| Condition or disease |
|---|
| Fragility |
Show detailed description
| Study Type : | Observational |
| Estimated Enrollment : | 120 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Determinants of Frailty Among of Informal Caregivers of Demented Patient Evaluated in Day Care Hospital. |
| Actual Study Start Date : | February 8, 2019 |
| Estimated Primary Completion Date : | August 7, 2020 |
| Estimated Study Completion Date : | August 7, 2020 |
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Emmanuelle DURON, Md, PHd | +33144596943 | emmanuelle.duron@aphp.fr | |
| Contact: Isabelle d DUFOUR | 0185781010 | isabelle.dufour@gerondif.org |
| France | |
| Broca Hospital | Recruiting |
| Paris, Ile De Frane, France, 75016 | |
| Contact: Djamila Krabchi, Ph djamila/krabchi@aphp.fr | |
| Paul Brousse Hospital | Recruiting |
| Villejuif, Val De Marne, France, 94000 | |
| Contact: Emmanuelle Duron, Md, PHd 01 44 59 69 43 emmanuelle.duron@aphp.fr | |
| Principal Investigator: | Emmanuelle Duron, Md, PHd | APHP |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | January 22, 2019 | ||||
| First Posted Date | June 21, 2019 | ||||
| Last Update Posted Date | June 21, 2019 | ||||
| Actual Study Start Date | February 8, 2019 | ||||
| Estimated Primary Completion Date | August 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale [ Time Frame: Day 0 ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Determinants of Frailty Among of Informal Caregivers of Demented Patient | ||||
| Official Title | Determinants of Frailty Among of Informal Caregivers of Demented Patient Evaluated in Day Care Hospital. | ||||
| Brief Summary | 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. | ||||
| Detailed Description |
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 :
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
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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | caregivers of demented patients who are aware of the day care hospital and who want to be assesed | ||||
| Condition | Fragility | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
120 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | August 7, 2020 | ||||
| Estimated Primary Completion Date | August 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 65 Years and older (Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03994562 | ||||
| Other Study ID Numbers | 2018-A02925-50 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Gérond'if | ||||
| Study Sponsor | Gérond'if | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Gérond'if | ||||
| Verification Date | June 2019 | ||||