SUNAM Protocol for Managing BPSD

NCT07041034 | Recruiting

• 1 other identifier: MMC-RD-113-1B-P016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dementia

Keywords

SUNAM Protocol; Behavioral and Psychological Symptoms

Outcome Measures

Primary Outcomes (2)

• Change in frequency of BPSD assessment and management.

  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.

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

• Change in number of unmet needs.

  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.

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

Secondary Outcomes (1)

• Change in frequency of BPSD symptoms.

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Experimental Group

Active Comparator Group

ACTIVE COMPARATOR

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

Behavioral: Active Comparator Group

Interventions

Active Comparator Group BEHAVIORAL

The group will receive: 1.Foundational Education: A structured session introducing key concepts of BPSD, symptom recognition, and general management approaches. 2.Simulation-Based Training: An interactive training module using case-based simulation to illustrate common BPSD scenarios and guide caregivers in applying appropriate strategies. This group will not receive the protocol-based intervention component.

Active Comparator Group

Experimental Group BEHAVIORAL

The intervention consists of three components: 1. Foundational Education: A structured session introducing key concepts of BPSD, symptom recognition, and general management approaches. 2. Simulation-Based Training: An interactive training module using case-based simulation to illustrate common BPSD scenarios and guide caregivers in applying appropriate strategies. 3. SUNAM Protocol Training: Instruction on a structured, theory-informed protocol aimed at identifying and addressing underlying factors that contribute to BPSD in institutionalized residents.

Experimental Group

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mackay Medical College: lead

Study Sites (2)

Guang-En Senior Care Center

New Taipei City, Taiwan

ENROLLING BY INVITATION

Guang-En Senior Care Center

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Dementia; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yi-Heng C, PhD

  Mackay Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Heng Chen, PhD

CONTACT

+886-2-26360303 Ext. 1320; yiheng@mmc.edu.tw

Yi-Heng Chen, PhD

CONTACT

yiheng@mmc.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Office of Research and Development

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)