Implementation and Evaluation of a Post-Diagnostic Announcement Protocol at the CRMR RefeRet, Quinze-Vingts Hospital
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: Enhanced post-diagnostic support, Usual Care.
- Who it may be relevant to
- Registry conditions: Retinitis Pigmentosa (RP). Basic parameters: 18 years — 65 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
- France
- 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
Implementation and Evaluation of a Post-diagnostic Announcement Protocol at the CRMR RefeRet of the Quinze-Vingts National Ophthalmology Hospital
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.
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.
Interventions
- Behavioral Enhanced post-diagnostic support
Nurse-led and psychologist consultation - Behavioral Usual Care
Standard ophthalmologist consultation with optional psychologist consultation
Primary outcome measures
- Patient Satisfaction via PREM at 12 months [Time frame: 12 months]
Secondary outcome measures (2)
- Psychological impact after post-diagnostic support via HADS [Time frame: 15 days, 6 months and 12 months after diagnosis]
- Feasibility and staff experience of implementing enhanced post-diagnostic support via RETEX and observation log [Time frame: 15 days, 6 months and 12 months after diagnosis]
Eligibility criteria
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
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
- Supportive care
Study locations
France · 1 center
- Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts — Paris
Identifiers
NCT: NCT07292987 · P25-02 · 2025-A01308-41