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NCT Number: NCT07292987

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

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Key information

Conditions

Retinitis Pigmentosa (RP) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts

Paris, Île-de-France Region, 75012, France

Location status: Recruiting

Location contact

DRCI

CONTACT

[email protected]

+ 33 0140 02 17 38

Isabelle Audo, Pr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced post-diagnostic support

Behavioral

Nurse-led and psychologist consultation

Usual Care

Behavioral

Standard ophthalmologist consultation with optional psychologist consultation

Primary outcomes

  1. Patient Satisfaction via PREM at 12 months

    Time frame: 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.

Secondary outcomes

  1. Psychological impact after post-diagnostic support via HADS

    Time frame: 15 days, 6 months and 12 months after diagnosis

    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).

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benoit Blanchard

CONTACT

[email protected]

+33 0140021430

Isabelle AUDO, Pr

CONTACT

[email protected]

+33 0140 02 14 30

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Registry information

Official study title

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

Acronym: RP-DIAG

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 18, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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