Development and Evaluation of Online Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up"

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Development and Evaluation of Online Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Mixed-Methods Study-Continued Research Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464640
• Other study ID #: T1dPodcastchanggungU
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Chang Gung University
• Contact: Yueh-Tao Chiang, PhD
• Phone: +886-3-2118800 Ext. 3866
• Email: nurs2004[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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=47) or the comparison group (N=47). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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=47) or the comparison group (N=47). 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.
• E-book
Participants in the 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 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: Dealing with Type 1 Diabetes."

Locations

Country	Name	City	State
Taiwan	Chang-Gung University and Chang-Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung University	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in % with HbA1c <7.0%	Percentage of individuals in each group with HbA1c <7.0%	Baseline and 3, 6months
Primary	Change in HbA1c	HbA1c from baseline to 6 months	Baseline and 3, 6months
Primary	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, 6months
Primary	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, 6months
Secondary	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 a, and test-retest reliability values of 0.75, 0.93, and 0.97, respectively.	Baseline and 3, 6months
Secondary	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 a and the content validity index (CVI) value based on content rating by experts are 0.87 and 0.92, respectively.	Baseline and 3, 6months
Secondary	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 a and test-retest reliability values of the DDS were 0.89 and 0.81, respectively Liu et al.(2010).	Baseline and 3, 6months
Secondary	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 a 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, 6months
Secondary	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 a values of 0.78 and 0.89, respectively Hu et al.(2013)	Baseline and 3, 6months