- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02351453
Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)
연구 개요
상태
정황
상세 설명
In order to reduce Alzheimer Disease (AD) adverse impacts at individual level as well as in terms of expenditures, the development of efficient strategies based on the identification and the correction of risk factors of institutionalization of AD patients proves necessary.
While it has been identified that institutionalization date depends on patients' health characteristics, the role of social, economic and environmental factors still remains few known.
The investigators hypothesized that institutionalization of AD patients could be related not only to medico-neuropsychological patients' characteristics but also to socio-economic and environmental characteristics of dyad (i.e., AD patient and spouse carer), that could modify the delay of institutionalization.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Angers, 프랑스, 49933
- University Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Eligibility criteria for AD patients were:
- Over age 65,
- Diagnosis of AD according to the NINCDS-ADRDA ( National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria,
- Last memory center consultation between 6 and 12 months before the inclusion,
- Being affiliated to the French health insurance,
- Living at home,
- Having a caregiver with inclusion criteria,
- Agreement of General Practitioner (GP) of AD patient to participate in the study and affiliation of the GP to the national "Association pour le Développement de l'Information Médicalisée" (ADIM) French network.
Eligibility criteria for spouse carers were:
- Over age 65,
- Being the spouse and the caregiver of AD patient,
- Being affiliated to the French health insurance,
- Living at home with AD patient.
Exclusion Criteria:
Non inclusion criteria for AD patients and spouse carers were:
- An inability to understand and speak French,
- Acute disease in the past month of baseline assessment,
- Expected moving outside the recruitment area during the follow-up period
- Concomitant participation in a clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Date of institutionalization of AD patients (standardized questionnaire)
기간: This outcome is assessed at 12 months.
|
Date of entrance in institution was collected by a standardized questionnaire.
|
This outcome is assessed at 12 months.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The increase formal home help services (measured by a standardized questionnaire and coded as a binary variable)
기간: This outcome is assessed at baseline and 12 months.
|
The use of formal home help services was measured by a standardized questionnaire and coded as a binary variable.
|
This outcome is assessed at baseline and 12 months.
|
|
The delay of institutionalization of AD patients (assessed by a standardized questionnaire and expressed in number of days)
기간: This outcome is assessed at baseline and 12 months.
|
The delay of institutionalization was assessed by a standardized questionnaire and expressed in number of days.
|
This outcome is assessed at baseline and 12 months.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Olivier Beauchet, MD, PhD, University Hospital, Angers
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .