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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01308-41 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care group | Active Comparator |
| |
| Enhanced care group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced post-diagnostic support | Behavioral | Nurse-led and psychologist consultation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle AUDO, Pr | Contact | +33 0140 02 14 30 | isabelle.audo@inserm.fr | |
| Benoit Blanchard | Contact | +33 0140021430 | bblanchard@15-20.fr |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Audo, Pr | CRMR Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts | Recruiting | Paris | ĂŽle-de-France Region | 75012 | France |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2025 | Oct 6, 2025 |
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| Usual Care | Behavioral | Standard ophthalmologist consultation with optional psychologist consultation |
|
| 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. | 15 days, 6 months and 12 months after diagnosis |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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