Effects of Empowerment-based Program on Post-discharge Self-care Behavior, Glycemic Control, and Prevention of Foot Ulcer Infection and Occurrence in Patients With Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Foot infection and recurrence of foot ulcer
研究概览
简要总结
The purpose of this study is to evaluate an empowerment-based program. A randomized controlled trial design will be used. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.
详细描述
A randomized controlled trial design will be used to evaluate an empowerment-based program.. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years old.
- •Could communicate with Mandarin or Taiwanese.
- •The glycated hemoglobin value is higher or equal to 7.5%.
- •The vibration or monofilament test results are abnormal.
- •Wagner stage 1 or 2 foot ulcer
- •The location of ulcer is at the big toes or on the sole
排除标准
- •Cognitive impairment
- •Severe lower extremity arterial insufficiency disease
- •Osteomyelitis or foot ulcer recurrent
- •Alcoholism or Drug addiction
- •Autoimmune disease
- •Unable to perform daily self-care activity
- •The main caregivers are foreigner and no other family members live together
- •The C-reactive protein values are higher than 15 mg/dL
- •Admitting in a long-term care institution after discharge from hospital
- •No intention of the return-visit at the clinic of research hospital
研究组 & 干预措施
Experimental group
Participants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation).
干预措施: individual empowerment-based intervention (Behavioral)
Control group
Participants will receive routine care of the research setting only. The counseling will be provided if participants request.
结局指标
主要结局
Foot infection and recurrence of foot ulcer
时间窗: 5 minutes
Foot assessment and the review of medical record
Glycemic control
时间窗: Less than 1 minute
Glycated hemoglobin value
次要结局
- Self-efficacy regarding diabetes foot self-car(1 minutes)
- Self-care behaviors of foot care(3 minutes)
- Diabetes Management Self-Efficacy(10 minutes)
- Self-care behaviors of diabetes(4 minutes)
- Self-efficacy regarding diabetes-related foot ulcer self-management(5 minutes)
- Knowledge regarding warning signs of diabetic foot ulcer(5 minutes)
- Diabetes-related Foot Ulcer Self-Management Behavior(9 minutes)
研究者
Chin yenfan
assistant professor
Chang Gung Memorial Hospital