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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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03961113
Acronym
EPACAPA
Enrollment
10
Registered
2019-05-23
Start date
2019-05-17
Completion date
2022-06-21
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis in Dependency of Elderly

Keywords

Giant Cell Arteritis, Dependency, Elderly

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.

Interventions

OTHERAssessment 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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Other

MeasureTime frameDescription
The Short Form Health Survey (SF-36) : Physical scoreMonth 12Compare score between Month 0 and Month 12 The scale is evaluated from 13,6 (poor physical condition) to 61.9 (good physical condition)
The Short Form Health Survey (SF-36) : Psychic scoreMonth 12Compare score between Month 0 and Month 12 The scale is evaluated from 15.6 (poor psychic condition) to 70 (good physical condition)
Short Physical Performans Battery (SPPB)Month 12compare score between Month 0 and Month 12 The scale is evaluated from 0 (poor performance) to 12 (high performance)
Instrumental Activities of Daily Living (iADL)Month 12Compare the evolution every month at Month 0 and every month up to Month 12 The scale is evaluated from 0 (dependence) to 8 (autonomy).
Geriatric Depression Scale (GDS)Month 12compare score between Month 0 and Month 12 The scale is evaluated from 0 (normal) to 30 (severe depression)
The cumulative dose of corticosteroids and autonony lossMonth 12
fragility criteria questionnaire (Fried)Month 12compare score between Month 0 and Month 12 The scale is evaluated from 0 (robust) to 5 (fragile)
Mini Nutritional Assessment (MNA)Month 12Compare score between Month 0 and Month 12 The scale is evaluated from 0 (poor nutritional status) to 30 (correct)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026