NCT02594748暂停不适用
The Effects of Self-management Education Based on Theory of Planned Behavior on Self-management and Quality of Life of Patients With Type 2 Diabetes and the Other Influencing Factors of Quality of Life
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
研究概览
简要总结
The aims of the study are as follows:
- To improve self-management intention and behavior of patients with type 2 diabetes (T2 DM).
- To promote patients to make plans for their self-management and gradually integrate the self-management plan into their daily life.
- To improve resilience, well-being, fatigue and quality of life of patients with T2 DM
In order to achieve the aims, we have set the following objectives:
- To develop and apply self-management education program based on the extended theory of planned behavior.
- To evaluate the efficacy of the educational program:
- Self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).
详细描述
This study employs a quasi-experimental study design with an intervention and comparison group and follow-up of 3 months; there will be two measuring points (baseline and 3 months after the intervention) , and 9 measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years
- •duration of type 2 diabetes ≥3 months
- •without any severe complication and impaired cognition.
- •Exclusion criteria are:
- •severe physical handicap or mental illness
- •presence of other serious disease such as cancer and stroke.
排除标准
- 未提供
结局指标
主要结局
Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
时间窗: baseline and at three months.
Measure the impact and important of 19 life domains.
次要结局
- Change from baseline in Fatigue-14 scale at 3-month follow up.(Baseline,3-month follow up.)
- Change from baseline in Well-Being Index (WHO-5)(Baseline,3-month follow up.)
- Change from baseline in The Summary of Diabetes Self-Care Activities Measure at 3-month follow up.(Baseline,3-month follow up.)
- Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.(Baseline,3-month follow up.)
- Change from baseline in HbA1c at 3-month follow up.(Baseline, 3-month follow up.)
- Change from baseline in BMI at 3-month follow up.(Baseline,3-month follow up.)
- Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.(Baseline,3-month follow up.)
- Change from baseline in Blood sugar at 3-month follow up.(Baseline,3-month follow up.)
研究者
FangFang Zhao
PhD student
University of Turku
研究点 (1)
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