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Completed

NCT Number: NCT04917146

Systemic Sclerosis' Relatives Reflex

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.

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Key information

Conditions

Systemic Sclerosis Caregivers Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rhumatology Service

Paris, 75014, France

About this study

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...)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Self-administered questionnaires for relatives (caregivers=CG)

Other

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.

Primary outcomes

  1. Questionnaire

    Time frame: Inclusion visit 1 day

    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.

Secondary outcomes

  1. Questionnaire

    Time frame: Inclusion visit 1 day

    Socio-demographic information about the caregiver Sociodemographic information will be collected on the informal caregiver: age, sex, professional situation, seniority of the help.

  2. Questionnaire SF36

    Time frame: Inclusion visit 1 day

    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.

  3. Questionnaire

    Time frame: Inclusion visit 1 day

    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.

  4. Questionnaire

    Time frame: Inclusion visit 1 day

    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.

  5. Questionnaire

    Time frame: Inclusion visit 1 day

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • FSMR FAI2R
  • Ministère des solidarités et de la santé
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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

Acronym: RelativReflex

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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