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

Terminated

• Conditions: Giant Cell Arteritis in Dependency of Elderly
• Interventions: Other: Assessment by questionnaire

• Registration Number: NCT03961113
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-17
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
assessment by questionnaire	Assessment by questionnaire	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Activities of Daily Living (ADL)	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).

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Limoges, France