- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03994237
Accompanying ALZHEIMER CAREGIVER (ACCAIDANT)
ALZHEIMER'S CAREGIVER Accompaniment
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Pessac, Francia, 33600
- Chu de Bordeaux
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
score of the grid "MiniZarit"
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of days between pre-clinical consultation and consultation MEMORY
Lasso di tempo: Month 3
|
Impact of pre-clinical consultation on information support in consultation MEMORY
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Month 3
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Questionnary for caregivers' organization
Lasso di tempo: Day 1
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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
|
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Questionnary for caregivers' organization
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Isabelle GUILLARD, University of Bordeaux
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUBX 2016/48
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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