跳至主要内容
临床试验/NCT03475576
NCT03475576已完成不适用

Together in Line, the Power of Informal Care in Group

KU Leuven2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年3月28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
KU Leuven
入组人数
64
试验地点
2
主要终点
depressive complaints

研究概览

简要总结

An aging population means an increase of the oldest part of the population, resulting from a change in demographic behavior and an increasing lifespan. The social networks are changing and the health care costs are rising. We know informal care of older civilians becomes more and more complex. A formal framework with a good communication to support informal caregivers is therefore essential in order to provide good care for a dependent older civilian.

Informal care is the support and assistance of a dependent person, outside the context of professional care or organized volunteering, but by one or more members from the immediate vicinity of the dependent1. The 'informal care group' is defined as follows: 'a group of two or more persons who together provide informal care to a dependent person, beyond the scope of professional care or organized volunteering, but as members of the immediate vicinity of the dependent'.

In this group, the different members contribute to the care process in an equitable but non-proportional manner. The dynamics in an informal care group are obviously different from those in a family where one central informal caregiver is responsible for the care of the ill relative: behind each individual of the informal care group, there is also a partner and/or children who influence the care motivations and accountability.

Sharing informal caregiving has important advantages. Firstly, individuals of the informal care group needs less time to fulfill specific caregiver tasks and have more time to cope with external stressors. Secondly, caregivers in group receive support from each other, which strengthens their self-efficacy. However, the involvement of more caregivers may also be a source of conflict.

This project aims to meet the needs of informal care groups of older civilians. An adjusted support for older civilians (≥70 years) and their informal care group will be achieved. We will focus on their needs, aimed to decrease the caregiver burden and increase the well-being of both older civilian and caregivers. This goal will be achieved by a better care planning and attempts to improve communication between older civilian, informal and professional caregivers, which we found in previous research as difficult and an important obstacle in concretize individual tailored support of the older civilian and caregivers.

详细描述

  1. Study design The study has a before-and-after study design, the tailored support will be available for every informal care group and no older civilian will be excluded from an optimal care context, which is required by the social framework of this project. Therefore, no control group will be included in this study. The intervention consists of already existing support, although it is strengthened by means of a self-management tool, the 'Keuzewijzer', which helps the informal care group making specific choices with regard to tailored support, adjusted to their needs, norms and values. By a pre- and post-test, the effect of the intervention on the psychosocial well-being of the informal caregivers can be mapped out.
  2. Study population 2.1. Study population definition In this study, informal care groups of older civilians will be included. These civilians will be 70 years or older and have to live independently at home in the Leuven region. The informal care groups consist of two or more relatives, friends or neighbors caring for the older civilian (≥70 years), beyond the scope of professional care or organized volunteering. There are no age restriction for the informal caregivers.

2.2. Inclusion and exclusion criteria Both the older civilians and the informal caregiver give their written consent after being informed. Only civilians aged 70 years or older and their informal caregivers who have a thorough command of Dutch will be included. Older civilians with a formal diagnosis of dementia, too ill to participate or in a palliative phase be excluded. 3. Intervention The intervention, offered to the older civilians and their informal care groups will consist of an updated version of the 'Keuzewijzer', which has been developed in an earlier phase of the research project. This is a self-management tool which stimulates the communication within the informal care groups to make behaved choices concerning the care for the older civilian, taking into account the standards, values, concerns and needs of every informal caregiver and older civilian.

The following aspects will be discussed in the context of the care for the older civilian: 1) analyzing the problem, 2) detection of possibilities or alternatives, 3) clarifying of motives and feelings and 4) weighting between values. The first purpose of this intervention is to develop a care planning focused on the older civilians with a clear distribution of tasks. The second purpose is to stimulate the communication between the informal caregivers and the older civilian, allowing timely adjustments in the care planning and preventing for caregiver burden.

The intervention consist of the following parts: 1) introduction conversation, 2) Keuzewijzer and 3) follow-up conversation. In addition, an evaluation of the intervention takes place at the end of the intervention study (6 months).

3.1. Introduction conversation During this conversation, a researcher will explain the dual purpose of the study, in which on the one hand the psychosocial well-being of the informal caregivers and the older civilian is mapped by means of the personal interviews and on the other hand, tailored support is offered through the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Both the older civilians and the informal caregiver give their written consent after being informed.
  • Only civilians aged 70 years or older and their informal caregivers will be included.
  • Only civilians and their informal caregivers who have a thorough command of Dutch will be included.

排除标准

  • Older civilians with a formal diagnosis of dementia
  • too ill to participate
  • in a palliative phase

结局指标

主要结局

depressive complaints

时间窗: 6 months

Geriatric Depression Scale: The most commonly used scale for late-life depression is the geriatric depression scale (GDS). The GDS is an instrument to measure depressive complaints specifically in an older population. However, Covinsky et al. has also used it to screen for caregiver depression. The short version will be used, which consists of 15 yes or no questions. The scores are summed range 0-15 and the participant is categorised as having depressive complaints when he or she scores five or higher. The 15-item GDS has been shown to have adequate sensitivity and specificity and to be significantly more accurate than the 30-item GDS.

caregiver burden

时间窗: 6 months

The Zarit burden interview (ZBI), a self-report scale, is believed to be the most commonly used measure of caregiver burden. Initially the ZBI was developed to measure strain associated with the care of community-dwelling persons with Alzheimer disease, but Bachner et al. showed that the ZBI was reliable across populations of caregivers and patients. The ZBI was used to assess the subjective burden experienced by an informal caregiver. For this study an adjusted 12 item ZBI, derived from the QUALIDEM Project, was chosen. The answers are never, rarely, sometimes, quite frequently and nearly always (scored from 0 to 4). The sum was taken over all the questions (range 0-48) and the caregiver was assigned to a category of severe or high burden if the score was 17 or higher. The standard ZBI-12 of Bedard et al. has shown a high correlation with the full ZBI ranging from 0.92 to 0.97 (p=0.001).

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Birgitte Schoenmakers

Professor Dr.

KU Leuven

研究点 (2)

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