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SUNAM Protocol for Managing BPSD

M

Mackay Medical College

Status

Not yet enrolling

Conditions

Behavioral and Psychological Symptoms of Dementia

Treatments

Behavioral: Experimental Group
Behavioral: Active Comparator Group

Study type

Interventional

Funder types

Other

Identifiers

NCT07041034
MMC-RD-113-1B-P016

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 estimated patients

Sex

All

Ages

65 to 110 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • a. Diagnosed with schizophrenia. b. Residents whose legal representative does not provide consent for participation.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Experimental Group
Experimental group
Description:
This group will receive BPSD foundational education, VR-based training and SUNAM protocol.
Treatment:
Behavioral: Experimental Group
Active Comparator Group
Active Comparator group
Description:
This group will receive BPSD foundational education and VR-based training.
Treatment:
Behavioral: Active Comparator Group

Trial contacts and locations

0

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Central trial contact

Yi-Heng Yi-Heng Chen, PhD, PhD

Data sourced from clinicaltrials.gov

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