Adherence to Activity Limitation Recommendations in Patients With Diabetic Foot Ulcers: a 'Proof of Concept' Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in healthcare professionals' communication style
研究概览
简要总结
This study aims to develop and test a theory-based motivation communication training programme for healthcare professionals working with diabetic foot ulcer patients. The investigators will explore the acceptability of the training programme and examine whether the training leads to changes in healthcare professionals' communication style, and results in greater adherence to treatment recommendations (i.e., reduced weight-bearing) in patients.
详细描述
This is a proof of concept, two-arm non-randomised, controlled before-and-after study. Patient outcomes (perceptions of healthcare professional communication style, treatment self-regulation and adherence to activity reduction) will be collected first during a control/usual care period. Healthcare professionals will then receive the theory-based motivation communication training programme. Subsequently a new group of patients will be recruited as the intervention group and the same outcome measures collected. Control group outcomes will be compared to intervention group outcomes. Interviews will be conducted with healthcare professionals and patients to assess acceptability of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Be aged 18 years and over
- •Have diabetes according to WHO criteria
- •Have a diabetic foot ulcer being treated at the foot clinic at Royal Derby Hospital
- •Be able to communicate and complete questionnaire measures in English
- •Have capacity to consent and agree to participate.
排除标准
- •Patients who are not currently engaging in walking behaviour (e.g., wheelchair-bound patients) or have other physical limitations that restrict ability to use an accelerometer will be excluded.
结局指标
主要结局
Change in healthcare professionals' communication style
时间窗: Baseline
Measured using the 6-item Health Care Climate Questionnaire, and indicated by patients' perceptions of healthcare professional autonomy support being higher in the intervention group compared to the control group.
次要结局
- Change in patients' adherence to activity reduction recommendations(1 month)
- Acceptability of the intervention(Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline)
- Change in patient treatment self-regulation(Baseline)
- Fidelity of delivery(Baseline)