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临床试验/NCT01478295
NCT01478295已完成不适用

Effectiveness of Nursing Intervention on Quality of Life of Older Caregivers: Clinical Trial Randomised by Clusters

Gerencia de Atención Primaria, Madrid2 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2013年6月1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
266
试验地点
2
主要终点
Perceived quality of life

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a structured nursing intervention (PCE), including two types of intervention defined in the literature (coping strategies promoting social support and empowerment through health education), which has an effect on the perceived quality of life for the caregiver, when compared with conventional intervention or non-support.

详细描述

Aim: to compare the effectiveness of a standardized care plan (SCP) compared to the usual nursing intervention to improve the quality of life for primary caregivers over 65 years old measured through points change with the EuroQol-5D (EQ-5D) scale.

Secondary objectives:

Evaluate the influence of prognostic variables on quality of life of caregiver. Describe the level of caregiver burden. Describe the socio-demographic profile of the dependent person and caregiver.

Method:

Design: cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. Subjects: unit of randomization: primary healthcare centres. Analysis unit: caregivers over 65 years old.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Not psychological treatment or social support during the study period.
  • Be able to follow the trial's demands.
  • Experience of caring for at least 6 months in a year.
  • Caregivers who consent to take part.

排除标准

  • Caregivers of patients hospitalized during the initial data collection.
  • Caregivers of institutionalized patients.
  • Severe psychiatric conditions including depression and major affective pictures.
  • Paid caregivers.
  • Experience as a caregiver for less than a month.

结局指标

主要结局

Perceived quality of life

时间窗: Change from baseline in quality of life at 18 months after the intervention

Perceived quality of life: Quality of life measured by EuroQol (EQ5D) Scale Change from baseline in quality of life at 18 months after the intervention

次要结局

  • Nursing diagnosis(Change from Baseline in Nursing diagnosis at 18 months after the intervention)
  • Caregiver Burden(Change from Baseline in Caregiver Burden at 18 months after the intervention)
  • Depression scale(Change from Baseline in Depression scale at 18 months after the intervention)
  • Family function(Change from Baseline in Family function at 18 months after the intervention)
  • Anxiety level(Change from Baseline in Anxiety level at 18 months after the intervention)

研究者

发起方
Gerencia de Atención Primaria, Madrid
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Milagros Rico Blazquez

Nurse

Gerencia de Atención Primaria, Madrid

研究点 (2)

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