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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Polak, Prof.
- Phone Number: + 48 0322075301
- Email: a.polak@awf.katowice.pl
Study Contact Backup
- Name: Laura Piejko, PT, PhD
- Phone Number: 0322075310
- Email: l.piejko@awf.katowice.pl
Study Locations
-
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Poland, 40-065
- Department of Clinical Physiotherapy, Jerzy Kukuczka Academy of Physical Education in Katowice, 72A Mikolowska Street
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Principal Investigator:
- Anna Polak, Prof.
-
Contact:
- Anna Polak, Prof.
- Phone Number: 0322075301
- Email: a.polak@awf.katowice.pl
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Katowice, Silesian Voivodeship, Poland, 42-300
- LASERPOLAK, 92 Slowackiego Street, Myszkow
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Principal Investigator:
- Anna Polak, Prof.
-
Contact:
- Anna Polak, Prof.
- Phone Number: + 48 608519262
- Email: polanna@op.pl
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Rybnik, Silesian Voivodeship, Poland, 44-200
- Salus Care Center, 12 Jastrzebska Street
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Principal Investigator:
- Anna Polak, Prof.
-
Contact:
- Violetta Dytko, MSc
- Phone Number: + 48 601873608
- Email: centrumopiekisalus@gmail.com
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Sub-Investigator:
- Violetta Dytko, MSc
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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:
|
long-term care treatment
|
|
Experimental: 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:
|
residential home care treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Questionnaire Assessment - EQ-5D-5L Scale
Time Frame: 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). |
From enrollment, during the study at 6 week and at the end of the study at 12 weeks
|
|
Planimetry
Time Frame: 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.
|
Form enrolment for every two weeks to the end of the study at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NSNS Scale
Time Frame: 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). |
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
Time Frame: From enrollment to the end of treatment at 12 weeks
|
In long-term care, the following costs will be taken into account primarily:
In home care (long-term nursing home care), the following costs will be taken into account primarily:
In both types of care, the following will also be taken into account:
The costs will be added up and calculated. |
From enrollment to the end of treatment at 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPIAP/EPUAP Classification System
Time Frame: At / upon enrollment
|
NPIAP/EPUAP Classification System is used to classify pressure ulcers according to their severity (Stages I-IV) based on the depth of tissue damage and clinical characteristics. A stage I pressure ulcer is characterized by non-blanching redness of the skin without skin disruption. A stage II pressure ulcer has partial loss of dermal thickness, while a stage III pressure ulcer has complete loss of skin thickness. A stage IV pressure ulcer is characterized by extensive tissue destruction, exposing muscles, tendons, and even bone (with the possibility of lesions extending deeper into these structures). The international NPIAP/EPUAP Classification System grades the severity of pressure ulcers (bedsores) based on the depth of soft tissue damage and anatomical tissue loss. The staging values run from Stage 1 (minimum) to Stage 4 (maximum), where higher scores mean a worse outcome and more profound tissue destruction. A physician will assess the severity of the pressure ulcer. |
At / upon enrollment
|
|
MNA assessment
Time Frame: At / upon enrollment
|
Mini Nutritional Assessment (MNA) - a validated screening tool used to evaluate nutritional status in older adults through dietary assessment, anthropometric measurements, general health evaluation, and functional assessment. The scale allows for a maximum of 30 points, and the results are interpreted as follows: 24-30 points - adequate nutrition, 17-23.5 points - risk of malnutrition, <17 points - malnutrition. |
At / upon enrollment
|
|
GDS-30 Scale
Time Frame: At / upon enrollment
|
Geriatric Depression Scale (GDS-30) - a 30-item self-report questionnaire designed to screen for depressive symptoms in older adults and assess their severity. The following are assessed: emotional well-being, interest in life, energy and motivation, self-esteem, and feelings of hopelessness or sadness. The results are interpreted as follows: 0-9 points - no depression or depression unlikely, 10-19 points - mild to moderate depression (deepening diagnostics is recommended), 20-30 points - severe depression (referral to a psychiatrist and possible treatment should be initiated). |
At / upon enrollment
|
|
MMSE
Time Frame: At / upon enrollment
|
Mini-Mental State Examination (MMSE) - a widely used cognitive screening test that assesses orientation, memory, attention, language, and visuospatial abilities to identify cognitive impairment. The assessment will be performed by a physician. This scale assesses six areas of cognitive function: orientation in time (date, day of the week, month), orientation in place (name of the patient's location, floor of the building, city, province), memorization (repeating given words), concentration and counting, recall (repeating given words after a few minutes), language and executive functions (naming objects, repeating sentences, understanding instructions, reading, writing, drawing). The results are summed and interpreted as follows: 27-30 points - no cognitive impairment, 24-26 points - mild cognitive impairment, 18-23 points - moderate cognitive impairment, ≤17 points - significant impairment (suspected dementia). |
At / upon enrollment
|
|
Barthel Index
Time Frame: At / upon enrollment
|
Barthel Index - an instrument used to evaluate a patient's level of independence in activities of daily living (ADLs), including feeding, bathing, dressing, toileting, transfers, mobility, and continence. The patient's independence is assessed during activities such as eating, transferring (e.g., from bed to a chair), dressing, using the toilet, washing and grooming, climbing stairs, mobility (moving a distance of 50 meters), and controlling urine and stool. The results are interpreted as follows: 0-20 points - complete dependence (patient requires full care), 21-60 points - significant dependence (significant assistance with most activities), 61-90 points - moderate dependence (assistance with some activities), 91-99 points - minimal dependence (little assistance or supervision), 100 points - complete independence (patient performs all activities independently). |
At / upon enrollment
|
|
Waterlow Scale
Time Frame: At / upon enrollment
|
Waterlow Scale - a comprehensive pressure ulcer risk assessment tool that considers multiple patient-related factors, including age, body build, mobility, nutritional status, continence, skin condition, and comorbidities. It assesses the following risk factors for pressure ulcers: patient age, gender (female patients receive additional points), body composition (height and weight; BMI), skin condition (e.g., presence of pressure ulcers, dry, moist, or damaged skin), mobility, urinary and/or fecal incontinence, appetite and nutrition, neurological disorders (e.g., paralysis, stroke, multiple sclerosis), acute and chronic diseases (e.g., diabetes, heart failure, cancer, respiratory diseases), medications (e.g., steroids, chemotherapy), and previous surgical procedures (major surgeries lasting >2 hours). Each factor is assigned a specific number of points and ≥20 points means high risk of pressure ulcers. |
At / upon enrollment
|
|
Braden Scale
Time Frame: At / upon enrollment
|
Braden Scale - a validated tool used to assess the risk of pressure ulcer development by evaluating six domains: sensory perception, skin moisture, physical activity, mobility, nutrition, and friction/shear. The Braden Scale is one of the most commonly used tools for assessing the risk of pressure ulcers in elderly patients, particularly those who are chronically ill, immobilized, or hospitalized. This scale assesses six areas of pressure ulcer risk: sensory perception (the patient's ability to respond to pressure-induced discomfort), skin moisture (exposure of the skin to moisture, e.g., sweat, urine, feces), activity (level of physical activity, e.g., walking, lying down), mobility (the ability to change and control body position), nutrition (nutrition type and quality), and friction and shear forces (the effect of body movement relative to the ground). The maximum score is 23, and the lower the score, the greater the risk of pressure ulcers |
At / upon enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anna Polak, Prof., The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Resolution no. 11-VI/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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