INSTITUTIONAL CARE, Pressure Ulcer (PU), Pressure Ulcers, Bedsores, Decubitus Ulcer, Quality of Life, Wound Care, Wound Closure
Conditions
Keywords
Pressure Ulcer, Quality of life, Home-Based, Institutional Care, wound care, wound closure, wound treatment
Brief summary
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.
Detailed description
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. Nurses will provide services according to an individualized care plan developed based on an assessment of the patient's health status, level of independence, and home conditions. Care will include, among other things, measuring vital signs, changing dressings, treating chronic wounds, administering medications (including injections), inserting catheters, and preventing pressure ulcers and complications resulting from limited mobility. Particular emphasis will be placed on health education for both patients and their caregivers - regarding self-care, self-care, and safe and effective functioning at home. The nurse will also serve as a coordinator, monitoring the patient's condition and, if necessary, informing the physician or other medical services about the need for additional interventions. The goal of home care is to improve the patient's quality of life, maintaining their health and functioning in the familiar and safe environment of home. Scope of care and nursing procedures in long-term care facilities: Patients residing in long-term care facilities will receive 24-hour nursing care provided by qualified personnel. This care will be implemented in accordance with an individualized care plan developed based on the patient's current health and functional needs. Daily nursing care, general condition monitoring, symptom monitoring, and support with basic activities of daily living such as hygiene, nutrition, and mobility will be provided. Nurses will also monitor medication intake and manage and supervise the prevention of complications related to immobilization (including pressure ulcers). Nursing care will also include health education for patients and, where possible, their families and caregivers. This care aims to maintain independence, improve quality of life, and support active participation in the treatment process. Pressure ulcer prevention and treatment methods: Proceedings will be in accordance with medical recommendations and best clinical practices. This will include: pressure ulcer risk assessment, body positioning, skin care, appropriate dressings, pain and infection management, and nutritional and rehabilitation support.
Interventions
BEHAVIORALresidential home care treatment
residential home care treatment
BEHAVIORALlong-term care treatment
long-term care treatment
Sponsors
The Jerzy Kukuczka Academy of Physical Education in Katowice
Salus Care Center, Rybnik, Poland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire Assessment - EQ-5D-5L Scale | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSNS Scale | From enrollment, during the study at 6 week and to the end of the study at 12 weeks | Newcastle Satisfaction with Nursing Scale (NSNS) - a validated instrument used to evaluate patients' experiences of and satisfaction with the quality of nursing care received during hospitalization or other healthcare services. NSNS is used in clinical studies on the quality of nursing care in various medical facilities. It allows for the assessment of patient satisfaction with nursing care and fits perfectly with the study's objective, which concerns pressure ulcer management, where daily care, dressing changes, pressure ulcer prevention, and interpersonal relationships with staff are key. It can be used in both home care and inpatient settings. The questionnaire uses clear and straightforward language, making it suitable for older adults. Transformed scores on both subscales range from a minimum of 0 to a maximum of 100, where higher scores mean a better outcome. Assessment will be conducted before the start of the study and then after 6 and 12 weeks of the study (end of the study). |
| Costs of pressure ulcer prevention and treatment assessment | From enrollment to the end of treatment at 12 weeks | In long-term care, the following costs will be taken into account primarily: 1. Personnel costs (nursing, care, and rehabilitation services). 2. Basic medical supplies and standard dressings (e.g., gauze, bandages, sterile compresses). 3. Medications from the reimbursement list. 4. Patient meals and accommodations. In home care (long-term nursing home care), the following costs will be taken into account primarily: 1. Community nurse visits (nursing services costs). 2. Basic dressings and medical supplies costs. 3. Nursing procedures (dressing changes, measurements, patient and family education). In both types of care, the following will also be taken into account: * Costs of specialized dressings and care products. * Transport costs for a home care nurse * Rental costs of pressure-relief equipment (e.g., alternating pressure mattresses). * Working time of non-medical caregivers. * Additional diagnostics and specialist consultations. The costs will be added up and calculated. |
Countries
Poland
Contacts
CONTACTAnna Polak, Prof.
CONTACTLaura Piejko, PT, PhD
PRINCIPAL_INVESTIGATORAnna Polak, Prof.
The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
Outcome results
None listed