Giant Cell Arteritis in Dependency of Elderly Clinical Trial
— EPACAPAOfficial 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
| Verified date | July 2022 |
| Source | University Hospital, Limoges |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | June 21, 2022 |
| Est. primary completion date | June 21, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital | Limoges |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Limoges |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | 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 | |
| Other | fragility criteria questionnaire (Fried) | compare score between Month 0 and Month 12 The scale is evaluated from 0 (robust) to 5 (fragile) | Month 12 | |
| Other | 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 | |
| Other | The cumulative dose of corticosteroids and autonony loss | Month 12 | ||
| Primary | 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 | 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 |