CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Self-administered questionnaires for relatives (caregivers=CG)other
Likely dose
Not stated in record
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Search/NCT04917146
NCT04917146N/ACompleted

"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

Assistance Publique - Hôpitaux de Paris·observational·Posted Jun 8, 2021·Updated Nov 20, 2025

In Brief

An observational study evaluating Self-administered questionnaires for relatives (caregivers=CG) for Systemic Sclerosis and Caregivers. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 8, 2021
Enrollment StartJun 23, 2021
Primary CompletionJun 23, 2022
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 5.1 years ago

Interventions

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.