Comparative Assessment of the Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Quality of Life Questionnaire Assessment - EQ-5D-5L Scale
研究概览
简要总结
A study aimed at comparing the effectiveness of treatment, costs, and quality of life of patients with pressure ulcers in home care and institutional care.
Eighty individuals aged 60-90 years with stage II-IV pressure ulcers can participate in the study.
Participants will be assessed for factors such as health status, independence, mood, and quality of life.
The study will allow for better tailoring care to patients' needs. Other benefits of participating in the study is that the participants will receive a detailed assessment of their health, nutrition, quality of life, as well as support in managing their pressure ulcers. They will receive regular care and medical evaluations, which may positively impact their health and well-being.
Refusing to participate in this study will not affect the patients treatment in any way.
Please ask if there is anything that is unclear or if you would like additional information.
Taking part in this study is entirely voluntary.
详细描述
The aim of the study is to evaluate and compare the effectiveness and costs of pressure ulcer treatment and the quality of life of patients with pressure ulcers receiving home and institutional care.
The study will include 80 patients with stage II-IV pressure ulcers, including:
- 40 patients residing in long-term care facilities (nursing and treatment facilities);
- 40 patients residing in their homes and receiving outpatient care.
Scope of care and nursing procedures for home care:
As part of home care, patients will receive regular nursing visits conducted on average four times a week, with the frequency adjustable - including on weekends and holidays - depending on the patient's health status and individual needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men aged 60 to 90 years,
- •stage II-IV pressure ulcers in the lumbar-sacral area of the trunk, pelvic girdle, and lower limbs,
- •high risk of pressure ulcers (above 15 points on the Waterlow scale),
- •daily functional ability below 40 points on the Barthel scale,
- •consent from the patient or legal guardian/caregiver to participate in the study.
排除标准
- •General contraindications (acute inflammatory conditions and febrile illnesses, venous thrombosis, cachexia),
- •pressure ulcers requiring surgical treatment (black necrosis, inflammation of bones and soft tissues),
- •tunneling pressure ulcers showing signs of acute inflammation,
- •pressure ulcers showing signs of infection (causing fever, swelling, pain, and unpleasant odor),
- •pressure ulcers with a surface area of less than 0.5 cm2,
- •pressure ulcers occurring on the lower legs or feet in patients with acute and chronic venous insufficiency and diabetes,
- •multiple pressure ulcers (>2),
- •malignant tumors,
- •decompensated diabetes,
- •end-stage chronic heart failure,
- •end-stage renal disease,
- •mental illness.
研究组 & 干预措施
GE-2
Experimental Group 2 (GE2), in which 40 patients will be treated in residential home care facilities The study will be conducted for 12 weeks.
The following will be assessed:
- Effectiveness of pressure ulcer treatment based on changes in pressure ulcer surface area.
- Patient quality of life and satisfaction with nursing care.
- Costs of pressure ulcer prevention and treatment.
干预措施: residential home care treatment (Behavioral)
GE-1
Experimental group 1 (GE1), in which 40 patients will be treated in long-term care facilities
The study will be conducted for 12 weeks. The following will be assessed:
- Effectiveness of pressure ulcer treatment based on changes in pressure ulcer surface area.
- Patient quality of life and satisfaction with nursing care.
- Costs of pressure ulcer prevention and treatment.
干预措施: long-term care treatment (Behavioral)
结局指标
主要结局
Quality of Life Questionnaire Assessment - EQ-5D-5L Scale
时间窗: From enrollment, during the study at 6 week and at the end of the study at 12 weeks
Quality of Life Questionnaire assessment will be conducted using the EQ-5D-5L - a standardized generic instrument for measuring health-related quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, together with a self-rated health visual analogue scale (EQ VAS) or QOL-AD (Quality of Life in Alzheimer's Disease) - a validated questionnaire designed to assess quality of life in individuals with dementia. The questionnaire will be presented in a version for the patient and a caregiver. The index scores range from roughly -0.59 to 1 (higher = better outcome), and EQ VAS scores range from 0 to 100 (higher = better health) Assessment will be conducted before the start of the study and then after 6 and 12 weeks of the study (the end of the study).
Planimetry
时间窗: Form enrolment for every two weeks to the end of the study at 12 weeks
Planimetry - a quantitative method used to measure the surface area of pressure ulcers (cm²) to monitor wound healing over time. Measurements will be performed every two weeks. If the pressure ulcer heals before the end of the 12th week, the date of healing will be recorded in the documentation. The surface area of the pressure ulcer will be measured using planimetry. First, a waterproof marker will be used to trace the contours of the pressure ulcer on a transparent, soft, non-stretchable film, which will be placed directly on the pressure ulcer after disinfection. Next, the contour of the pressure ulcer will be transferred to a transparent, rigid film, and the surface area of the defect will be measured using a planimeter (Mutoh Kurta XGT, Altek, USA). The planimeter will be connected to a computer equipped with special C-GEO software (version 4.0, Nadowski SoftLine, PL), which allows for the calculation of pressure ulcer surface area and data storage.
次要结局
- NSNS Scale(From enrollment, during the study at 6 week and to the end of the study at 12 weeks)
- Costs of pressure ulcer prevention and treatment assessment(From enrollment to the end of treatment at 12 weeks)
研究者
Laura Piejko
PT, PhD
The Jerzy Kukuczka Academy of Physical Education in Katowice