Alzheimer DiseaseACCAIDANTNCT03994237
Accompanying ALZHEIMER CAREGIVER
An observational study of Alzheimer Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Initiatives have been taken hotline in France and abroad for other conditions, they provide support to patients and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- semi-structured interview
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2018to 7 Jun 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Helping with age ≥ 18 years, speaking and understanding the French and available to accompany the patient to the consultation
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ALZHEIMER'S CAREGIVER Accompaniment
Initiatives have been taken hotline in France and abroad for other conditions, they provide support to patients and their caregivers.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- semi-structured interview
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of the grid "MiniZarit"
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.
Measured: Month 1
score of the EuroQuol scale
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)
Measured: Month 1
Secondary outcomes (3)
Number of days between pre-clinical consultation and consultation MEMORY
Impact of pre-clinical consultation on information support in consultation MEMORY
Measured: Month 3
Questionnary for caregivers' organization
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
Measured: Day 1
Questionnary for caregivers' organization
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
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start12 Dec 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle GUILLARD, Principal investigator, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994237
- Sponsor's protocol ID
- CHUBX 2016/48
- Acronym
- ACCAIDANT
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 1 Jul 2019
- 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 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALZHEIMER'S CAREGIVER Accompaniment
- ClinicalTrials.gov ID
- NCT03994237
- Acronym / sponsor ID
- ACCAIDANT / CHUBX 2016/48
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 21 Jun 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.
Initiatives have been taken hotline in France and abroad for other conditions, they provide support to patients and their caregivers.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALZHEIMER CAREGIVER | – | Other: semi-structured interviewCaregiver 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Helping with age ≥ 18 years, speaking and understanding the French and available to accompany the patient to the consultation
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| semi-structured interviewThe 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. | Other | ALZHEIMER CAREGIVER |
Primary outcome
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.
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)
3 secondary outcomes
Number of days between pre-clinical consultation and consultation MEMORY
Time frame: Month 3
Questionnary for caregivers' organization
Time frame: Day 1
Questionnary for caregivers' organization
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
Related trials for Alzheimer Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
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.
Isabelle GUILLARD principal investigator
University of Bordeaux
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 Alzheimer Disease, run by University Hospital, Bordeaux 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jul 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
score of the grid "MiniZarit" (time frame: Month 1). The study lists 2 primary outcomes in all. 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 1 Jul 2019.