Efficacy of the "Living With Type 1 Diabetes to Grown-Up" Interactive Podcast Program
NCT Number: NCT06464640
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes Mellitus
Interventions: DEVICE: Online Interactive Podcast Program "Living with Type 1 Diabetes to Grown-Up"|DEVICE: E-book
Sponsor: Chang Gung University
Collaborators: Chang Gung Memorial Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 94
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-11-01
Completion Date: 2027-12-31
Locations: Chang-Gung University and Chang-Gung Memorial Hospital, Taoyuan, 33302, Taiwan

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.

Primary Outcome Measures: 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 Outcome Measures: Score of Diabetes Distress in Participants, 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)., Baseline and 3, 6months|Score of Diabetes Self-Managemen in Participants, 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., Baseline and 3, 6months|Score of Diabetes Self-care in Participants, 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., Baseline and 3, 6months|Score of Diabetes Knowledge in Participants, 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), Baseline and 3, 6months|Score of Interpersonal Distress in Participants, 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 )., Baseline and 3, 6months|Score of Diabetes-Related Family Conflict in Participants, 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., Baseline and 3, 6months