Retinitis Pigmentosa (RP)RP-DIAGNCT07292987
Implementation and Evaluation of a Post-Diagnostic Announcement Protocol at the CRMR RefeRet, Quinze-Vingts Hospital
A study testing Enhanced post-diagnostic support in people with Retinitis Pigmentosa (RP), run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Retinitis Pigmentosa (RP)
- What is being tested?
- Enhanced post-diagnostic support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts
Paris, Île-de-France Region, 75012
DRCI, + 33 0140 02 17 38, recherche@15-20.fr
Isabelle Audo, Pr
About this study
Official title: Implementation and Evaluation of a Post-diagnostic Announcement Protocol at the CRMR RefeRet of the Quinze-Vingts National Ophthalmology 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.
Read the 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.
- Conditions
- Retinitis Pigmentosa (RP)
- Being tested
- Enhanced post-diagnostic support, Usual Care
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced post-diagnostic supportBehavioural
Nurse-led and psychologist consultation
Usual CareBehavioural
Standard ophthalmologist consultation with optional psychologist consultation
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | Active comparator | Not described Receives: Behavioral: Usual Care |
| Enhanced care group | Experimental | Not described Receives: Behavioral: Enhanced post-diagnostic support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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).
Measured: 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.
Measured: 15 days, 6 months and 12 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Dec 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis Pigmentosa (RP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Audo, Pr, Principal investigator, CRMR Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292987
- Sponsor's protocol ID
- P25-02
- Other IDs
- 2025-A01308-41
- Acronym
- RP-DIAG
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Post-diagnostic Announcement Protocol at the CRMR RefeRet of the Quinze-Vingts National Ophthalmology Hospital
- ClinicalTrials.gov ID
- NCT07292987
- Acronym / sponsor ID
- RP-DIAG / P25-02
- Conditions
- Retinitis Pigmentosa (RP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care group | Active comparator | Behavioral: Usual Care |
| Enhanced care group | Experimental | Behavioral: Enhanced post-diagnostic support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced post-diagnostic supportNurse-led and psychologist consultation | Behavioural | Enhanced care group |
| Usual CareStandard ophthalmologist consultation with optional psychologist consultation | Behavioural | Usual care group |
Primary outcome
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.
2 secondary outcomes
Psychological impact after post-diagnostic support via HADS
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
Time frame: 15 days, 6 months and 12 months after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Retinitis Pigmentosa (RP)
RecruitingPhase 2/3
Study to Evaluate the Efficacy of a Single Intravitreal Injection of RTx-015 in Participants With Retinitis Pigmentosa (PERCEPT)
Retinitis Pigmentosa (RP), Inherited Retinal Diseases
Active, not recruitingPhase 1/2
Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases
Retinitis Pigmentosa (RP), Extensive Macular Atrophy With Pseudodrusen (EMAP)
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
RecruitingPhase 1
Safety Evaluation Study of Pitavastatin PLGA Nano-particle for Retinitis Pigmentosa
Retinitis Pigmentosa (RP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Audo, Pr principal investigator
CRMR Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced post-diagnostic support in people with Retinitis Pigmentosa (RP), run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle AUDO, Pr (+33 0140 02 14 30, isabelle.audo@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction via PREM at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.