DementiaNCT07041034
SUNAM Protocol for Managing BPSD
A study testing Active Comparator Group and Experimental Group in people with Dementia, run by Mackay Medical College at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Dementia
- What is being tested?
- Active Comparator Group and Experimental Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 20 Dec 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosed with dementia or documented as having dementia in medical records.
- Currently residing in the long-term care facility.
Who cannot join
- Diagnosed with schizophrenia.
- The resident's legal representative does not provide consent for participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yi-Heng Chen, PhD contact
Taiwan2 sites, 2 recruiting
- Enrolling by invitation
Guang-En Senior Care Center
New Taipei City
- Recruiting
Guang-En Senior Care Center
New Taipei City
Guang-En Senior Care Center, 886-2-2217-3517, guannenn@guannenn.or
About this study
Official title: The Effectiveness of the Systematic Unmet Needs Assessment and Management (SUNAM) Protocol on Behavioral and Psychological Symptoms of Institutionalized Residents With Dementia
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Active Comparator Group, Experimental Group
- Keywords
- SUNAM Protocol, Behavioral and Psychological Symptoms
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator GroupBehavioural
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.
Experimental GroupBehavioural
The intervention consists of three components:
- Foundational Education: A structured session introducing key concepts of BPSD, symptom recognition, and general management approaches.
- Simulation-Based Training: An interactive training module using case-based simulation to illustrate common BPSD scenarios and guide caregivers in applying appropriate strategies.
- SUNAM Protocol Training: Instruction on a structured, theory-informed protocol aimed at identifying and addressing underlying factors that contribute to BPSD in institutionalized residents.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group will receive BPSD foundational education, VR-based training and SUNAM protocol. Receives: Behavioral: Experimental Group |
| Active Comparator Group | Active comparator | This group will receive BPSD foundational education and VR-based training. Receives: Behavioral: Active Comparator Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2-week post-intervention, and 4-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start20 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Yi-Heng C, PhD, Principal investigator, Mackay Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041034
- Sponsor's protocol ID
- MMC-RD-113-1B-P016
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Systematic Unmet Needs Assessment and Management (SUNAM) Protocol on Behavioral and Psychological Symptoms of Institutionalized Residents With Dementia
- ClinicalTrials.gov ID
- NCT07041034
- Acronym / sponsor ID
- MMC-RD-113-1B-P016
- Conditions
- Dementia
- Keywords
- SUNAM Protocol, Behavioral and Psychological Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Experimental GroupThis group will receive BPSD foundational education, VR-based training and SUNAM protocol. |
| Active Comparator Group | Active comparator | Behavioral: Active Comparator GroupThis group will receive BPSD foundational education and VR-based training. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Diagnosed with dementia or documented as having dementia in medical records.
- Currently residing in the long-term care facility.
Key exclusion criteria (2 listed)
- Diagnosed with schizophrenia.
- The resident's legal representative does not provide consent for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator GroupThe 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. | Behavioural | Active Comparator Group |
| Experimental GroupThe 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. | Behavioural | Experimental Group |
Primary outcome
Change in frequency of BPSD assessment and management.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Change in frequency of BPSD symptoms.
Time frame: Baseline, 2-week post-intervention, and 4-week follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi-Heng Chen, PhD contact
Yi-Heng C, PhD principal investigator
Mackay Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator Group and Experimental Group in people with Dementia, run by Mackay Medical College at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Heng Chen, PhD (+886-2-26360303 Ext. 1320, yiheng@mmc.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of BPSD assessment and management. (time frame: Baseline, 2-week post-intervention, and 4-week follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.