NCT07292987

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Jan 2028

First Submitted

Initial submission to the registry

November 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

November 25, 2025

Last Update Submit

February 9, 2026

Conditions

Retinitis Pigmentosa (RP)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Psychological impact after post-diagnostic support via HADS

    15 days, 6 months and 12 months after diagnosis

  • Feasibility and staff experience of implementing enhanced post-diagnostic support via RETEX and observation log

    15 days, 6 months and 12 months after diagnosis

Study Arms (2)

Usual care group

ACTIVE COMPARATOR
Behavioral: Usual Care

Enhanced care group

EXPERIMENTAL
Behavioral: Enhanced post-diagnostic support

Interventions

Enhanced post-diagnostic supportBEHAVIORAL

Nurse-led and psychologist consultation

Enhanced care group
Usual CareBEHAVIORAL

Standard ophthalmologist consultation with optional psychologist consultation

Usual care group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts

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

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Isabelle Audo, Pr

    CRMR Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle AUDO, Pr

CONTACT

+33 0140 02 14 30isabelle.audo@inserm.fr

Benoit Blanchard

CONTACT

+33 0140021430bblanchard@15-20.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 18, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

FR(1)