- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03994562
Bestämningsfaktorer för svaghet bland informella vårdgivare för dementa patienter (DELFAF)
Bestämningsfaktorer för svaghet bland informella vårdgivare för dementa patienter som utvärderas på dagvårdssjukhus.
Frailty, a transitional state between successful and pathological aging, may be benefit from early multi-interventional intervention. Fried's criteria are the more commonly used criteria to diagnose frailty. The caregivers' burden increases caregivers' morbidity .The main objective of the study was to assess the relationship between frailty among informal caregivers of demented patients and the caregiver's burden (Zarit scale). The Secondary objective was to assess determinants of frailty among caregivers.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Frailty, a transitional state between successful and pathological aging, may be benefit from early multi-interventional intervention.
Fried's criteria are the more commonly used criteria to diagnose frailty :
- Loss of weight > 4.5 kg over one year,
- Self-reported exhaustion,
- Low muscle strength (handgrip <20% norm for age and sex),
- Low physical activity
- Low gait speed (<0.8m/s). According to the number of Fried's criteria, subjects are considered frail (≥ 3 Fried's criteria), pre-frail (1-2 Fried's criteria) or robust (0 Fried's criterion).
A large proportion of care is believed to be delivered by informal caregivers (e.g., spouses, next of kin). The caregivers' burden experienced as "enduring stress and frustration" due to caregiving, affects caregivers' mental health with depression, anxiety and sleep disorders, increases caregivers' morbidity and mortality. Multi-interventional studies (including physical and psychological wellbeing) have proven their accuracy to improve quality of life of caregivers.
In France, caregivers (>60 years) of demented people number have been estimate to 3.3 million (DREES).
For more than one year, in the Broca memory center (3000 patients/ years), caregivers can benefit from a comprehensive medico-psychosocial assessment during a day care hospital. Frailty is assessed in usual care. Two caregivers a week benefit from this assessment. The same day care hospital has been implemented in the "Paul Brousse" hospital (100 patients/year) : One caregiver a week benefit from this assessment.
Main objective:
To assess the relationship between frailty among informal caregivers of demented patients and the caregiver's burden (Zarit scale).
Secondary objective:
To assess determinants of frailty among caregivers.
Main outcome :
Caregiver burden will be determined according to the Zarit scale. The Zarit scale is an auto-questionnaire which includes 22 questions (rated from 0 to 4 points) and scores out of 88. A higher score reflects a higher caregiver burden.
Frailty will be defined by Fried criteria. Subjects will be considered as frail (≥ 3 Fried's criteria), pre-frail (1-2 Fried's criteria) or robust (0 Fried's criteria).
Secondary outcomes
- Age, sex, educational level
- Treatments et polypharmacy (≥ 4 treatments)
- Neuropsychological test if cognitive complaint : caregivers will be categorized as cognitively normal, mild cognitive impairment or dementia.
- Depression according to the Pichot scale and the Geriatric Depression Scale.
- Anxiety according to the Goldberg scale
- Nutritional Assessment: mini nutritional assessment and body mass index.
Feasibility :
Eighty caregivers will be included in the Broca hospital and 40 in the Paul Brousse hospital. To reach the calculated number of subjects to include (n=120), inclusions will take place during 1 year and a half.
Statistical analysis
Main objective :
To disclose a difference in the Zarit score of 11 points (retrospective analysis of collected data) with 80% power and α 5% risk, 120 subjects have to be included. The population will be described and factors associated with the Zarit scale in uni-variate analysis will be studied in a multiple linear regression model.
Analysis will be also performed according to 3 groups: frail, pre-frail and robust.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Ile de Frane
-
Paris, Ile de Frane, Frankrike, 75016
- Broca Hospital
-
-
Val de Marne
-
Villejuif, Val de Marne, Frankrike, 94000
- Paul Brousse Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
caregivers of demented patients who are aware of the day care hospital and who want to be assesed
Beskrivning
Inclusion Criteria:
- caregivers of demented patients ,
- over > 65 years old,
- who accept exhaustive evalutaion in day care hospital, who agree for ther data to be recorded (anonymously) for an observational study
Exclusion Criteria:
- No affliation to French social insurance system
- People under tutorship
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Bedömning av den emotionella, fysiska och ekonomiska bördan på en vårdgivare enligt Zarits bördaskala
Tidsram: Dag 0
|
Dag 0
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Mätning av kognitiv funktionsnedsättning enligt Mini-Mental State Examination (MMSE) poäng
Tidsram: Dag 0
|
Dag 0
|
|
Screening för en näringsstörning enligt Body Mass Index (BMI) poäng
Tidsram: Dag 0
|
Dag 0
|
|
Bedömning av verbalt episodiskt minne enligt Grober och Buschkes test
Tidsram: Dag 0
|
Dag 0
|
|
Screening av undernäringen enligt mininäringsbedömning (MNA)
Tidsram: Dag 0
|
Dag 0
|
|
Bedömning av ångest enligt Goldberg-skalan
Tidsram: Dag 0
|
Dag 0
|
|
Bedömning av humor i geriatrik enligt Geriatric Depression Scale (GDS)
Tidsram: Dag 0
|
Dag 0
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Emmanuelle Duron, Md, PHd, APHP
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018-A02925-50
Plan för individuella deltagardata (IPD)
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