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Recruiting NCT07041034

SUNAM Protocol for Managing BPSD

No phase Interventional Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Comparator Group, Experimental Group.
Who it may be relevant to
Registry conditions: Dementia. Basic parameters: 65 years — 110 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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.

Interventions

  • Behavioral Active Comparator Group
    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.
  • Behavioral Experimental Group
    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 fac

Primary outcome measures

  • Change in frequency of BPSD assessment and management. [Time frame: Baseline, 2-week post-intervention, and 4-week follow-up.]
  • Change in number of unmet needs. [Time frame: Baseline, 2-week post-intervention, and 4-week follow-up.]
Secondary outcome measures (1)
  • Change in frequency of BPSD symptoms. [Time frame: Baseline, 2-week post-intervention, and 4-week follow-up.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Taiwan · 2 centers
  • Guang-En Senior Care Center — New Taipei City
  • Guang-En Senior Care Center — New Taipei City

Identifiers

NCT: NCT07041034 · MMC-RD-113-1B-P016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗