Systemic Sclerosis' Relatives Reflex

Study Overview
=================
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...)

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

Conditions
-----------------
Systemic Sclerosis, Caregivers

Intervention / Treatment
-----------------
* Other: Self-administered questionnaires for relatives (caregivers=CG)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caregivers (CG)<br>Caregivers of patients with systemic Scleroderma | Other: Self-administered questionnaires for relatives (caregivers=CG)<br>* Sociodemographic and medical information for the patient and the CG. SF36 questionnaire for the quality of life (physical, mental) of family CGs This assessment will be supplemented by specific questions relating to: physical health, emotional state, personal and leisure activities of the caregiver. The CG's knowledge and representations of the disease : questions adapted from the Brief-IPQ disease representation questionnaire. Questions will also focus on the caregiver's reactions to the patient's illness. We have constructed a questionnaire to assess the main areas of aid in the context of SSc: emotional, domestic help, administrative, medical, for trave (16 items and an open question). The CG Reaction Assessment-CRA questionnaire to assess the positive and negative dimensions of helping (24 items). It assesses five dimensions: self-esteem, financial impact, impact on health, impact on time and lack of family support. The reason for the assistance provided.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | Sociodemographic and medical information concerning the patient assisted Patients' sociodemographic and medical information will be collected: age, gender, family composition, family relationship with the family caregiver, length of the illness. | Inclusion visit 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | Socio-demographic information about the caregiver Sociodemographic information will be collected on the informal caregiver: age, sex, professional situation, seniority of the help. | Inclusion visit 1 day | 
| Questionnaire SF36 | Physical and mental health The SF36 questionnaire (Leplège et al., 1998) will be used to assess the quality of life of family caregivers. This widely used questionnaire is divided on 6 items assessing the physical and mental quality of life. This assessment will be supplemented by specific questions relating to: Physical health: presence of chronic pathologies, medical monitoring, taking treatment, health behaviors (diet, tobacco, alcohol); The emotional state; The personal and leisure activities of the caregiver. | Inclusion visit 1 day | 
| Questionnaire | The relationship with the patient The caregiver's knowledge and representations of the disease will be assessed using questions adapted from the Brief-IPQ disease representation questionnaire (Broadbent et al., 2006). Questions will also focus on the caregiver's reactions to the patient's illness. | Inclusion visit 1 day | 
| Questionnaire | Aid activities To date, there is no questionnaire to assess the aid activity in the context of chronic inflammatory rheumatism. The existing questionnaires on the subject being too often linked to situations of significant dependence, as in the context of neurodegenerative diseases, we have constructed a questionnaire to assess the main areas of aid in the context of SSc: emotional, domestic help , administrative, medical, for travel. It is composed of 16 items and an open question. | Inclusion visit 1 day | 
| Questionnaire | Positive and negative dimensions of aid The Caregiver Reaction Assessment-CRA questionnaire (Given et al., 1992) will be used to assess the positive and negative dimensions of helping. This questionnaire has 24 items. It assesses five dimensions: self-esteem, financial impact, impact on health, impact on time and lack of family support. Finally, two questions are asked to assess the reason for the assistance provided. | Inclusion visit 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic sclerosis, Relatives caregivers, Therapeutic education program