Giant Cell Arteritis in Dependency of ElderlyEPACAPANCT03961113
Pilot Study of the Impact of Giant Cell Arteritis and Its Treatment on the Autonomy of the Elderly in the First Year of Care
An observational study of Giant Cell Arteritis in Dependency of Elderly, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Giant Cell Arteritis in Dependency of Elderly
- What is being tested?
- Assessment by questionnaire
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2019to 21 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patient with giant cell arteritis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Assessment by questionnaire
- Keywords
- Giant Cell Arteritis, Dependency, Elderly
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment by questionnaireOther
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 group | Role | What they receive |
|---|---|---|
| assessment by questionnaire | Not described Receives: Other: Assessment by questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of Daily Living (ADL)
Compare score between Month 0 and Month 12. The scale is evaluated from 0 (dependence) to 6 (autonomy).
Measured: Month 12
Secondary outcomes (1)
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).
Measured: Month 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start17 May 2019
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Why it stopped: inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis in Dependency of ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961113
- Sponsor's protocol ID
- 87RI18_0008 (EPACAPA)
- Acronym
- EPACAPA
- Status last verified
- Jul 2022
- First submitted
- 17 May 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03961113
- Acronym / sponsor ID
- EPACAPA / 87RI18_0008 (EPACAPA)
- Keywords
- Giant Cell Arteritis, Dependency, Elderly
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inadequate recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment by questionnaire | – | Other: Assessment by questionnaire |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patient with giant cell arteritis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment by questionnaireAt 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 | Other | assessment by questionnaire |
Primary outcome
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).
1 secondary outcome
Activities of Daily Living (ADL)
Time frame: Month 11
Results and safety
The study was stopped early (reason given: inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis in Dependency of Elderly, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inadequate recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of Daily Living (ADL) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.