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AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease (HD-AI)

8. juli 2026 opdateret af: Vedat Kaplan, Sanliurfa Education and Research Hospital

Effect of AI-Assisted Written Patient Information on Medical Treatment Adherence and Short-Term Patient-Reported Outcomes in Symptomatic Hemorrhoidal Disease: A Prospective Randomized Controlled Trial

This single-center, prospective, parallel-group, 1:1 randomized controlled trial compares standardized verbal counseling with AI-assisted written patient information in adults with symptomatic hemorrhoidal disease receiving initial conservative/medical treatment. The primary objective is to determine whether AI-assisted written information improves complete treatment adherence at day 14. Secondary objectives include quality-of-life change, Patient Global Impression of Change, time to symptom improvement, change in pain/discomfort scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a single-center, prospective, parallel-group, 1:1 randomized controlled trial in adults with symptomatic hemorrhoidal disease for whom conservative/medical treatment is planned at the initial evaluation. After baseline assessment, participants will be randomized by sealed-envelope or computer-based block randomization into two groups. The control group will receive standardized verbal counseling. The intervention group will receive investigator-validated AI-assisted written patient information containing the same medical content. Standard medical treatment will be identical in both groups, and the only difference will be the method of information delivery. Participants will be assessed at baseline, day 7, day 14, and day 28. The primary endpoint is complete treatment adherence at day 14. Secondary outcomes include change in HEMO-FISS-QoL, PGI-C response, time to symptom improvement, change in pain/discomfort visual analog scale scores, change in bleeding, swelling, itching, and soiling symptoms, and unplanned repeat healthcare visits.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

220

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 18 years or older
  2. Diagnosis of symptomatic hemorrhoidal disease in the outpatient clinic
  3. Conservative/medical treatment planned at first evaluation
  4. Ability to read and understand Turkish
  5. Reachable by telephone
  6. Provision of written informed consent

Exclusion Criteria:

  1. Planned office procedure or surgery
  2. Emergency conditions such as thrombosed external hemorrhoid, strangulation, or massive bleeding
  3. Concomitant anal fissure, anal fistula, perianal abscess, inflammatory bowel disease, or suspicion of anal/colorectal malignancy
  4. History of hemorrhoidal intervention or surgery within the last 3 months
  5. Severe cognitive impairment, severe visual problem, or communication barrier
  6. Pregnancy and postpartum period
  7. Serious systemic conditions that would prevent completion of study follow-up

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standardized verbal counseling
Participants receive standardized medical treatment plus standardized verbal counseling alone.
Adfærdsmæssigt: Standardized verbal counseling
Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.
Eksperimentel: AI-assisted written patient information
Participants receive standardized medical treatment plus investigator-validated AI-assisted written patient information containing the same medical content as the verbal counseling.
Adfærdsmæssigt: AI-assisted written patient information
Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete treatment adherence at Day 14
Tidsramme: Day 14
Complete treatment adherence at Day 14, defined as full adherence to the prescribed medical treatment and lifestyle recommendations according to the study follow-up form.
Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HEMO-FISS-QoL total score from baseline to Day 28
Tidsramme: Baseline and Day 28
Change in health-related quality of life measured by the HEMO-FISS-QoL total score from baseline to Day 28.
Baseline and Day 28
Patient Global Impression of Change at Day 28
Tidsramme: Day 28
Patient Global Impression of Change assessed at Day 28.
Day 28
Time to symptom improvement
Tidsramme: Up to Day 28
Time from baseline to the first patient-reported improvement in hemorrhoidal symptoms, measured in days.
Up to Day 28
Change in pain/discomfort score from baseline to Day 28
Tidsramme: Baseline and Day 28
Change in pain or discomfort assessed using a Visual Analog Scale from baseline to Day 28.
Baseline and Day 28
Change in bleeding symptom severity from baseline to Day 28
Tidsramme: Baseline and Day 28
Change in patient-reported bleeding symptoms from baseline to Day 28.
Baseline and Day 28
Change in swelling symptom severity from baseline to Day 28
Tidsramme: Baseline and Day 28
Change in patient-reported swelling symptoms from baseline to Day 28.
Baseline and Day 28
Change in itching symptom severity from baseline to Day 28
Tidsramme: Baseline and Day 28
Change in patient-reported itching symptoms from baseline to Day 28.
Baseline and Day 28
Change in soiling symptom severity from baseline to Day 28
Tidsramme: Baseline and Day 28
Change in patient-reported soiling symptoms from baseline to Day 28.
Baseline and Day 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanliurfa Education and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SEAH-HD-AI

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared because this is a single-center study involving sensitive patient-level clinical data, and there is no pre-specified institutional mechanism for external data sharing. Only aggregated, de-identified study results will be reported.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hæmorider Grad I og II

Kliniske forsøg med AI-assisted written patient information

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Argentina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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