Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient satisfaction (change from baseline)
研究概览
简要总结
The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.
详细描述
Diabetic foot ulcers (DFUs) frequently lead to major amputation and mortality. While relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. Participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. This occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and DFU care team members.
Participants with DFUs will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. Participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. Investigators will also offer focus group interviews to the DFU care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Age 21 years or older
- •History of active DFU necessitating offloading
- •Capacity to provide informed consent
- •Access to telehealth (internet connection and equipment)
- •Ability to walk independently or with an assistive device
- •Self-reported life expectancy of more than one year
排除标准
- •Self-reported deafness or blindness
- •history of lower extremity amputation besides toes
结局指标
主要结局
Patient satisfaction (change from baseline)
时间窗: Baseline and discharge from OT (3 to 8 weeks)
Participants will fill out a general satisfaction survey, adapted from and comprising 18 items from a validated measure: Short-Form Patient Satisfaction Questionnaire (PSQ-18). The scale ranges from 1 (strongly agree) to 5 (strongly disagree).
次要结局
- Diabetes distress (change from baseline)(Baseline and discharge from OT (3 to 8 weeks))
- Offloading knowledge and attitudes (change from baseline)(Baseline and discharge from OT (3 to 8 weeks))
- Frequency of DFU-related outcomes(6-month post-enrollment)
研究者
Tze-Woei Tan
Associate Professor of Clinical Surgery
University of Southern California