Efficacy of the Interactive Podcast Program "Living With Type 1 Diabetes to Grown-Up": A Two-arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Number of Hyperglycemic Events in Participants
研究概览
简要总结
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.
详细描述
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=47) or the comparison group (N=47). 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 25 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •# T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
结局指标
主要结局
Number of Hyperglycemic Events in Participants
时间窗: Baseline and 3, 6months
Number of events of each participant with blood sugar \>200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed
Concentration of HbA1C (%) in participants
时间窗: Baseline and 3, 6months
HbA1c from baseline, 3month and 6 months
Number Hypoglycemic Events in Participants
时间窗: Baseline and 3, 6months
Number of events of each participant with blood sugar \<60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed
percentage of self-monitored blood glucose readings within the 70-180 mg/dl range in Participants
时间窗: Baseline and 3, 6months
the percentage of self-monitored blood glucose levels within the optimal range of 70-180 mg/dL
次要结局
- Score of Diabetes Knowledge in Participants(Baseline and 3, 6months)
- Score of Diabetes-Related Family Conflict in Participants(Baseline and 3, 6months)
- Score of Diabetes Distress in Participants(Baseline and 3, 6months)
- Score of Diabetes Self-Managemen in Participants(Baseline and 3, 6months)
- Score of Diabetes Self-care in Participants(Baseline and 3, 6months)
- Score of Interpersonal Distress in Participants(Baseline and 3, 6months)
研究者
Yueh-Tao Chiang
Assistant Professor
Chang Gung University
