SUNAM Protocol for Managing BPSD
ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-110
SponsorMackay Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with dementia or documented as having dementia in medical records.
Currently residing in the long-term care facility.
Disqualifiers
Diagnosed with schizophrenia.
The resident's legal representative does not provide consent for participation.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Comparator Group
BehavioralThe 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.
Experimental Group
BehavioralThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Active Comparator GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 2-week post-intervention, and 4-week follow-up.2
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.
Time frame
Baseline, 2-week post-intervention, and 4-week follow-up.Secondary outcomes
1
Change in frequency of BPSD symptoms.
Measured using a 34-item composite checklist developed by integrating the 29 items from the Cohen-Mansfield Agitation Inventory (CMAI) with five additional commonly observed emotional and psychiatric symptoms in dementia (e.g., anxiety, depression, hallucinations, delusions, refusal to eat or care), with each item rated on a 7-point scale based on observed frequency over the past two weeks. Higher scores reflect greater symptom severity.
Time frame
Baseline, 2-week post-intervention, and 4-week follow-up.Sponsors and contacts
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Source ClinicalTrials.gov