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

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

Recruiting
18-65 years
All
Phase N/A

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Overview

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.

Description

Retinitis pigmentosa (RP) is a rare genetic disease causing progressive vision loss. The announcement of diagnosis is a key moment that may trigger anxiety or depression, yet post-diagnostic care in ophthalmology often remains limited to medical information.

This prospective, monocentric, randomized study at the Quinze-Vingts National Ophthalmology Hospital tests a structured post-diagnostic support pathway that combines early nurse-led follow-up and systematic psychological support.

Eighty newly diagnosed patients aged 18-65 will be randomized into two parallel groups. The experimental group will receive early nurse consultations at 15 days and 6 months, psychological follow-up at 6 months, and repeated HADS assessments. The control group will receive usual care.

The primary outcome is patient satisfaction at 12 months (PREM). Secondary outcomes include changes in anxiety and depression (HADS) and feasibility feedback from nursing staff (RETEX).

Findings will inform the design of sustainable, multidisciplinary care models for rare eye diseases.

Eligibility

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

Study details
    Retinitis Pigmentosa (RP)

NCT07292987

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

1 February 2026

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