Effectiveness of the 'Healthcare CEO' App for Type 1 Diabetes Patients Transitioning From Adolescence to Early Adulthood: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in Hypoglycemic Events
研究概览
简要总结
The present study aims to evaluate the intervention effectiveness of the Healthcare Chief Executive Officer mobile application(Healthcare CEO app) in patients with type 1 diabetes transitioning from adolescence to early adulthood.
详细描述
Aim:The present study aims to evaluate the intervention effectiveness of the Healthcare Chief Executive Officer mobile application in patients with type 1 diabetes transitioning from adolescence to early adulthood.
Design: A 9-month two-arm, parallel-group, single-blind, randomized controlled trial Methods: Ninety-six Type-1 diabetes patients, aged 16-25 years, are expected to participate in this study. Participants will be randomly assigned to the experimental or control group by central randomization. The Healthcare Chief Executive Officer app, which consists of the following functions: data recording, knowledge, communication skills, food swap guide, exercise recommendations, chatroom, reminders, and SOS, will be used as the intervention measure. We will compare the differences in disease control outcomes, confidence in self-management, self-care behaviors, emotional distress, quality of life, and specific diabetes-related knowledge between the two groups before intervention and at 3, 6, and, 9 months post-intervention. The differences within the experimental group pre- and post- intervention will also be analyzed. This study design was approved by the ethics committee of the researcher's affiliation in March 2021.
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, Care Provider)
盲法说明
Blinding strategies include the following: (1) the statistician will not be allowed to disclose the randomization results to others; (2) after physician referral, the participant will be immediately ushered to a separate room to ensure that the caregiver does not receive information regarding the intervention content; and (3) participants of both the experimental and control groups will download the app, but app content will be different between the two groups. (4) research assistants will specially emphasize for all participants that app usage is beneficial for disease management.
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
Change in Hypoglycemic Events
时间窗: Baseline and 3, 6, 9 months
Number of events of each participant with blood sugar \<60 mg/dl or "low" on glucometer, Hypoglycemia diagnosed
Change in HbA1c
时间窗: Baseline and 3, 6, 9 months
HbA1c from baseline to 9months
Change in % with HbA1c <7.0%
时间窗: Baseline and 3, 6, 9 months
Percentage of individuals in each group with HbA1c \<7.0%
Change in Hyperglycemic Events
时间窗: Baseline and 3, 6, 9 months
Number of events of each participant with blood sugar \>200 mg/dl or" high" on glucometer, Ketoacidosis diagnosed
次要结局
- Change in Perceived Diabetes Self-Management Scale score over time(Baseline and 3, 6, 9 months)
- Change in Diabetes Quality of Life Scale score over time(Baseline and 3, 6, 9 months)
- Change in Self-care Behavior Assessment Scale score over time(Baseline and 3, 6, 9 months)
- Change in Diabetes Distress Scale score over time(Baseline and 3, 6, 9 months)
- Change in Diabetes Knowledge Questionnaire score over time(Baseline and 3, 6, 9 months)
研究者
Yueh-Tao Chiang
Assistant Professor
Chang Gung University