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临床试验/NCT03992040
NCT03992040已完成不适用

Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD)Device

Gérond'if1 个研究点 分布在 1 个国家目标入组 677 人开始时间: 2019年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
677
试验地点
1
主要终点
Assessment of hospitalization frequency for patients with Reinforced SSIAD compared to similar patients in classic SSIAD.

研究概览

简要总结

The main purpose is to study, in comparison to classic Home Nursing Care Services (SSIAD), the effect of reinforced Home Nursing Care Services (SSIAD) on the occurrence of hospitalizations

详细描述

It's a non-interventional, multi-centred, controlled study.

Inclusions will start with patients benefit from a so-called "reinforced" bed in the experimental Home Nursing Care Services (SSIAD), that is, with a score between 11 and 21 on the regional public health authorities (ARS) score. Patients from the classic Home Nursing Care Services SSIAD (control arm) will be inclused on a matching mode to the individual clinical profiles of patients recruited into the reinforced Home Nursing Care Services (SSIAD). Matching will be based on age, sex, and comorbidity score (Charlson scale). Screening for matching will be done by a geriatric physician appointed by the sponsor. Once screened in, patients will be proposed the study by the Home Nursing Care Services SSIAD lead investigator who provides home care. Patients in the control arm will also express no opposition. For each patient accepting the study, their family caregiver - if there is one - will also be proposed the study. Various data: Prescription medicinal, reason and duration of hospitalization, number and reason for emergency department presentations, independence and dependency scores and other scales will be collected retrospectively, at inlcusion (J0) , then monthly (M1 to M12).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 60 years old
  • Having obtained a place in SSIAD by medical prescription
  • Able to understand and respond to study questionnaires and evaluations with or without the Assistance of a third party
  • Resident in territories of activities of the SSIAD participating in assessment
  • With social coverage
  • Having expressed non-oppostion to his participation in study and documented in his medical file
  • Only for patients in " einforced SSIAD ": patient with a so-called "reinforced" bed financed by " Regional Public Health authorities " (ARS) of Ile-de-France, and with a score between 11 and 21 on the ARS score

排除标准

  • Age < 60 years old
  • Expressing his opposition to participate in the study
  • Not resident in the territory of activity of SSIAD
  • Requires only technical care and management in the act
  • Unable to understand and respond to study questionnaires and evaluations, even with third party assistance

结局指标

主要结局

Assessment of hospitalization frequency for patients with Reinforced SSIAD compared to similar patients in classic SSIAD.

时间窗: 12 months

Assess the hospitalization frequency for patients with an enhanced SSIAD placement compared to similar patients in conventional SSIAD.

次要结局

  • Assessment of teh degree of autonomy according AGGIR score(12 months)
  • Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)(12 months)
  • Assessment of commorbidity risk according Charlson score(12 months)
  • Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale(12 months)
  • Assessment of quality of life according "Nottingham health profile" scale(12 months)
  • Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale(12 months)
  • Assessment of qualityof life for caregiver according "36-Item Short Form Survey" (SF-36) Score(12 months)
  • Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale(12 months)

研究者

发起方
Gérond'if
申办方类型
Other
责任方
Sponsor

研究点 (1)

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