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临床试验/NCT05174975
NCT05174975已完成不适用

Tri-Service General Hospital, Department of Internal Medicine

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in Self-care behaviour

研究概览

简要总结

The aim of this experimental study is to explore the effectiveness of app-based positive psychology intervention (PPI) on patients newly diagnosed with type 2 diabetes (T2DM).

详细描述

Positive psychological constructs (PPCs), such as optimism, gratitude, self-efficacy, and resilience have been considered to positively impact adherence and self-care behaviour of patients with type 2 diabetes (T2DM). Moreover, diabetes self-care behaviours would be consistently improved as the PPCs have strengthened. Based on systematic reviews, the positive psychological intervention has significantly improved positive emotions, quality of life, self-efficacy, depression, optimism, gratitude, and well-being of patients with T2DM The strengthen of PPCs could be regarded as a strategy for improving type 2 diabetes self-management.

Positive psychology intervention (PPI) emphasis enhancing PPCs via consciousness raising and enhancing personal strengths. With the systemic practice of PPI, it develops individual positive cognition and emotions. A previous Internet-based intervention study found that people have been taught positive emotional skills shown a significantly lower depression level than those having the daily emotional diary. Additionally, a one-group pre-post test study found that both optimism and gratitude have significantly increased after a 12-week phone-based PPI in patients with T2DM. Another one-group pretest-posttest study demonstrated that optimism and well-being had significantly increased after a 12-week PPI. Furthermore, optimism, gratitude, frustrated, depressive, and distress, diabetes self-care and health behaviours adherence have obvious improved. A recent study demonstrated that self-care behaviour and diet behaviour had significantly improved after a 16-week phone-based psychological-motivational interviewing intervention among the patients with Type 2 diabetes (T2DM) with 8 years duration of diabetes. Although previous studies have demonstrated the effectiveness of PPI on PPCs, only few studies investigate the impact on patients newly diagnosed with T2DM. Thus, the aim of this study is to explore the effectiveness of app-based PPI on patients newly diagnosed with T2DM.

Patients newly diagnosed with T2DM of an endocrinology clinic in a medical center in northern Taiwan are assigned to the experimental group (n=57), while patients at an endocrinology clinic in southern Taiwan are assigned to the control group (n=113). Experimental group will have a 3-month App-based intervention, while the control group only have a diabetes-related health education by certificated diabetes educators. Outcome variables will be collected from medical records and self-reported questionnaires. A Generalized Estimation Equation (GEE) is used to compare the changing amount of outcome variables from baseline to week at the end of intervention, to 3 months, and to 9 months post-intervention between a control group and experimental group. A p-value <.05 is considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •newly diagnosed with T2DM less than 6 months
  • •aged 20 to 64
  • •controlling diabetes through oral medication or insulin injection
  • •able to use Android phone

排除标准

  • •unable to communicate with language or having mental illness

研究组 & 干预措施

App-based Positive Psychological Intervention group

Experimental

The intervention will be conducted on the app, including 2-week PPI, diabetes-related health education, physical records, and online consultation.

干预措施: App-based Positive Psychological Intervention (Behavioral)

control group

No Intervention

usual care which will educated by certificated educators in terms of self-management

结局指标

主要结局

Change in Self-care behaviour

时间窗: At baseline and 1 week, 3 months and 9 months after the intervention

A 17-item Diabetes Self-care Behaviour Scale-Chinese version will be used to measure. Each item is rates from 0 (never) to 4 (always). The higher score indicates a greater execution in self-care behaviours.

Change in Quality of life

时间窗: At baseline and 1 week, 3 months and 9 months after the interventiont

A 15-item Quality of Life Scale will be used to measure quality of life. Each item is rated from 0 (Never) to 4(Always), with higher scores indicating a higher quality of life.

Change in Glycosylated hemoglobin(HbA1c) levels

时间窗: At baseline and 1 week, 3 months and 9 months after the intervention

Collect from medical records

次要结局

  • Change in Diabetes Self-efficacy(At baseline and 1 week, 3 months and 9 months after the interventiont)
  • Change in Diabetic Positive Characteristics(At baseline and 1 week, 3 months and 9 months after the intervention)
  • Change in Gratitude(At baseline and 1 week, 3 months and 9 months after the intervention)
  • Change in Diabetes Distress(At baseline and 1 week, 3 months and 9 months after the intervention)
  • Change in Optimism(At baseline and 1 week, 3 months and 9 months after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chieh-Hua Lu

director

Tri-Service General Hospital

研究点 (1)

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