Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 5:30 PM
Study NCT ID:
NCT07041034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUNAM Protocol for Managing BPSD
Sponsor:
Mackay Medical College
Organization:
Study Overview
Official Title:
The Effectiveness of the Systematic Unmet Needs Assessment and Management (SUNAM) Protocol on Behavioral and Psychological Symptoms of Institutionalized Residents With Dementia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: