Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06464640

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang-Gung University and Chang-Gung Memorial Hospital

Taoyuan, 33302, Taiwan

Location contact

Chi-Wen Chang, PhD.

SUB_INVESTIGATOR

Chi-wen Chen, PhD.

SUB_INVESTIGATOR

Chienlung Hsu, PhD.

SUB_INVESTIGATOR

Fu-Sung Lo, BSN

CONTACT

[email protected]

+886-3-281200 ext. 8969

Fu-Sung Lo, BSN

PRINCIPAL_INVESTIGATOR

Hsing-Yi Yu, PhD.

SUB_INVESTIGATOR

Pei-kwei Tsay, PhD.

SUB_INVESTIGATOR

Philip Moons, PhD.

SUB_INVESTIGATOR

Wei-Hsin Ting, MS.

SUB_INVESTIGATOR

Wen Yen Lin, PhD.

SUB_INVESTIGATOR

Yueh-Tao Chiang, PhD.

CONTACT

[email protected]

+886-3-2118800 ext. 3866

Yueh-Tao Chiang, PhD.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

E-book

Device

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."

Primary outcomes

  1. Concentration of HbA1C (%) in participants

    Time frame: Baseline and 3, 6months

    HbA1c from baseline, 3month and 6 months

  2. percentage of self-monitored blood glucose readings within the 70-180 mg/dl range in Participants

    Time frame: Baseline and 3, 6months

    the percentage of self-monitored blood glucose levels within the optimal range of 70-180 mg/dL

  3. Number of Hyperglycemic Events in Participants

    Time frame: Baseline and 3, 6months

    Number of events of each participant with blood sugar >200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed

  4. Number Hypoglycemic Events in Participants

    Time frame: Baseline and 3, 6months

    Number of events of each participant with blood sugar <60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed

Secondary outcomes

  1. Score of Diabetes Distress in Participants

    Time frame: Baseline and 3, 6months

    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).

  2. Score of Diabetes Self-Managemen in Participants

    Time frame: Baseline and 3, 6months

    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.

  3. Score of Diabetes Self-care in Participants

    Time frame: Baseline and 3, 6months

    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.

  4. Score of Diabetes Knowledge in Participants

    Time frame: Baseline and 3, 6months

    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)

  5. Score of Interpersonal Distress in Participants

    Time frame: Baseline and 3, 6months

    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 ).

  6. Score of Diabetes-Related Family Conflict in Participants

    Time frame: Baseline and 3, 6months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fu-Sung Lo, BSN

CONTACT

[email protected]

+886-3-281200 Ext. 8969

Yueh-Tao Chiang, PhD

CONTACT

[email protected]

+886-3-2118800 Ext. 3866

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.