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Clinical Trials in France / NCT07292987
Recruiting Not applicable

Implementation and Evaluation of a Post-Diagnostic Announcement Protocol at the CRMR RefeRet, Quinze-Vingts Hospital

NCT07292987 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Phase
Not applicable
Started
2025-12-01
Last updated
2026-02-10

Condition(s) studied

Retinitis Pigmentosa (RP)

Investigational drug(s) / intervention(s)

Enhanced post-diagnostic supportUsual Care

Enhanced post-diagnostic support: Nurse-led and psychologist consultation

Usual Care: Standard ophthalmologist consultation with optional psychologist consultation

Study summary

This study explores whether adding early nurse-led and psychological support after the diagnosis of retinitis pigmentosa (RP) can improve patient experience and emotional well-being. RP is a rare, progressive eye disease often diagnosed after a long and difficult process, and receiving the diagnosis can be emotionally distressing.

Eighty newly diagnosed adults will be randomly assigned to either usual care or an enhanced pathway that includes early follow-up with a nurse, structured emotional monitoring, and a psychologist visit at six months.

The study aims to determine if this structured support improves patient satisfaction and reduces anxiety and depression compared with standard care.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosed with retinitis pigmentosa (RP) and followed at the Quinze-Vingts Rare Eye Disease Center, with diagnosis made after the project begins * Aged 18 to 65 years * Male or female * French-speaking * Have a phone number * Reside in France Exclusion Criteria: * Pregnant women * Participants enrolled in a therapeutic clinical trial within the past 12 months * Individuals deprived of liberty by judicial or administrative decision * Adults under legal protection or unable to provide informed consent * Individuals with other medical conditions or taking treatments that could interfere with study evaluations

Primary outcome measure(s)

  • Patient Satisfaction via PREM at 12 months — 12 months
    Difference in patient satisfaction via PREM (Patient Reported Experience Measure) at 12 months between the two arms. Items were rated on a 5-point Likert scale ranging from 1 (extremely worse than expected) to 5 (better than expected). Higher scores indicate a better perceived quality of care and psychological support.

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts Paris Île-de-France Region Recruiting

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Other trials for the same condition

Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Gene Therapy (SPVN20) in Subjects With Rod-Cone Dystrophy Recruiting
Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07292987 on ClinicalTrials.gov ↗ ← All trials in France