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临床试验/NCT06003647
NCT06003647尚未招募不适用

Educational Intervention Among Informal Caregivers of Person With Dementia in Klang Valley, Malaysia

Universiti Putra Malaysia0 个研究点目标入组 174 人开始时间: 2023年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
174
主要终点
Caregiver Burden

研究概览

简要总结

The goal of this intervention study is to test whether the educational intervention work well or not on informal caregiver of person with dementia. The main question it aims to answer is does the educational intervention will help to reduce the caregiver burden experience by the informal caregiver.

Participants will be given an educational module and short videos that they can refer to gain more knowledge and skills in caring for the person with dementia.

详细描述

Caregivers for this study will be recruited at the geriatric, neurology and, psychiatry outpatient clinic. The caregiver will be approached by the primary researcher and explained about the details of the study. The caregivers will be given the participant information sheet and if they agree to participate in the study, written informed consent will be obtained.

The researcher will then check the eligibility of the caregiver to participate. If the caregiver was eligible to participate, they will be ask to provide contact details for researcher to assign tentative date for the virtual educational session. The caregiver will be then randomly assigned to control or intervention group before the baseline data were collected. This study will use equal allocation with a ratio of one to one for each two groups. The caregiver will be randomly allocated by using permuted block randomization technique. This study will be conducted as single blind study. Only the respondents would be blinded and concealed from the group allocation.

The intervention group will be given the educational intervention which are educational module and short videos related to dementia care. After the baseline data collection, the soft copy of the educational module will be shared to the participants via WhatsApp messenger so that they can review the module before the virtual educational session. One short educational video will be then shared to all the participants through individual WhatsApp in each Wednesday of the week for 12 weeks. Each of the short video will contain subtopics of the educational module and each video will be around two to three minutes. After the video shared to the participants, they are encouraged to ask any questions related to the content of the video.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

  • Informal caregiver of person with dementia (children, children in law, grandchildren, grandchildren in law, spouses, siblings, parents).
  • Age 18 years old and above.
  • Able to understand, read and speak Bahasa Malaysia language

排除标准

  • Caregiver with previous history of mental illness.
  • Caregiver with physical disabilities that cause limitation in providing care for person with dementia.
  • Paid informal caregiver (maid).

结局指标

主要结局

Caregiver Burden

时间窗: Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention

The caregiver burden measured by using Zarit Burden Interview (ZBI). ZBI consisted of 22 items with all negative statements. The scoring will be zero for never, one for rarely, two for sometimes, three for quite frequently and four for nearly always. The scoring can be from zero to 88 with scoring of 0 to 21 little or no burden, 21 to 40 mild to moderate burden, 41 to 60 moderates to severe burden, and 61 to 88 severe burdens.

次要结局

  • Caregiver knowledge on dementia(Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention)
  • Caregiving characteristics(Baseline)
  • Socio-demographic characteristic(Baseline)
  • Caregiver mastery(Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention)
  • Caregiver stress coping(Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention)
  • Caregiver self-esteem(Baseline, 2 weeks after the end of educational intervention session, and 3 months after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuraisyah Hani Binti Zulkifley

Principal Investigator

Universiti Putra Malaysia

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