Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care

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

Registry ID
NCT07763106
Source registry
NCT
Status
NOT_YET_RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
The Jerzy Kukuczka Academy of Physical Education in Katowice
Enrollment
80
Start date
2026-09-01
Completion date
2027-12-31
Last update
2026-08-13

Conditions

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

Inclusion criteria

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

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.

Primary outcomes

[{"measure":"Quality of Life Questionnaire Assessment - EQ-5D-5L Scale","timeFrame":"From enrollment, during the study at 6 week and at the end of the study at 12 weeks"},{"measure":"Planimetry","timeFrame":"Form enrolment for every two weeks to the end of the study at 12 weeks"}]

Locations

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