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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorThe Jerzy Kukuczka Academy of Physical Education in Katowice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial design

Design model

Single group

Treatments tested in this trial

  • residential home care treatment

    Behavioral

    residential home care treatment

  • long-term care treatment

    Behavioral

    long-term care treatment

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: GE-1Experimental treatment 1 intervention
Group B: GE-2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life Questionnaire Assessment - EQ-5D-5L Scale

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).

Time frame
From enrollment, during the study at 6 week and at the end of the study at 12 weeks
2

Planimetry

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.

Time frame
Form enrolment for every two weeks to the end of the study at 12 weeks

Secondary outcomes

1

NSNS Scale

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).

Time frame
From enrollment, during the study at 6 week and to the end of the study at 12 weeks
2

Costs of pressure ulcer prevention and treatment assessment

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.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

1

NPIAP/EPUAP Classification System

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.

Time frame
At / upon enrollment
2

MNA assessment

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.

Time frame
At / upon enrollment
3

GDS-30 Scale

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).

Time frame
At / upon enrollment
4

MMSE

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).

Time frame
At / upon enrollment

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