NCT04917146: RelativReflex

Systemic Sclerosis' Relatives Reflex

Completed Last updated 20 November 2025

What this trial tests

trial testing Self-administered questionnaires for relatives (caregivers=CG) in Systemic Sclerosis in 50 participants. Completed in 23 June 2022.

Timeline

23 June 2021

Primary endpoint
23 June 2022

23 June 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	23 June 2021
Primary completion	23 June 2022
Estimated completion	23 June 2022
Sites	1 location across France

Drugs / interventions tested

• Self-administered questionnaires for relatives (caregivers=CG)

Conditions studied

• Systemic Sclerosis — all drugs for Systemic Sclerosis →
• Caregivers — all drugs for Caregivers →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Systemic Sclerosis or Caregivers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Systemic sclerosis (SSc) is a rare, serious disease that is part of chronic inflammatory rheumatism.

It requires multidisciplinary care and a specific therapeutic patient education program.

SSc actually affects every member of the family, the patient as well as those close to him. It deeply affects each member of the family (increased fatigue, stress, social isolation, exhaustion, financial difficulties …) which gives rise to threats of vulnerability and modulates the balance of family relations.

However, there are very few studies on family SSc caregivers. We have raised the question about the experience and needs of caregivers in order to better support them.

The main purpose of this pilot study is to better understand the particularities of relatives (caregivers) of patients suffering from systemic sclerosis and will allow us to refine our knowledge about the assistance they provide for SSc patients and its impact on family caregivers :

* lived experience of the relatives (caregivers);
* physical, mental and socio-professional health of the relatives (caregiver);
* relationship between the relative (caregiver) and the patient.

The research will be carried out at Cochin Hospital, in collaboration with the French Scleroderma Association (ASF).

It will be offered to relatives of SSc patients identified by health team in the rheumatology or internal medicine department, as well as during consultations and patient education activities.

An information note and an informed consent will be given to each patient and his caregiver ; Self-questionnaires will then be offered to relatives.

They can fill them out while they are in the hospital, or at home and return the completed questionnaire.

Caregivers will be questioned about their quality of life, health, relationship with the patient and support situation.

They will also be asked for personal socio-demographic information concerning the patient.

The "caregiver reflex" project is part of the 2020-2022 mobilization and support strategy for caregivers "acting for the health of family caregivers", in which the establishment of a "caregiver reflex" among professionals health is put forward.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.