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Not yet recruiting NCT07701798

AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease

No phase Interventional Symptomatic Hemorrhoidal Disease Hemorrhoids Grade I and II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-assisted written patient information, Standardized verbal counseling.
Who it may be relevant to
Registry conditions: Symptomatic Hemorrhoidal Disease, Hemorrhoids Grade I and II. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral AI-assisted written patient information
    Investigator-validated written patient information prepared with AI assistance and provided in addition to standard medical treatment.
  • Behavioral Standardized verbal counseling
    Standardized verbal counseling regarding medical treatment and lifestyle measures, provided in addition to standard medical treatment.

Primary outcome measures

  • Complete treatment adherence at Day 14 [Time frame: Day 14]
Secondary outcome measures (8)
  • Change in HEMO-FISS-QoL total score from baseline to Day 28 [Time frame: Baseline and Day 28]
  • Patient Global Impression of Change at Day 28 [Time frame: Day 28]
  • Time to symptom improvement [Time frame: Up to Day 28]
  • Change in pain/discomfort score from baseline to Day 28 [Time frame: Baseline and Day 28]
  • Change in bleeding symptom severity from baseline to Day 28 [Time frame: Baseline and Day 28]
  • Change in swelling symptom severity from baseline to Day 28 [Time frame: Baseline and Day 28]
  • Change in itching symptom severity from baseline to Day 28 [Time frame: Baseline and Day 28]
  • Change in soiling symptom severity from baseline to Day 28 [Time frame: Baseline and Day 28]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07701798 · SEAH-HD-AI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗