Implementation and Evaluation of a Post-diagnostic Announcement Protocol at the CRMR RefeRet of the Quinze-Vingts National Ophthalmology Hospital
Phase: NA
Conditions: Retinitis Pigmentosa (RP)
Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Summary of the Study Protocol 
 
Version v.1 dated 10.06.2025 
2025-A01308-41 
Page 1 of 2 
Title 
Implementation and evaluation of a post-diagnostic announcement protocol at the 
Neuroretinal Disease Reference Center RefeRet, Quinze-Vingts Hospital. 
 
Acronyme 
RP-DIAG 
 
Principal Investigator 
Pr Isabelle AUDO, CRMR 
 
Sponsor 
Quinze-Vingts National Vision Hospital (HNV des 15-20) 
 
Study Justification 
 
Retinitis pigmentosa (RP), the main genetic retinal dystrophy, affects approximately 1 in 
4,000 people and is characterized by progressive vision loss. Receiving the diagnosis is 
often challenging: the long medical journey and lack of clear guidance increase anxiety, 
sometimes leading to a break in follow-up care. Unlike in oncology, there are no 
established post-diagnosis recommendations in this field. The current process at the 
Quinze-Vingts National Vision Hospital is limited to a consultation with the 
ophthalmologist, without formal coordination of psychological or nurse support. The RP-
DIAG study aims to structure post-diagnosis follow-up (nurse and psychological support) 
and to evaluate its feasibility, impact, and potential for long-term implementation and 
adaptation in other rare disease centers. 
 
Study Objectives 
1. To evaluate a new post-diagnostic paramedical support pathway (nurse and 
psychological support) in order to improve care for patients with retinitis 
pigmentosa (RP). 
2. To collect data on patients’ psychological experience after diagnosis using the 
Hospital Anxiety and Depression Scale (HADS). 
3. To assess the feasibility of generalizing the support pathway, including the 
workload for clinical teams, using the RETEX questionnaire, and to provide the 
basis for a standardized, sustainable post-diagnostic protocol that could 
potentially be reproduced in other ophthalmology rare disease centers. 
 
Study Category and Type 
Pilot study, RIPH2 category. 
Randomized, prospective, longitudinal, monocentric comparative study. 
 
Evaluation Criteria and 
Outcome Measures 
1 .  Patient-perceived satisfaction: Measured using the PREM (Patient-Reported 
Experience Measure) questionnaire, comparing: 
− 
An experimental group receiving the structured nurse/psychological follow-up 
− 
A control group receiving usual care 
Measurement will be performed at 12 months. 
2.  Psychological impact: Change in HADS (Hospital Anxiety and Depression Scale) 
scores in the experimental group at 15 days, 6 months, and 12 months. 
3.  Paramedical team feedback: Collected via an observation log (RETEX questionnaire) 
to identify difficulties (organizational, logistical, interpersonal) and qualitatively and 
quantitatively evaluate the benefits of the intervention. 
 
 
Inclusion Criteria 
- Diagnosed with retinitis pigmentosa and receiving care at the Rare Disease Reference 
Center (CRMR), with diagnosis disclosure occurring after the project’s initiation.                    
- Aged between 18 and 65 years. 
- Male or female. 
- French-speaking. 
- Has a valid telephone number. 
- Resident of France. 
 
Exclusion Criteria 
- Individuals enrolled in a therapeutic clinical trial (for 12 months) 
- Individuals deprived of liberty by judicial or administrative decision (art. L1121-6 of the 
French Public Health Code) 
-  Adults under legal protection measures or unable to provide consent (art. L1121-8 of 
the French Public Health Code) 
- Individuals with other medical conditions or taking treatments likely to interfere with 
study assessments 
- Participants unable to attend all study visits 
 
 

Summary of the Study Protocol 
 
Version v.1 dated 10.06.2025  
2025-A01308-41 
Page 2 of 2 
- Pregnant, postpartum, or breastfeeding women (according to art. L1121-5 of the 
French Public Health Code). 
Criteria for early 
withdrawal or study 
discontinuation 
- Occurrence of other medical conditions or treatments which could interfere with the 
planned assessments of the study; 
- A participant may decide at any time to withdraw from the study; 
- A participant may also be withdrawn from the study by the investigator. 
 
Constraints and Risks 
This pilot study does not present any foreseeable medical risks. 
 
Population  
Target population: Adult patients diagnosed with retinitis pigmentosa (RP) who meet the 
inclusion 
criteria 
– 
first 
encounter 
with 
the 
name 
of 
their 
condition. 
Sample: 80 patients (40 in the experimental group, 40 in the control group). 
Randomization: Performed using the RedCAP software. 
 
Study Procedure 
Experimental Group (n=40) 
1. Visit 1 (Diagnosis Announcement): Ophthalmologist consultation; project 
information; optional initial discussion with the nurse. 
2. Consent Collection 
3. Visit 2 (Day 15): Nurse consultation (in-person or by phone, ~1 hour) to explain 
the disease and procedures, and assess emotional state (HADS-1). 
4. Visit 3 (6 months): Nurse consultation (HADS-2); psychologist consultation 
offered. 
5. Visit 4 (12 months): Ophthalmology consultation; nurse consultation (HADS-3); 
PREM questionnaire to assess patient satisfaction. 
Control Group (n=40) 
• 
Usual care: Diagnosis consultation followed by a 12-month follow-up visit. At 
the 12-month visit, the patient completes the PREM questionnaire. No 
systematic nurse or psychological follow-up between diagnosis and the 12-
month visit, unless requested by the patient. 
Visit Schedule Summary 
Visits 
Day 0 
(Announcement) 
Day 15 
(V1) 
6 Months 
(V2) 
12 Months 
(V3) 
Informed Consent 
        X 
- 
- 
Control Group 
(Usual Care) 
PREM 
- 
- 
PREM 
Experimental 
Group (Enhanced 
Support) 
HADS 
HADS 
HADS + 
Psychologist 
HADS + 
PREM 
 
 
 
Planned Study Timeline 
Expected study start date: September 2025 
Participant involvement duration: 12 months 
Visit frequency: As detailed in the visit schedule above 
Expected inclusion period: 10 months (approximately 8 patients enrolled per month) 
Total study duration: 24 months 
 
Source of Funding 
The project is funded by the APRESO program of the GIRCI.