AI-Assisted Written Information in Chronic Anal Fissure (AF-AI)
3 september 2026 uppdaterad av: 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 Primary Chronic Anal Fissure: A Prospective Randomized Controlled Trial
This single-center, prospective, 1:1 randomized, parallel-group controlled superiority trial compares standard verbal counseling with AI-assisted written patient information in adults with primary chronic anal fissure receiving initial medical/conservative treatment.
The primary objective is to determine whether AI-assisted written information improves complete treatment adherence at day 14.
Secondary objectives include pain and discomfort outcomes, Patient Global Impression of Change, HEMO-FISS-QoL change, stool form change, additional healthcare visits, transition to interventional treatment, and patient satisfaction.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a single-center, prospective, 1:1 randomized, parallel-group, superiority-type controlled trial.
Adult patients with primary chronic anal fissure for whom initial medical/conservative treatment is planned will be enrolled.
Participants will be randomized in a 1:1 ratio to two groups.
The control group will receive standardized verbal counseling, whereas the intervention group will receive AI-assisted written patient information containing the same medical content and pre-validated by the investigators.
The medical treatment regimen will be identical in both groups, and the only difference will be the method of patient information delivery.
Assessments will be performed face-to-face at baseline, by telephone on days 7 and 14, and face-to-face at week 6.
The primary endpoint is complete treatment adherence at day 14.
Secondary outcomes include changes in pain and discomfort at days 7 and 14 and week 6, PGI-C, change in HEMO-FISS-QoL score, change in stool form, additional healthcare visits, need for interventional treatment, and patient satisfaction.
Studietyp
Interventionell
Inskrivning (Beräknad)
220
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Vedat Kaplan
- Telefonnummer: +905459045165
- E-post: vedat_kaplan_@hotmail.com
Studieorter
-
-
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Sanliurfa, Turkiet (Türkiye)
- Rekrytering
- Sanliurfa Education and Research Hospital
-
Kontakt:
- Vedat Kaplan
- Telefonnummer: +905459045165
- E-post: vedat_kaplan_@hotmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Age 18 years or older
- Clinical diagnosis of primary chronic anal fissure
- Initial medical/conservative treatment planned at first evaluation
- Ability to read and understand Turkish
- Reachable by telephone
- Provision of written informed consent
Exclusion Criteria:
- Acute anal fissure
- Suspicion or diagnosis of secondary fissure (including Crohn's disease, tuberculosis, HIV-related lesion, suspected malignancy, or atypical lateral fissure)
- Planned botulinum toxin, surgery, or another interventional treatment
- History of botulinum toxin or surgical treatment for anal fissure within the last 6 months
- Concomitant perianal abscess, fistula, advanced hemorrhoidal disease, or another significant anorectal pathology
- Pregnancy and early postpartum period
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: AI-assisted written patient information
Participants receive standardized medical treatment plus AI-assisted written patient information that contains the same medical content as the verbal counseling and has been pre-validated by the investigators.
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Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
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Aktiv komparator: Standardized verbal counseling
Participants receive standardized medical treatment plus standardized verbal counseling alone.
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Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Complete treatment adherence at Day 14
Tidsram: Day 14
|
Complete treatment adherence at Day 14, defined as a total adherence score of at least 5 out of 6 predefined treatment-behavior items: regular topical medication use, correct application to the target area, regular stool softener or fiber support, achievement of the water intake target, regular warm sitz bath or warm water application, and avoidance of excessive straining.
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Day 14
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain during defecation at Day 7
Tidsram: Day 7
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Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
|
Day 7
|
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Pain during defecation at Day 14
Tidsram: Day 14
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Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
|
Day 14
|
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Pain during defecation at Week 6
Tidsram: Week 6
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Pain during defecation assessed using a 0 to 10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
|
Week 6
|
|
Patient Global Impression of Change at Day 7
Tidsram: Day 7
|
Patient Global Impression of Change assessed on a 7-category ordinal scale: very much improved, much improved, a little improved, unchanged, a little worse, much worse, and very much worse.
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Day 7
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Patient Global Impression of Change at Week 6
Tidsram: Week 6
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Patient Global Impression of Change assessed on a 7-category ordinal scale: very much improved, much improved, a little improved, unchanged, a little worse, much worse, and very much worse.
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Week 6
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juli 2026
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
8 juli 2026
Först inskickad som uppfyllde QC-kriterierna
8 juli 2026
Första postat (Faktisk)
14 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SEAH-AF-AI
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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