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
1 other identifier
interventional
88
1 country
1
Brief 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.
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 Nov 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2024
CompletedFirst Posted
Study publicly available on registry
June 18, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
October 15, 2024
October 1, 2024
3.2 years
June 13, 2024
October 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
Score of Diabetes Distress in Participants
Baseline and 3, 6months
Score of Diabetes Self-Managemen in Participants
Baseline and 3, 6months
Score of Diabetes Self-care in Participants
Baseline and 3, 6months
Score of Diabetes Knowledge in Participants
Baseline and 3, 6months
Score of Interpersonal Distress in Participants
Baseline and 3, 6months
- +1 more secondary outcomes
Study Arms (2)
podcast intervention
EXPERIMENTALThe podcast will be used for intervention in the experimental group.
Ebook intervention
SHAM COMPARATORParticipants in the active control group will use E-book.
Interventions
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.
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.\"
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, Lo FS, Yu HY, Chen CW, Moons P. Efficacy of the Online Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-Arm Randomized Controlled Trial Protocol. J Diabetes Res. 2025 Sep 13;2025:4866975. doi: 10.1155/jdr/4866975. eCollection 2025.
PMID: 40978315DERIVED
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, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 13, 2024
First Posted
June 18, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
October 15, 2024
Record last verified: 2024-10