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)

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.

Study Overview

• Status: Terminated
• Conditions: Giant Cell Arteritis in Dependency of Elderly
• Intervention / Treatment: Other: Assessment by questionnaire

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patient with giant cell arteritis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities of Daily Living (ADL)	Compare score between Month 0 and Month 12. The scale is evaluated from 0 (dependence) to 6 (autonomy).	Month 12

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instrumental Activities of Daily Living (iADL)	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).	Month 12
Mini Nutritional Assessment (MNA)	Compare score between Month 0 and Month 12 The scale is evaluated from 0 (poor nutritional status) to 30 (correct)	Month 12
The Short Form Health Survey (SF-36) : Physical score	Compare score between Month 0 and Month 12 The scale is evaluated from 13,6 (poor physical condition) to 61.9 (good physical condition)	Month 12
The Short Form Health Survey (SF-36) : Psychic score	Compare score between Month 0 and Month 12 The scale is evaluated from 15.6 (poor psychic condition) to 70 (good physical condition)	Month 12
Short Physical Performans Battery (SPPB)	compare score between Month 0 and Month 12 The scale is evaluated from 0 (poor performance) to 12 (high performance)	Month 12
fragility criteria questionnaire (Fried)	compare score between Month 0 and Month 12 The scale is evaluated from 0 (robust) to 5 (fragile)	Month 12
Geriatric Depression Scale (GDS)	compare score between Month 0 and Month 12 The scale is evaluated from 0 (normal) to 30 (severe depression)	Month 12
The cumulative dose of corticosteroids and autonony loss		Month 12

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2019
• Primary Completion (ACTUAL): June 21, 2022
• Study Completion (ACTUAL): June 21, 2022

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (ACTUAL): May 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Elderly; Giant Cell Arteritis; Dependency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: 87RI18_0008 (EPACAPA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No