The goal of this clinical study is to learn if Pomegranate Seed Oil supplementation works to combat urinary tract infections, recurrenturinary tract infections, or pneumonia and contributes to the tapering or discontinuation of antipsychotics in palliative care patients withadvanced dementia. The main questions it aims to answer are: * Does Pomegranate Seed Oil supplementation reduce the likelihood of developing a urinary tract infection? * Does Pomegranate Seed Oil supplementation prevent UTI reinfection? * Does Pomegranate Seed Oil supplementation reduce the likelihood of pneumonia? * Does Pomegranate Seed Oil supplementation contribute to the tapering or discontinuation of antipsychotics? Researchers will compare Pomegranate Seed Oil to care-as-usual to see if Pomegranate Seed Oil supplementation can increase quality of care in palliative care patients with advanced dementia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
18
Besides Pomegranate Seed Oil Supplementation, all participants will continue to receive all ongoing care and treatments, including following the Mediterranean diet, monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation, occupational therapy and music therapy, without any modification
All participants will continue to receive all ongoing care and treatments, including a Mediterranean diet,monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation,occupational therapy and music therapy, without any modification
Palliative Care Centre "Panagia Glykofilousa"
Thessaloniki, Central Macedonia, Greece
Number of Palliative Care Patients with Advanced Dementia with Urinary Tract Infections (UTIs)
Urinary Tract Infections were diagnosed using the revised McGeer criteria for the diagnosis of UTIs in Stone et al. (2012): Criteria from both 1 and 2 1. At least 1 of the following: Acute dysuria or acute pain, swelling, or tenderness of the testes, epididymis, or prostate OR Fever or leukocytosis and at least 1 of the following localizing urinary tract sub-criteria: Acute costovertebral angle pain or tenderness Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency In the absence of fever or leukocytosis, then 2 or more of the following: Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency 2. One of the following: At least 10\^5 cfu/mL of no more than 2 species of microorganisms in a voided urine sample At least 10\^2 of any number of organisms in a specimen collected by in-and-out catheter
Time frame: From enrollment to the end of treatment at 24 weeks
Number of Palliative Care Patients with Advanced Dementia with Reccurent Urinary Tract Infections (rUTIs)
Recurrent UTIs were classified as more than one UTI diagnosed in a single patient based on the criteria proposed in Stone et al. (2012) as described previously.
Time frame: From enrollment to the end of treatment at 24 weeks
Number of Palliative Care Patients with Advanced Dementia with Antipsychotic Deprescribing (Dose Reduction or Discontinuation)
Time frame: From enrollment to the end of treatment at 24 weeks
Number of Palliative Care Patients with Advanced Dementia Diagnosed with Pneumonia
As in Stone et al. (2012): All 3 criteria must be present: 1. Interpretation of a chest radiograph as demonstrating pneumonia or the presence of a new infiltrate 2. At least 1 of the following respiratory subcriteria 1. New or increased cough 2. New or increased sputum production 3. O2 saturation \<94% on room air or a reduction in O2 saturation of \>3% from baseline 4. New or changed lung examination abnormalities 5. Pleuritic chest pain 6. Respiratory rate of ≥25 breaths/min 3. At least 1 of the following criteria 1. Fever 2. Leukocytosis 3. Acute change in mental status from baseline and either disorganized thinking or altered level of consciousness 4. Acute functional decline
Time frame: From enrollment to the end of treatment at 24 weeks
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