Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psycholog… (NCT07370961) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study to Evaluate the Impact of a Multidisciplinary Approach (Pharmacological and Psychological) in the Treatment of Chronic Kidney Disease-Associated Pruritus
Italy16 participantsStarted 2024-06-01
Plain-language summary
This is a single-center, pilot, randomized, open-label, non-profit interventional study designed to evaluate the impact of a multidisciplinary approach on chronic kidney disease-associated pruritus (CKD-aP) in patients undergoing chronic extracorporeal hemodialysis.
Twenty adult, clinically stable hemodialysis patients with moderate to severe uremic pruritus will be enrolled and randomized to receive either standard of care alone or standard of care plus a structured psychological intervention. The primary objective is to assess the change in pruritus-related quality of life after 6 months, measured by the KDQOL-SF questionnaire. Secondary objectives include evaluation of pruritus severity, quality of life, sleep quality, psychological distress, patient engagement, clinical and biochemical parameters, and exploration of patients' psychological experience over time.
The study aims to provide preliminary evidence on the effectiveness of integrating psychological support into the management of CKD-associated pruritus in the hemodialysis population.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* KDQOL-SF™ 1.3 score ≥ 3 (corresponding to the presence of the symptom in the last 4 weeks, rated as "moderately bothered")
* On chronic hemodialysis for at least 3 months and clinically stable
* Signed informed consent for participation in the study
Exclusion Criteria:
* Refusal to provide informed consent
* Age \< 18 years
* KDQOL-SF™ 1.3 score \< 3
* Pruritus secondary to dermatologic diseases, autoimmune diseases with skin involvement (e.g. SLE, scleroderma, vasculitis, etc.), hepatobiliary diseases causing cholestatic jaundice, malignancies, or uncontrolled endocrine disorders
* Active substance abuse
* Severe mental illness or severe cognitive impairment (e.g. active psychosis, dementia, etc.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to 6 months in the pruritus intensity-related item of the Kidney Disease Quality of Life - Short Form (KDQOL-SF) questionnaire.
Timeframe: 6 months
Trial details
NCT IDNCT07370961
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia