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Pilot Study of the Impact of Giant Cell Arteritis and Its Treatment on the Autonomy of the Elderly in the First Year of Care (EPACAPA)

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ClinicalTrials.gov Identifier: NCT03961113
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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Brief Summary:
Giant cell arteritis is the leading cause of vasculitis in the elderly. No work evaluates its impact on autonomy. At the diagnosis a gerontological evaluation will be carried out including the scores ADL, iADL, MNA, SF 36, SPPB, FRIED and GDS. A monthly telephone reassessment will collect ADL and iADL. The end-of-study consultation at M12, conducted by a geriatrician, will have the same scores as at M0. This will make it possible to evaluate the difference in the functional autonomy score between M0 and M12 in the elderly with ACG.

Condition or disease Intervention/treatment
Giant Cell Arteritis in Dependency of Elderly Other: Assessment by questionnaire

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the Impact of Giant Cell Arteritis and Its Treatment on the Autonomy of the Elderly in the First Year of Care
Actual Study Start Date : May 17, 2019
Estimated Primary Completion Date : May 17, 2023
Estimated Study Completion Date : May 17, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
assessment by questionnaire Other: Assessment by questionnaire

At diagnosis a gerontological evaluation will be carried out including the following tests: ADL, iADL, MNA, SF 36, SPPB, FRIED criteria and GDS. The set of scales and scores of the procedure is commonly used in geriatrics to assess the fragility of the patient.

A monthly telephone reassessment conducted by an ARC will collect ADL and iADL from the first month to the eleventh month. The end-of-study consultation will be conducted by a geriatrician at the 12th month and will include the following tests: ADL, iADL, MNA, SF 36, the SPPB, the criteria of FRIED and the GDS


Outcome Measures
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Primary Outcome Measures :
  1. Activities of Daily Living (ADL) [ Time Frame: Month 12 ]
    Compare score between Month 0 and Month 12. The scale is evaluated from 0 (dependence) to 6 (autonomy).


Secondary Outcome Measures :
  1. Activities of Daily Living (ADL) [ Time Frame: Month 11 ]
    Compare the evolution every month at M0 and every month up to Month 11 The scale is evaluated from 0 (dependence) to 6 (autonomy).


Other Outcome Measures:
  1. Instrumental Activities of Daily Living (iADL) [ Time Frame: Month 12 ]
    Compare the evolution every month at Month 0 and every month up to Month 12 The scale is evaluated from 0 (dependence) to 8 (autonomy).

  2. Mini Nutritional Assessment (MNA) [ Time Frame: Month 12 ]
    Compare score between Month 0 and Month 12 The scale is evaluated from 0 (poor nutritional status) to 30 (correct)

  3. The Short Form Health Survey (SF-36) : Physical score [ Time Frame: Month 12 ]
    Compare score between Month 0 and Month 12 The scale is evaluated from 13,6 (poor physical condition) to 61.9 (good physical condition)

  4. The Short Form Health Survey (SF-36) : Psychic score [ Time Frame: Month 12 ]
    Compare score between Month 0 and Month 12 The scale is evaluated from 15.6 (poor psychic condition) to 70 (good physical condition)

  5. Short Physical Performans Battery (SPPB) [ Time Frame: Month 12 ]
    compare score between Month 0 and Month 12 The scale is evaluated from 0 (poor performance) to 12 (high performance)

  6. fragility criteria questionnaire (Fried) [ Time Frame: Month 12 ]
    compare score between Month 0 and Month 12 The scale is evaluated from 0 (robust) to 5 (fragile)

  7. Geriatric Depression Scale (GDS) [ Time Frame: Month 12 ]
    compare score between Month 0 and Month 12 The scale is evaluated from 0 (normal) to 30 (severe depression)

  8. The cumulative dose of corticosteroids and autonony loss [ Time Frame: Month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with giant cell arteritis
Criteria

Inclusion Criteria:

  • Age greater than or equal to 65 years with at least 2 comorbidities * present, or age greater than or equal to 75 years

  • Diagnosis of ACG meeting the diagnostic criteria of ACG 1990 ACR

    • comorbidity = chronic pathology

Exclusion Criteria:

  • Neoplastic pathology under treatment
  • Brain pathology with motor disability
  • Dementia at a severe stage (MMS <22/30)
  • Unable to answer the phone
  • Participation in a therapeutic clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961113


Contacts
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Contact: Anne Laure FAUCHAIS, PU PH + 33 555 058 076 anne-laure.fauchais@chu-limoges.fr

Locations
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France
University Hospital Recruiting
Limoges, France, 87042
Contact: Anne Laure FAUCHAIS, PU PH    + 33 555 058 076    anne-laure.fauchais@chu-limoges.fr   
Sponsors and Collaborators
University Hospital, Limoges
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03961113    
Other Study ID Numbers: 87RI18_0008 (EPACAPA)
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Giant Cell Arteritis
Dependency
Elderly
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases