Clinical trial NCT06464640: Efficacy of the "Living With Type 1 Diabetes to Grown-Up" Interactive Podcast Program
Official title: Efficacy of the Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes
transition
podcast
self-regulation
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2024-06-18
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: The Online Interactive Podcast Program\&amp;#34;Living with Type 1 Diabetes to Grown-Up\&amp;#34; will be used for intervention in the experimental group.

active control group:E-book.According to the research results from the project Healthcare CEO 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\&amp;#34;Transitioning from Adolescence to Early Adulthood: The Ins and Outs of Type 1 Diabetes.\&amp;#34;
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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,

\&amp;#34;Living with Type 1 Diabetes to Grown-Up\&amp;#34;; 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 \&amp;#34; Living with Type 1 Diabetes to GrownUp \&amp;#34; 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of HbA1C (%) in participants
timeFrame: Baseline and 3, 6months
measure: percentage of self-monitored blood glucose readings within the 70-180 mg/dl range in Participants
timeFrame: Baseline and 3, 6months
measure: Number of Hyperglycemic Events in Participants
timeFrame: Baseline and 3, 6months
measure: Number Hypoglycemic Events in Participants
timeFrame: Baseline and 3, 6months
Secondary outcomes:
measure: Score of Diabetes Distress in Participants
timeFrame: Baseline and 3, 6months
measure: Score of Diabetes Self-Managemen in Participants
timeFrame: Baseline and 3, 6months
measure: Score of Diabetes Self-care in Participants
timeFrame: Baseline and 3, 6months
measure: Score of Diabetes Knowledge in Participants
timeFrame: Baseline and 3, 6months
measure: Score of Interpersonal Distress in Participants
timeFrame: Baseline and 3, 6months
measure: Score of Diabetes-Related Family Conflict in Participants
timeFrame: Baseline and 3, 6months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang-Gung University and Chang-Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Yueh-Tao Chiang, PhD
role: STUDY_DIRECTOR
affiliation: Chang Gung Memorial Hospital
name: Fu-Sung Lo, BSN
role: STUDY_DIRECTOR
References: