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

Chang Gung University

Status: Not yet enrolling

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"; Device: E-book

Study type: Interventional

Funder types: Other

Identifiers

NCT06464640

T1dPodcastchanggungU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 16 to 25 years old

Volunteers: No Healthy Volunteers

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.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 16 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

podcast intervention

Experimental group

Description:

The podcast will be used for intervention in the experimental group.

Treatment:

Device: Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"

Ebook intervention

Sham Comparator group

Description:

Participants in the active control group will use E-book.

Treatment:

Device: E-book