Systemic SclerosisRelativReflexNCT04917146
Systemic Sclerosis' Relatives Reflex
An observational study of Systemic Sclerosis and Caregivers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Caregivers
- What is being tested?
- Self-administered questionnaires for relatives (caregivers=CG)
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2021to 23 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 .
Who may be able to join
- 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.
Who cannot join
- Inability to answer questionnaires (language, cognitive disorders, etc.).
- under curatorship or tutorship
- with State medical care (AME)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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...)
- Conditions
- Systemic Sclerosis, Caregivers
- Being tested
- Self-administered questionnaires for relatives (caregivers=CG)
- Keywords
- Systemic sclerosis, Relatives caregivers, Therapeutic education program
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers (CG) | Caregivers of patients with systemic Scleroderma Receives: Other: Self-administered questionnaires for relatives (caregivers=CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Inclusion visit 1 day
Secondary outcomes (5)
Questionnaire
Socio-demographic information about the caregiver Sociodemographic information will be collected on the informal caregiver: age, sex, professional situation, seniority of the help.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Inclusion visit 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start23 Jun 2021
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- FSMR FAI2R, Ministère des solidarités et de la santé, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Janine-Sophie Giraudet-Le Quintrec, MD, Principal investigator, Cochin Hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917146
- Sponsor's protocol ID
- APHP210756
- Acronym
- RelativReflex
- Status last verified
- Oct 2025
- First submitted
- 27 May 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31774612Broadbent 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.
PubMed 16731240Brouwer 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.
PubMed 15334429Canedo-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.
PubMed 30122129Given 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.
PubMed 1386680Jacobi 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.
PubMed 12810934Kasle 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.
PubMed 18576302Lam 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.
PubMed 19644902Leplege 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.
PubMed 9817119Matheson 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.
PubMed 20077577Rice 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.
PubMed 30696293Untas 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.
PubMed 32021116
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04917146
- Acronym / sponsor ID
- RelativReflex / APHP210756
- Conditions
- Systemic Sclerosis, Caregivers
- Keywords
- Systemic sclerosis, Relatives caregivers, Therapeutic education program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- FSMR FAI2R, Ministère des solidarités et de la santé, URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers (CG) | – | Other: Self-administered questionnaires for relatives (caregivers=CG)Caregivers of patients with systemic Scleroderma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to answer questionnaires (language, cognitive disorders, etc.).
- under curatorship or tutorship
- with State medical care (AME)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered questionnaires for relatives (caregivers=CG)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. | Other | Caregivers (CG) |
Primary outcome
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.
5 secondary outcomes
Questionnaire
Time frame: Inclusion visit 1 day
Questionnaire SF36
Time frame: Inclusion visit 1 day
Questionnaire
Time frame: Inclusion visit 1 day
Questionnaire
Time frame: Inclusion visit 1 day
Questionnaire
Time frame: Inclusion visit 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 31774612Brignon 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.
- Background: PubMed 16731240Broadbent 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.
- Background: PubMed 15334429Brouwer 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.
- Background: PubMed 30122129Canedo-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.
- Background: PubMed 1386680Given 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.
- Background: PubMed 12810934Jacobi 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.
- Background: PubMed 18576302Kasle 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.
- Background: PubMed 19644902Lam 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.
- Background: PubMed 9817119Leplege 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.
- Background: PubMed 20077577Matheson 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.
- Background: PubMed 30696293Rice 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.
- Background: PubMed 32021116Untas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janine-Sophie Giraudet-Le Quintrec, MD principal investigator
Cochin Hospital - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Caregivers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: Inclusion visit 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917146, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.