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NCT07830810Toborzás még nem indult

DialysisBot: AI Chatbot for Hemodialysis Self-Management

DialysisBot: Design, Implementation, and Evaluation of an AI-based Conversational Agent to Support Self-management in Patients Undergoing Hemodialysis

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 21.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

End-stage kidney disease requiring hemodialysis is a chronic condition with substantial clinical, functional, and psychosocial burden. Maintaining an adequate health status between dialysis sessions depends largely on patients' ability to self-manage key aspects of treatment, including fluid restriction, dietary control, and vascular access care. Adherence in this population remains frequently suboptimal, and elevated interdialytic weight gain (IDWG), hyperphosphatemia, and hyperkalemia are among the most common complications associated with non-adherence. DialysisBot is a multiplatform, artificial intelligence-based conversational agent designed to support hemodialysis patients in the day-to-day self-management of their disease. The system combines a generative large language model for natural dialogue management, a fine-tuned BERT classifier for recognizing the domain of each patient request (diet, fluid intake, vascular access care, or organizational aspects of dialysis), and a vector-similarity retrieval engine that limits every response to a clinically validated knowledge base preloaded by the research team and approved by the hospital institution. The system performs no autonomous web search. When the cosine similarity between a user query and the indexed reference documents falls below a predefined threshold, the system withholds a clinical answer and instead informs the patient that it cannot respond, directing them to contact healthcare staff; this mechanism is the main technical safeguard against hallucinated or unvalidated responses. This is a prospective experimental pilot study evaluating the feasibility, acceptability, impact, and user satisfaction associated with DialysisBot as a self-management support tool for patients undergoing hemodialysis. Secondary objectives include assessing support for dietary management (phosphorus, potassium, and sodium restriction), support for interdialytic fluid intake control, whether system-provided guidance on vascular access management (arteriovenous fistula and central venous catheter) is put into practice and consistent with current standards of care, the impact on treatment adherence, and the barriers, facilitators, and overall user experience associated with the intervention. The study is organized into two methodological phases: a quantitative longitudinal phase (T0 baseline, T1 at 1 month, T2 at 3 months) using standardized patient-reported outcome measures and routine clinical parameters, followed by a qualitative phase conducted after T2, based on semi-structured interviews analyzed through reflexive thematic analysis. A convenience sample of 20-40 adult patients undergoing chronic hemodialysis, recruited through a participating dialysis center and/or an online patient community, will be enrolled and trained on the application before use. As a pilot feasibility study, its results are intended to inform the design and sample size of future, larger-scale confirmatory trials.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
40 (tervezett)
Első benyújtás
2026. júl. 29.
Kezdés
2026. okt. 1.
Elsődleges befejezés
2026. nov. 1.
Fő szponzor
University of Rome Tor Vergata
NCT-szám
NCT07830810

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 40
  • 2026. okt. 1. és az elsődleges befejezés (2026. nov. 1.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • Significant cognitive impairment preventing use of the application

Életkor

  • Age under 18 years

Egyéb

  • Significant inability to use digital tools
  • Absence of signed informed consent

Kiket keres a vizsgálat

  • Age ≥ 18 years
  • Patients undergoing chronic hemodialysis treatment
  • Availability of a compatible digital device (smartphone, tablet, or computer)
  • Adequate understanding of the Italian language
  • Sufficient basic digital literacy
  • Signed informed consent A purposive subsample (n = 10-15) of enrolled participants will additionally take part in semi-structured qualitative interviews at the end of the study.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Centro Dialisi MolfettaMolfettaOlaszországIsmeretlen állapot

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