跳至主要内容
临床试验/NCT05487482
NCT05487482Unknown不适用

Development of the Ageing Safety From the Risk (ASRi) Model for Safety Culture by Empowering the Family at Home: a Mixed-methods Study Protocol

Gadjah Mada University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2021年7月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
136
试验地点
1
主要终点
Incidence of adverse events

研究概览

简要总结

Background: The elderly are a vulnerable group for health problems as they age. Safe care is essential when caring for the elderly at home because adverse events can happen there, such as falls, pressure ulcers, injuries, or dangers caused by medication errors. Safety culture for the elderly at home needs to be developed so that they can avoid unexpected events. This study aimed to develop the model for safety culture among the elderly called Aging Safe from the Risk (ASRi) to improve the safety culture in elderly care at home.

Methods: This exploratory sequential mixed methods study will consist of three stages. Stage 1, a qualitative descriptive study, will be conducted to explore the perceptions of families, nurses, and school administrators for the elderly regarding the safety of the elderly at home. Data will be collected by interviews and focus group discussions. Stage II will involve developing The ASRi model using the modified Delphi method. The list of elderly safety culture indicators will be assessed by experts and then further developed into a model. In stage III, a model test will be conducted with a non-equivalent control group using a quasi-experimental design. The investigators will provide interventions in the form of education and training to families regarding the safety culture for the elderly at home.

Findings: There is a crucial need for studies assessing the safety culture in elderly care by empowering families at home to improve safety for the elderly. The results of this study will help fill the knowledge gap in this research and can aid in developing public health policy and programs for the elderly.

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详细描述

This study aims to obtain a model of elderly safety culture by involving families in self-care at home to increase perceptions of safety culture and reduce adverse events at home. The specific aims are:

  1. Exploring the perceptions of families, healthcare providers, and elderly school administrators regarding the safety of the elderly at home;
  2. Develop the Ageing Safe from the Risk (ASRi) model of safety culture; and
  3. Conducting trials of applying the ASRi model to improve the perception of the elderly safety culture and reduce adverse events at home.

This protocol have been approval from the Medical and Health Research Ethics Committee of the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada-Dr. Sardjito General Hospital with the number KE/FK/0632/EC/2021 on the date in 10 June 2021.

Study design This exploratory sequential mixed methods will include three stages, and the quantitative design will be the most dominant in this research. Setting This study will be conducted in Bandung, the capital city of West Java, Indonesia. Bandung has 30 subdistricts, and there are 4 subdistricts that have elderly schools. Elderly schools in Bandung have 275 members and are managed by Elderly Friends. The elderly school model was established in 2019 developed by Indonesia Ramah Lansia (IRL) West Java. Activities at the Bandung Elderly School include education about elderly health concerns and home visits by Elderly Friends to monitor the health of the elderly at home.

Study stages and data collection Stage I (Qualitative Study) In the first stage, the descriptive exploratory will be used to explore the perceptions of families, the elderly, healthcare providers, and school administrators regarding the safety of the elderly at home.

研究设计

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

入排标准

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

入选标准

  • Inclusion criteria for the elderly are: living with family; have a history of adverse events over the past one year such as falls, pressure ulcers, injuries, and problems due to treatment; can communicate effectively, and have a level of dependence: independent, mild, and moderate.
  • Inclusion criteria for family are: taking care of the elderly directly, can communicate effectively, and have a minimum age of 18 years.

排除标准

  • family did not continue the study, elderly were hospitalized, and died during the study.

结局指标

主要结局

Incidence of adverse events

时间窗: 16 weeks

Adverse events will be measured by the type and frequency (no events, 1-2 events, \>3 events) experienced by the elderly at home before and after the model trial.

Rate of safety culture

时间窗: 16 weeks

Rate of safety culture will be measured by instrument of safety culture that modified from the Nursing Home Patient Safety Culture and the results of Delphi at stage 2.

次要结局

未报告次要终点

研究者

发起方
Gadjah Mada University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asri Handayani Solihin

Principal Invesigator

Gadjah Mada University

研究点 (1)

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