- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994237
Accompanying ALZHEIMER CAREGIVER (ACCAIDANT)
ALZHEIMER'S CAREGIVER Accompaniment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a descriptive pilot study, non-interventional, before / after, mono-centric, evaluative, prospective cohort with type score description. The tool used is the grid "mini Zarit", she evaluates the caregiver burden. This grid is enabled in the French version and commonly used in these pathologies.
The evaluation of the quality of life of the caregiver will be performed with the scale "EQ-5D". This tool is easy to use phone, it contains few items. Also there is very little evidence referring to the suffering or negative feelings. It therefore avoids inducing to helping unknown team consultation memory an emotionally negative discourse.
There is no validated tool measuring the service delivered to a nurse hotline. The investigators offer a nurse questionnaire 7 items grouping expectations for the first consultation memory (consultation period, diagnosis, course of the consultation, organization of monitoring). It also provides an update on the daily experiences of the caregiver relative to the organization of care and helped the organization of domestic life of helped.
Nursing questionnaire will assess whether the responses of the nurse in relation to questions about the memory request for consultation were understood in relation to the items. Also, if the caregiver is in support of application in everyday life, the questionnaire will determine if the nursing accompaniment allows the caregiver to acquire knowledge or skills, or better organization of everyday life. The question of the entourage of the caregiver assesses the isolation level of the caregiver and whether the environment is not mobilized or after an update with the nurse.
If help is hospitalized, the pattern will be recovered. The Scientific Council will assess whether the information collected and the information provided would have prevented it.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Pessac, France, 33600
- CHU de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Helping with age ≥ 18 years
- Helping speak and understand the French
- Help available to accompany the patient to the consultation
- Helping calling for the first time the memory center
- Helping who noticed a cognitive disorder in assisted
- Age over 75 years
- beneficiary or affiliated to a social security scheme Patient
- Patient with a cognitive disorder noticed by the caregiver
Exclusion Criteria:
- Helping placed under judicial protection
- Any medical or paramedical personnel in connection with the care of a nursing home eligible patient (Accommodation Establishment for dependent elderly, hospital, SSR (Care and Rehabilitation Services), institutional caregivers,
- private health professionals, such as neighborhood (doctor, nurse liberal, physiotherapist
- Neighborhood.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ALZHEIMER CAREGIVER
Caregiver available to accompany the patient to the consultation, helping calling for the first time the memory center, aidant who noticed a cognitive disorder help, having a family link identified with the patient
|
The tool used is a nurse card: there is no validated tool on the expectations of the caregiver in his memory referral.
This is a pragmatic and practical questionnaire memory consultation request and domestic life with few items, practical use by telephone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
score of the grid "MiniZarit"
Time Frame: Month 1
|
The evaluation of the quality of life of the caregiver, score between 0 and 7. point for positive response for difficulties in family life, difficulties in relationships with friends, hobbies, or in your job, a repercussion on health (physical and / or psychological), feeling that caregiver is no longer recognizing his parent, he afraid for the future of his parent, he would like to be (more) helped to take care of his parent, he feel a burden in taking care of his parent.
|
Month 1
|
score of the EuroQuol scale
Time Frame: Month 1
|
The evaluation of the quality of life of the caregiver The point repartition : Mobility (1 point : to have no problem getting around on foot ; 2 : to have problems getting around on foot; 3. to oblige to remain in bed) Self-sufficiency (1 point : to have no problem taking care of myself; 2 : to have problems washing or dressing myself alone;3 : to be unable to wash or dress myself alone) Regular activities (1 point : to have no problem performing my daily activities (eg work, study, housework, family activities or hobbies) ;2. : to have problems to perform my day-to-day activities;3. : to be unable to perform my normal activities.) Pain / discomfort (1. : to have no pain or discomfort; 2. : to have moderate pain or discomfort (s), 3. : to have severe pain or discomfort (s)) Anxiety / Depression (1. : to be not anxious or depressed; 2. : to be moderately anxious or depressed ;3. : to be extremely anxious or depressed) |
Month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days between pre-clinical consultation and consultation MEMORY
Time Frame: Month 3
|
Impact of pre-clinical consultation on information support in consultation MEMORY
|
Month 3
|
Questionnary for caregivers' organization
Time Frame: Day 1
|
Evalution of professional helpers, number of technical assistance (remote alarm ...), nature of handicap , presence of correction device, number of taking medication drugs, Sleep is good or not, recent weight evolution
|
Day 1
|
Questionnary for caregivers' organization
Time Frame: Month 1
|
Evalution of professional helpers, number of technical assistance (remote alarm ...), nature of handicap , presence of correction device, number of taking medication drugs, Sleep is good or not, recent weight evolution
|
Month 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabelle GUILLARD, University of Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2016/48
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on semi-structured interview
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Multiple Sclerosis | Parkinson Disease | Rehabilitation | Neurologic Disorder | NeurosurgeryItaly
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Hospices Civils de LyonCompleted
-
University of OxfordCompletedCeliac Disease | Mental Health Wellness 1 | Emotional Problem | Stigma, Social | Celiac Disease in Children | Celiac | DisclosureUnited Kingdom
-
University Hospital, GrenobleNot yet recruitingSchizophrenia | Schizophrenia Schizoaffective
-
The Hong Kong Polytechnic UniversityRecruitingIntensive Care Units, PediatricHong Kong
-
Fondation Hôpital Saint-JosephRecruiting
-
Universitair Ziekenhuis BrusselVrije Universiteit BrusselNot yet recruiting
-
University Hospital, MontpellierRecruiting
-
NHS Greater Glasgow and ClydeUniversity of Glasgow; The Beatson Cancer CharityRecruitingRecurrence | Lung CancerUnited Kingdom