 6months
Number Hypoglycemic Events in Participants	Number of events of each participant with blood sugar <60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed	Baseline and 3, 6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of Diabetes Distress in Participants	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).	Baseline and 3, 6months
Score of Diabetes Self-Managemen in Participants	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, 6months
Score of Diabetes Self-care in Participants	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, 6months
Score of Diabetes Knowledge in Participants	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, 6months
Score of Interpersonal Distress in Participants	Analyze the score changes in the "Diabetes-Related Interpersonal Distress" subscale within the Diabetes Distress Scale (as previously mentioned in the Diabetes Distress Scale score ).	Baseline and 3, 6months
Score of Diabetes-Related Family Conflict in Participants	The Diabetes Family Conflict Scale-Revised (DFCS), revised by Hood et al. (2007), is used to assess family conflict and disagreements related to diabetes care in adolescents with T1D and their parents. The scale consists of 19 items and uses a 3-point scoring system: "Almost Never" scores 1 point, "Sometimes" scores 2 points, and "Almost Always" scores 3 points. Higher scores indicate more conflict. The DFCS has strong psychometric properties, with a Cronbach's α value of .95 for the adolescent version of the scale.	Baseline and 3, 6months

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: self-regulation; transition; type 1 diabetes; podcast
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: T1dPodcastchanggungU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No