An interventional study of Enhanced post-diagnostic support and Usual Care in Retinitis Pigmentosa (RP), sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Supportive care
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.
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.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 80 is above the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Usual Care
Behavioral: Enhanced post-diagnostic support
Nurse-led and psychologist consultation
Standard ophthalmologist consultation with optional psychologist consultation
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.
Time frame: 12 months
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).
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
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.
Time frame: 15 days, 6 months and 12 months after diagnosis
Plan to share: Undecided
Started Dec 2025 (actual). Primary completion is estimated for Jan 2028, 25 months after the start.
Of 30 interventional studies with no phase under Retinitis Pigmentosa, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 154. This study's planned 25 months is below that.
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts