Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 10
- 主要终点
- feasibility of an intensive nurse led education program
研究概览
简要总结
The purpose of the study is to evaluate the feasibility and effectiveness of a physician directed nurse managed earlier outpatient counselling intervention for patients with diabetic foot ulceration.
For the purpose effectiveness is defined in two ways.1) as a reduction in hospital readmissions for complication for foot ulcers such as amputation or increased severity of the ulcer and 2) reduction in amputations, readmission rates. Selected covariates (self-efficacy,self-management, social support and depression) will be included to estimate predictors for readmission and amputation.
详细描述
Diabetes mellitus (DM) is associates with numerous complications. One of these is decreased peripheral circulation impaired sensation leading to the development of foot ulcers that lead to amputations of toes, feet and limbs. These complications not only have devastating effects on the individual in terms of loss of functionality but also impact the patient's ability to carry out and enjoy occupational, recreational and family functioning activities. Furthermore, foot ulcers and associated problems often lead to prolonged hospitalization and loss of productivity. All of these have personal as well as societal economical implications.
Currently, the standard of care includes admissions to the hospital lasting up to six weeks for medical observations and treatment of food ulcers.
The nursing responsibilities include daily or more frequent wound care as well as education counselling and skill building for diabetes self-management; therefore, an alternative to current practices must be considered. Such an alternative strategy has the potential benefit for the patient as well as the societal benefit of economic savings should such an outpatient nurse managed intervention be as or more effective as current practice. This type of service would allow the patients to remain in their home for care with probably a reduced risk for nosocomial infections.
This pilot randomized clinical trial (RCT) aims to evaluate the feasibility of an additional patient education program to current management of foot care in patients with DM. We plan to determine whether foot ulcer care in hospital under medical and nursing management can be improved by early discharge of the Intervention group (IG) to the well established outpatient wound care combined with an additional new outpatient nurse managed counselling program.
Expected results:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •patients age 18 or older with
- •current treatment for ulceration and/or amputation of a lower limb
- •stable wound healing
- •no signs of wound infection
- •stable diabetes
- •manageable pain
排除标准
- •patients with cognitive impairment and psychiatric diseases
- •patients living in dependent living facilities
结局指标
主要结局
feasibility of an intensive nurse led education program
时间窗: The outcome measures will be assessed after all recruited participants have completed the five week education program - at the latest two years after study start.
Recruitment procedures feasible yes/no; Randomization procedure feasible yes/no; Timeframe of the five week educational program feasible yes/no; Intervention material suitable yes/no
次要结局
未报告次要终点
研究者
Prof. Dr. Lorenz Imhof
Prof. Dr.
Zurich University of Applied Sciences