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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-25
SponsorChang Gung University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.\"

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: podcast interventionExperimental treatment 1 intervention
Group B: Ebook interventionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Concentration of HbA1C (%) in participants

HbA1c from baseline, 3month and 6 months

Time frame
Baseline and 3, 6months
2

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

Time frame
Baseline and 3, 6months
3

Number of Hyperglycemic Events in Participants

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

Time frame
Baseline and 3, 6months
4

Number Hypoglycemic Events in Participants

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

Time frame
Baseline and 3, 6months

Secondary outcomes

1

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).

Time frame
Baseline and 3, 6months
2

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.

Time frame
Baseline and 3, 6months
3

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.

Time frame
Baseline and 3, 6months
4

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)

Time frame
Baseline and 3, 6months

Other outcomes

Sponsors and contacts

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Chang Gung University

Lead sponsor

Chang Gung Memorial Hospital

Collaborator

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