Evaluation of the Diabetes and WELLbeing (DWELL) Programme for People With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 594
- 试验地点
- 10
- 主要终点
- Change in diabetes self-management as assessed by the Diabetes Self-Care Activities Measure
研究概览
简要总结
This study evaluates the impact of 'DWELL' - a 12-week psycho-social education programme designed to help people with type 2 diabetes to better self-manage their condition. Up to 600 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes
详细描述
The DWELL (Diabetes and WELLbeing) 12-week programme has been designed to incorporate specific elements of diabetes education and is underpinned by motivational interviewing to ensure it is tailored to individuals. Each of the four elements of the programme - education, nutrition, physical activity and wellbeing - have been carefully selected based on previous research into diabetes education. The Canterbury Christ Church University (CCCU) DWELL Team are responsible for the evaluation of DWELL, which will explore whether the combination of the programme elements is effective in improving self-management. Additionally, a process evaluation and cost effectiveness analysis will be conducted alongside participant outcomes
The programme will be delivered at five sites (two in the UK, one in Belgium, one in France, one in the Netherlands). The CCCU DWELL research team will be responsible for quality assurance, management and analysis of data, sample size assessment and reporting of adverse events. Each delivery site is responsible for adhering to their own Standard Operating Procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Clinical diagnosis of type 2 diabetes
- •Over the age of 18
排除标准
- •Under the age of 18
- •Pregnant women
- •Individuals who do not have the mental capacity to participate
结局指标
主要结局
Change in diabetes self-management as assessed by the Diabetes Self-Care Activities Measure
时间窗: Baseline, end of programme (3 months), 6 months after programme, 12 months after programme
Changes in self-management and self-care will be measured using the Diabetes Self-Care Activities Measure at four time points. The SDSCA assesses aspects of the diabetes regimen. Higher scores indicate greater taking of prescribed medication and undertaking footcare regime.
次要结局
- Change in levels of physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Change in waist circumference(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Change in eating behaviour as assessed by the Dutch Eating Behaviour Questionnaire (DEBQ)(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Change in quality of life as assessed by the Short Form Health Survey (SF-12)(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Change in illness perception as assessed by the Illness Perception Questionnaire (IPQ-R)(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Change in Body Mass Index (BMI) as assessed by height and weight(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Change in psychosocial self-efficacy as assessed by the Diabetes Empowerment Scale (DES-SF)(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Quality Adjusted Life Years (QALYs)(2.5 years)
- Change in average blood glucose levels as assessed by Hemoglobin A1c levels (HbA1c)(Baseline, end of programme (3 months), 6 months after programme, 12 months after programme)
- Cost effectiveness(2.5 years)