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Идёт набор NCT07041034

SUNAM Protocol for Managing BPSD

Без фазы С лечением Dementia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Active Comparator Group, Experimental Group.
Кому может быть актуально
Состояния в реестре: Dementia. Базовые параметры: 65 лет — 110 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.
  • Поведенческое 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

Первичные конечные точки

  • Change in frequency of BPSD assessment and management. [Срок оценки: Baseline, 2-week post-intervention, and 4-week follow-up.]
  • Change in number of unmet needs. [Срок оценки: Baseline, 2-week post-intervention, and 4-week follow-up.]
Вторичные конечные точки (1)
  • Change in frequency of BPSD symptoms. [Срок оценки: Baseline, 2-week post-intervention, and 4-week follow-up.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Тайвань · 2 центра
  • Guang-En Senior Care Center — New Taipei City
  • Guang-En Senior Care Center — New Taipei City

Идентификаторы

NCT: NCT07041034 · MMC-RD-113-1B-P016

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗