跳至主要内容
临床试验/NCT07041034
NCT07041034招募中不适用

The Effectiveness of the Systematic Unmet Needs Assessment and Management (SUNAM) Protocol on Behavioral and Psychological Symptoms of Institutionalized Residents With Dementia

Mackay Medical College2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Change in frequency of BPSD assessment and management.

研究概览

简要总结

This study evaluates the effectiveness of the Systematic Unmet Needs Assessment and Management (SUNAM) Protocol, an algorithm-based intervention developed from the unmet needs theory of BPSD, in reducing Behavioral and Psychological Symptoms of Dementia (BPSD) among institutionalized residents. Both the experimental and control groups received 100 minutes of BPSD foundational education and 100 minutes of VR simulation training. The experimental group received an additional 150 minutes of SUNAM protocol training. The study aims to determine whether integrating SUNAM into caregiver training enhances BPSD assessment, management, and reduction by addressing unmet needs.

详细描述

Background:Behavioral and Psychological Symptoms of Dementia (BPSD) are common and distressing for dementia residents and their caregivers. These symptoms often arise from unmet needs, yet current care practices frequently fail to systematically identify and address them. As a result, effective management of BPSD remains a significant challenge in long-term care settings.

Purpose:This study aims to evaluate the effectiveness of the Systematic Unmet Needs Assessment and Management (SUNAM) Protocol, an algorithm-based intervention developed based on the unmet needs theory of BPSD. The intervention focuses on identifying and addressing unmet needs to reduce BPSD and improve care outcomes by enhancing caregivers' ability to manage these symptoms more effectively.

Methods:This is a cluster-randomized controlled trial with a repeated measures design conducted across long-term care (LTC) facilities. Both the experimental and control groups received 100 minutes of BPSD foundational education and 100 minutes of VR-based training. The experimental group additionally received 150 minutes of training on the Systematic Unmet Needs Assessment and Management (SUNAM) Protocol, an algorithm-based intervention developed to identify and address unmet needs related to BPSD. Resident data, including demographics, medical conditions, Barthel Index, and MMSE scores, were collected. Outcome measures included the frequency of BPSD, the number of unmet needs, and the frequency of BPSD assessment and management, all of which were assessed for the past two weeks at three time points (pre-intervention, two weeks after the intervention, and four-week follow-up). Data analysis was performed using SPSS 25.0, with descriptive statistics and mixed linear models to examine improvements within and between groups over time.

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
65 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with dementia or documented as having dementia in medical records.
  • Currently residing in the long-term care facility.

排除标准

  • Diagnosed with schizophrenia.
  • The resident's legal representative does not provide consent for participation.

研究组 & 干预措施

Experimental Group

Experimental

This group will receive BPSD foundational education, VR-based training and SUNAM protocol.

干预措施: Experimental Group (Behavioral)

Active Comparator Group

Active Comparator

This group will receive BPSD foundational education and VR-based training.

干预措施: Active Comparator Group (Behavioral)

结局指标

主要结局

Change in frequency of BPSD assessment and management.

时间窗: Baseline, 2-week post-intervention, and 4-week follow-up.

Measured using a structured checklist documenting the weekly frequency (over the past two weeks) of caregivers' assessment of BPSD, use of non-pharmacological interventions, and referrals to other professionals.

Change in number of unmet needs.

时间窗: Baseline, 2-week post-intervention, and 4-week follow-up.

Measured using a 27-item Dementia Unmet Needs Checklist covering physical, psychological, social, and environmental domains. Items are rated yes/no (1/0), with higher scores indicating more unmet needs.

次要结局

  • Change in frequency of BPSD symptoms.(Baseline, 2-week post-intervention, and 4-week follow-up.)

研究者

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

Chin-Tsung Shen

The Office of Research and Development

Mackay Medical College

研究点 (2)

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