Assessment of a Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 172
- 主要终点
- The Patient Activation Measure (PAM)
研究概览
简要总结
The overall aim of this study is to assess the effectiveness of a web-based Guided Self-Determination program among adults with type 2 diabetes in general practice in order to improve diabetes self-management behaviours and HbA1c through enhanced patient activation, self-care competence, and autonomy.
详细描述
Web-based self-management programs have the potential to support adults with type 2 diabetes in managing their disease condition. However, improving health care outcomes through self-management interventions have shown somewhat ambiguous results. Therefore, it is suggested that interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. To meet these challenges, the overall aim of this study is to assess the effectiveness of a theory-driven web-based Guided Self-Determination intervention among adults with type 2 diabetes in general practice in order to enable adults with diabetes to use their individual resources to self-manage their condition and reach treatment goals.
A complex intervention design based on the framework of UK Medical Research Council is employed as a guide for developing and evaluating the intervention.
This study consists of three phases:
- the modelling phase adapting the original Guided Self-Determination program to adults with type 2 diabetes, using a qualitative design
- feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and
- evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design.
The two first phases will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effect on health care outcomes of this systematically developed intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes of duration ≥ 3 months
- •Ability to communicate in Norwegian
- •Access to the internet and bank ID
排除标准
- •Patients with cognitive impairment
- •Patients with severe co-morbidity
结局指标
主要结局
The Patient Activation Measure (PAM)
时间窗: Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months
次要结局
- Summary of diabetes self-care activities (SDSCA)(Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months)
- The Health Care Climate Questionnaire (HCCQ)(Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months)
- Treatment Self-Regulation (TSRQ)(At three time points: at baseline, 12-16 weeks later at the end of the intervention and six months after finishing the intervention.)
- Diabetes Management Self-efficacy Scale (SE-type 2 diabetes)(Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months)
- The WHO 5-item Well-Being Index (WHO-5)(Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months)
- Diabetes Distress Scale (DDS)(Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12- 16 weeks at 6 months)
- Glycosylated haemoglobin (HbA1c)(Assessing change between three time points: Change from baseline at 12-16 weeks, and change from 12-16 weeks at 6 months)
- Perceived Competence for Diabetes Scale (PCDS)(Assessing change between three time points: Change from baseline at 12- 16 weeks, and change from 12- 16 weeks at 6 months)