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

Implementation and Evaluation of a Post-diagnostic Announcement Protocol at the CRMR RefeRet of the Quinze-Vingts National Ophthalmology Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Retinitis Pigmentosa (RP)
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Enhanced post-diagnostic support

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle AUDO, Pr; Phone Number: +33 0140 02 14 30; Email: isabelle.audo@inserm.fr
• Study Contact Backup: Name: Benoit Blanchard; Phone Number: +33 0140021430; Email: bblanchard@15-20.fr

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75012
      • Recruiting
      • Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts
      • Principal Investigator: Isabelle Audo, Pr
      • Contact: DRCI; Phone Number: + 33 0140 02 17 38; Email: recherche@15-20.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care group	Behavioral: Usual Care; Standard ophthalmologist consultation with optional psychologist consultation
Experimental: Enhanced care group	Behavioral: Enhanced post-diagnostic support; Nurse-led and psychologist consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction via PREM at 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological impact after post-diagnostic support via HADS	Evaluation of the psychological impact of the enhanced post-diagnostic care. Longitudinal assessment of emotional well-being in the experimental group will be performed using the Hospital Anxiety and Depression Scale (HADS) at three key time points. Each subscale (anxiety and depression) ranges from 0 to 21, with higher scores indicating greater symptom severity (worse outcome).	15 days, 6 months and 12 months after diagnosis
Feasibility and staff experience of implementing enhanced post-diagnostic support via RETEX and observation log	Nursing staff will complete a RETEX (Retour d'Expérience) questionnaire to assess the feasibility of the enhanced post-diagnostic care. The questionnaire evaluates challenges such as physician presence, adequacy of tools and setting, respect for patient privacy, communication with other staff, and consultation duration. The RETEX questionnaire consists of 11 dichotomous (Yes/No) items completed by nursing staff. Total score ranges from 0 to 11. Higher scores indicate greater perceived emotional and/or organizational burden, whereas lower scores indicate better feasibility and professional comfort.	15 days, 6 months and 12 months after diagnosis

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Investigators: Principal Investigator: Isabelle Audo, Pr, CRMR Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Eye Diseases; Eye Diseases, Hereditary; Retinal Diseases; Retinal Dystrophies; Retinal Degeneration; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinitis Pigmentosa
• Other Study ID Numbers: P25-02; 2025-A01308-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No