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出境医 / 临床实验 / 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)
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)
Study Description
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
| 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 |
Arms 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 |
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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:
- 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).
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- The cumulative dose of corticosteroids and autonony loss [ Time Frame: Month 12 ]
Eligibility Criteria
| 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
Contacts
| Contact: Anne Laure FAUCHAIS, PU PH | + 33 555 058 076 | anne-laure.fauchais@chu-limoges.fr |
Locations
| 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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 17, 2019 | ||||
| First Posted Date | May 23, 2019 | ||||
| Last Update Posted Date | March 17, 2021 | ||||
| Actual Study Start Date | May 17, 2019 | ||||
| Estimated Primary Completion Date | May 17, 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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).
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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).
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
|
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief 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 | ||||
| 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 | ||||
| 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 Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | patient with giant cell arteritis | ||||
| Condition | Giant Cell Arteritis in Dependency of Elderly | ||||
| Intervention | 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 |
||||
| Study Groups/Cohorts | assessment by questionnaire
Intervention: Other: Assessment by questionnaire
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
50 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | May 17, 2023 | ||||
| Estimated Primary Completion Date | May 17, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 65 Years and older (Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03961113 | ||||
| Other Study ID Numbers | 87RI18_0008 (EPACAPA) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | University Hospital, Limoges | ||||
| Study Sponsor | University Hospital, Limoges | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University Hospital, Limoges | ||||
| Verification Date | March 2021 | ||||
