Tri-Service General Hospital, Department of Internal Medicine
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
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
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
Chieh-Hua Lu
director
Tri-Service General Hospital
