Type 2 Diabetes: Risk Perceptions and Self-management Behaviour
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators
研究概览
简要总结
This pilot randomised controlled trial (RCT) aims to assess the feasibility of using a new type of risk communication intervention for people with Type 2 diabetes mellitus (T2DM) in primary care and to evaluate its potential impact on risk perceptions and self-management behaviour.
The study comprises 40 participants with T2DM randomly allocated to usual care supported by the risk communication intervention or usual care only.
详细描述
Diabetes self-management, which includes self-care behaviours such as healthy eating and physical exercise, has become the cornerstone for treating type-2 diabetes mellitus (T2DM). However, although self-management education (SME) is necessary to equip patients with the knowledge, skills and attitudes required to manage their diabetes care, the most effective method to do so is still unclear.
Recent studies have shown that people with T2DM underestimated their risks of developing complications. Although behavioural processes are complex, wrong risk perceptions are a major impediment to the adoption of self-care behaviours and, as a result, an additional risk for the occurrence of adverse outcomes.
Existing risk communication interventions have shown mixed results, with many participants barely understanding the explanations of health professionals about risks and having poor recall of risk information. In this context, there is a need for better risk communication interventions.
Based on the results of recent studies investigating the risk perceptions and risk attitudes of people with T2DM, we have developed a new, tailored risk communication intervention. The objectives of this intervention are:
- To increase the awareness of risks for complications associated with type 2 diabetes.
- To encourage the adoption of recommended self-care behaviours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Diagnosed with type-2 diabetes.
排除标准
- •Unable to provide informed consent.
- •Non-English speaker.
- •Not suitable for the study according to GP.
研究组 & 干预措施
Intervention and usual care
Risk communication intervention and usual care including personalized lifestyle advice
干预措施: Personalized Risk Communication for People with Type 2 Diabetes (Other)
Usual care only
Usual care including personalized lifestyle advice
结局指标
主要结局
Feasibility of implementing the intervention in primary care: Binary outcome (feasible / not feasible), as judged by the investigators
时间窗: 3 months
Binary outcome (feasible / not feasible), as judged by the investigators following analysis of study pre-specified outcome measures.
次要结局
- Recall of personalised risk information(3 months)
- Intentions to make lifestyle changes(3 months)
- Change in self-management behaviour(3 months)