Retinitis Pigmentosa (RP)
Conditions
Brief summary
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
BEHAVIORALEnhanced post-diagnostic support
Nurse-led and psychologist consultation
BEHAVIORALUsual Care
Standard ophthalmologist consultation with optional psychologist consultation
Sponsors
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction via PREM at 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Psychological impact after post-diagnostic support via HADS | 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). |
| Feasibility and staff experience of implementing enhanced post-diagnostic support via RETEX and observation log | 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. |
Countries
France
Contacts
CONTACTIsabelle AUDO, Pr
CONTACTBenoit Blanchard
PRINCIPAL_INVESTIGATORIsabelle Audo, Pr
CRMR Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts
Outcome results
None listed