Systemic Sclerosis' Relatives Reflex

NCT04917146 | Completed

• 1 other identifier: APHP210756
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis; Caregivers

Keywords

Systemic sclerosis; Relatives caregivers; Therapeutic education program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Questionnaire

  Inclusion visit 1 day

• Questionnaire SF36

  Inclusion visit 1 day

• Questionnaire

  Inclusion visit 1 day

• Questionnaire

  Inclusion visit 1 day

• Questionnaire

  Inclusion visit 1 day

Study Arms (1)

Caregivers (CG)

Caregivers of patients with systemic Scleroderma

Other: Self-administered questionnaires for relatives (caregivers=CG)

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.

Caregivers (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• FSMR FAI2R: collaborator
• Ministère des solidarités et de la santé: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Rhumatology Service

Paris, 75014, France

Location

Related Publications (12)

• Brignon M, Vioulac C, Boujut E, Delannoy C, Beauvais C, Kivits J, Poivret D, Giraudet Le Quintrec JS, Untas A, Rat AC. Patients and relatives coping with inflammatory arthritis: Care teamwork. Health Expect. 2020 Feb;23(1):137-147. doi: 10.1111/hex.12982. Epub 2019 Nov 27.

  PMID: 31774612 BACKGROUND

• Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

  PMID: 16731240 BACKGROUND

• Brouwer WB, van Exel NJ, van de Berg B, Dinant HJ, Koopmanschap MA, van den Bos GA. Burden of caregiving: evidence of objective burden, subjective burden, and quality of life impacts on informal caregivers of patients with rheumatoid arthritis. Arthritis Rheum. 2004 Aug 15;51(4):570-7. doi: 10.1002/art.20528.

  PMID: 15334429 BACKGROUND

• Canedo-Ayala M, Rice DB, Levis B, Carrier ME, Cumin J, Malcarne VL, Hagedoorn M, Thombs BD; Scleroderma Caregiver Advisory Committee. Factors associated with symptoms of depression among informal caregivers of people with systemic sclerosis: a cross-sectional study. Disabil Rehabil. 2020 Feb;42(3):394-399. doi: 10.1080/09638288.2018.1500647. Epub 2018 Aug 19.

  PMID: 30122129 BACKGROUND

• Given CW, Given B, Stommel M, Collins C, King S, Franklin S. The caregiver reaction assessment (CRA) for caregivers to persons with chronic physical and mental impairments. Res Nurs Health. 1992 Aug;15(4):271-83. doi: 10.1002/nur.4770150406.

  PMID: 1386680 BACKGROUND

• Jacobi CE, van den Berg B, Boshuizen HC, Rupp I, Dinant HJ, van den Bos GA. Dimension-specific burden of caregiving among partners of rheumatoid arthritis patients. Rheumatology (Oxford). 2003 Oct;42(10):1226-33. doi: 10.1093/rheumatology/keg366. Epub 2003 Jun 16.

  PMID: 12810934 BACKGROUND

• Kasle S, Wilhelm MS, Zautra AJ. Rheumatoid arthritis patients' perceptions of mutuality in conversations with spouses/partners and their links with psychological and physical health. Arthritis Rheum. 2008 Jul 15;59(7):921-8. doi: 10.1002/art.23821.

  PMID: 18576302 BACKGROUND

• Lam M, Lehman AJ, Puterman E, DeLongis A. Spouse depression and disease course among persons with rheumatoid arthritis. Arthritis Rheum. 2009 Aug 15;61(8):1011-7. doi: 10.1002/art.24510.

  PMID: 19644902 BACKGROUND

• Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.

  PMID: 9817119 BACKGROUND

• Matheson L, Harcourt D, Hewlett S. 'Your whole life, your whole world, it changes': partners' experiences of living with rheumatoid arthritis. Musculoskeletal Care. 2010 Mar;8(1):46-54. doi: 10.1002/msc.165.

  PMID: 20077577 BACKGROUND

• Rice DB, Canedo-Ayala M, Carboni-Jimenez A, Carrier ME, Cumin J, Malcarne VL, Hagedoorn M, Thombs BD; Scleroderma Caregiver Advisory Team. Challenges and support service preferences of informal caregivers of people with systemic sclerosis: a cross-sectional survey. Disabil Rehabil. 2020 Aug;42(16):2304-2310. doi: 10.1080/09638288.2018.1557268. Epub 2019 Jan 29.

  PMID: 30696293 BACKGROUND

• Untas A, Vioulac C, Boujut E, Delannoy C, Poivret D, Rat AC, Beauvais C, Giraudet Le Quintrec JS. What Is Relatives' Role in Arthritis Management? A Qualitative Study of the Perceptions of Patient-Relative Dyads. Patient Prefer Adherence. 2020 Jan 7;14:45-53. doi: 10.2147/PPA.S231919. eCollection 2020.

  PMID: 32021116 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Janine-Sophie Giraudet-Le Quintrec, MD

  Cochin Hospital - APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 8, 2021
• Study Start: June 23, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)