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Intervention in Groups of Family Caregivers in Primary Health Care (IGFC)

VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.

Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers.

The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.

To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly face the care.

研究概览

详细说明

Methods/Design: Design: This is multicentre cross-sectional study, randomized in two parallel groups.

Setting: Two different urban PHC. Study population: 150 caregivers will be included by consecutive sampling. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Of chance form 100 caregivers will be assigned to the experimental group and 50 to the group control.

Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed.

Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.

Discussion: Psychotherapeutic interventions have been proved to obtain better results to reduce symptomatology and improve emotional state of caregivers. Moreover, this intervention has been proved to be effective in a different setting other than PHC, and was developed by professionals of Mental Health. If we found that this intervention is effective in PHC and with our professionals, it would be an important instrument to offer to caregivers of care-dependent patients.

研究类型

介入性

注册 (预期的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Salamanca.、西班牙、37003
        • Primary care Research unit. La Alamedilla health centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers

Exclusion Criteria:

  • Those persons who did not share their place of residence with the relative, or who were impossible to locate either due to a change of address or being admitted to hospital or a nursing home, or on account of the patient's death were excluded

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:控制
实验性的:psychotherapy

The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health of caregivers.

This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.

A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
其他名称:
  • Received usual care.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in caregivers will be the principal measure:
大体时间:Initial and 6 months later
family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring.
Initial and 6 months later

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rodriguez-Sanchez Emiliano, MD、La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
  • 学习椅:Mora-Simón Sara、La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
  • 学习椅:Porras-Santos Nieves、La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.
  • 学习椅:Patino-Alonso M. Carmen, MD、Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain.
  • 学习椅:Recio-Rodríguez José-Ignacio、La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • 学习椅:Becerro-Muñoz Concepción, MD、La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • 学习椅:Pérez-Arachaederra Diana、La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • 学习椅:Gómez-Marcos Manuel-Ángel, md、La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
  • 研究主任:García Ortiz Luís, MD、La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年9月1日

初级完成 (预期的)

2009年6月1日

研究完成 (预期的)

2010年9月1日

研究注册日期

首次提交

2010年7月30日

首先提交符合 QC 标准的

2010年8月5日

首次发布 (估计)

2010年8月9日

研究记录更新

最后更新发布 (估计)

2010年8月9日

上次提交的符合 QC 标准的更新

2010年8月5日

最后验证

2010年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GRS270A08

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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