Clinical trial NCT04917146: Systemic Sclerosis' Relatives Reflex
Official title: "Family Caregiver Reflex": Family Support for Patients Followed for Systemic Sclerosis - Pilot Study Evaluating the Experience and Role of Family Caregivers in Order to Identify and Include Them in Therapeutic Educational Programs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Caregivers
Keywords: Systemic sclerosis
Relatives caregivers
Therapeutic education program
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: FSMR FAI2R
name: Ministère des solidarités et de la santé
First posted: 2021-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants:

relatives of patients suffering from Systemic Scleroderma

Two possible inclusion methods:

1. At the hospital, via health professionals (doctor, nurse, social worker, etc.) who identify the loved one accompanying the patient during a consultation or hospitalization;
2. Via the French Scleroderma Association - ASF (call for participation)

They will be presented with the study by the recruiting psychologist or education nurse and given an information note and consent to participate. Patients will also be presented with an information letter and consent to participate .

Brief summary: 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.

Detailed description: Exploratory study with family caregivers of patients suffering from Systemic Sclerosis (SSc).

This research work will allow to better understand the experiences and needs of these very particular caregivers, in order to offer them specific educational support and workshops.

It should also allow healthcare teams to develop a "family caregiver reflex", especially in the context of SSc disease to identify and include PAs in PTE programs.

Primary objectives:

Identify caregivers in the SCS patient's family circle: in order to analyze their profile and assess their needs, expectations, projects and difficulties:

* Identify who are the caregivers of SSc people: epidemiological data, profiles of SSc patients followed in rheumatology and Internal medicine departments of Cochin hospital (sex, age, professional activity, possible presence of young people in the entourage, etc.);
* assess the assistance provided by the caregivers: type and specificity;
* Specify the experience and feelings of the caregivers in relation to this aid (positive or negative impact)
* Identify fragile-vulnerable caregivers .

Secondary objectives:

Develop, from this data, educational tools to share with the other members of the FSMR FAI2R and specifically dedicated to the caregivers of SSc patients:

* "Caregiver reflex" tool intended for professionals to better identify and identify caregivers of SSc patients;
* Specific interview guide for the educational diagnosis of caregivers;
* Examples of educational workshops for caregivers meeting identified needs (workshop experienced by the illness of the other, stress management, fatigue, dietary advice, lifestyle, to assist persons in administrative and social procedures...)

Eligibility criteria: Inclusion Criteria:

* Relatives caregivers of patients suffering from Systemic Scleroderma (family, friends, neighbours);
* Be at least 18 years old;
* Not being the patient's professional caregiver;
* Have signed the informed consent to participate.

Exclusion Criteria:

* Inability to answer questionnaires (language, cognitive disorders, etc.).
* under curatorship or tutorship
* with State medical care (AME)

Primary outcomes:
measure: Questionnaire
timeFrame: Inclusion visit 1 day
Secondary outcomes:
measure: Questionnaire
timeFrame: Inclusion visit 1 day
measure: Questionnaire SF36
timeFrame: Inclusion visit 1 day
measure: Questionnaire
timeFrame: Inclusion visit 1 day
measure: Questionnaire
timeFrame: Inclusion visit 1 day
measure: Questionnaire
timeFrame: Inclusion visit 1 day
Other outcomes:
Locations:
city: Paris
country: France
facility: Rhumatology Service
Study officials:
affiliation: Cochin Hospital - APHP
name: Janine-Sophie Giraudet-Le Quintrec, MD
role: PRINCIPAL_INVESTIGATOR
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