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Набор скоро начнётся NCT06636214

Adapting Changing Talk: Online (CHATO) to CHATO-Inclusive

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: CHATO-I.
Кому может быть актуально
Состояния в реестре: Dementia. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Adapting the CHATO Communication Intervention for Diverse Nursing Home Communities

Обзор

This study will adapt and test online interactive training for nursing home staff that improves staff communication and reduces behavioral symptoms of persons with dementia that they care for. This research will adapt and test communication training to meet the needs of nursing homes to improve dementia care.

Подробное описание

A person is diagnosed with Alzheimer's disease or related dementia (AD/ADRD) every 65 seconds, and most persons living with dementia (PLWD) experience nursing home (NH) care at some stage. NH staff shortages and lack of dementia care skills limit care quality, especially in NHs with low income and resources. Care is complicated by the behavioral and psychological symptoms of dementia (BPSD) of PLWD who cannot express their unmet physical and psychosocial needs. BPSD increase staff stress and time to complete care and contribute to staff turnover, injury, and inappropriate psychotropic medication use.

The PI and other researchers have empirically verified that BPSD occur when staff use elderspeak (speech like baby talk) that features inappropriately intimate terms of endearment (diminutives such as "honey"), belittling pronoun substitutions that imply dependence ("we" need a bath), and harsh task-oriented commands ("sit down"). Elderspeak conveys a message of disrespect and incompetence to PLWD who react with withdrawal or BPSD. The investigators R03 study first established that elderspeak use more than doubled the occurrences of resident responses of BPSD (measured by timed sequential behavioral analyses of BPSD in relation to type of staff communication in video data). The investigators R01 trial (NR011455) confirmed that the three-session Changing Talk(CHAT) staff education intervention reduced staff elderspeak use that significantly reduced resident BPSD.The evidence-based CHAT intervention was transitioned to online modules (CHATO), maintaining content, active engagement, and application activities, with equal knowledge gain (mechanism of action) and improved participation and completion rates. The investigators are currently testing CHATO in a pragmatic national trial in 128 NHs (R01AG069171). However, NHs serving high minority-resident populations with fewer resources and staff and more frequent and serious care deficiencies, including high antipsychotic medication use rates, have been less likely to respond to recruitment and study participation. Research has established that tailoring interventions and intensification of recruitment and implementation approaches are frequently necessary to reach and achieve intervention success to overcome health care disparities in diverse care settings.

This study will first engage NH staff in completing the current CHATO training and providing in depth focus groups feedback. We will then integrate focus group findings with findings from our CHATO study and expert stakeholder panel advise to streamline content, improve format and user interface, and expand implementation support to create CHATO-I, designed to increase appropriateness and uptake across NH communities. The investigators will then conduct a cluster randomized trial in NHs (N=40). NHs will be randomized to intervention or waitlist control groups and one of two waves for staff completion of the CHATO-I intervention with high intensity implementation support. The investigators will test feasibility and acceptability and use hierarchical mixed modeling analyses to evaluate preliminary effects of the intervention on BPSD and psychoactive medication use by residents with dementia in a pragmatic evaluation of Electronic Medical Record (EMR) data.

Aim 1 (years 1 and 2): Tailor recruitment, implementation support, and intervention content and format appropriate for all NHs. Administrators, directors of nursing, and care staff including certified nursing assistants (CNAs) from six NHs (N=24) will complete current CHATO and participate in focus groups. Thematic analyses of transcribed recordings will identify tailoring modifications to support uptake across all varieties of NH communities. The ADAPT framework will guide CHATO to CHATO-I adaptation with support from expert consultants and stakeholders.

Aim 2 (years 3 to 5): Test feasibility, acceptability, and preliminary effects of CHATO-I in 40 NHs in a cluster-randomized waitlist-controlled trial. Enrollment and completion rates will be used to evaluate feasibility and acceptability (Aim 2a). Mixed modeling will evaluate change in resident BPSD and psychoactive medication use from eight quarters of Minimum Data Set (MDS) and Nursing Home Quality Measure (NHQM) data (Aim 2b). We hypothesize that CHATO-I will reduce resident BPSD and psychoactive medication use.

Aim 3 (years 3 to 5): Validate the mechanism of action of CHATO-I. Additional modeling analyses will evaluate the effects of CHATO-I on learning outcomes (gains in knowledge, confidence, recognition) and intention to use learned skills on resident BPSD and psychoactive medication use. We hypothesize that greater staff knowledge gain and intention to use new skills will be associated with greater outcome reductions.

This Stage 1B research will adapt and test the evidence-based CHATO intervention across NHs, increasing dissemination and improving care (reduced BPSD and psychotropic medication use). This research addresses the National Plan to Address Alzheimer's disease goals, NIA's milestones for nonpharmacological interventions, and the National Academy National Imperative for interventions to improve NH care quality.

Вмешательства

  • Поведенческое CHATO-I
    Online communication education program

Первичные конечные точки

  • Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 pre/post intervention [Срок оценки: pre (3 months) / post (3 months) post intervention]
  • Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 pre/post intervention [Срок оценки: pre (3 months) / post (3 months) post intervention]
  • Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E1100 pre/post intervention [Срок оценки: pre (3 months) / post (3 months) post intervention]
  • Test CHATO's effects on psychotropic medication - Change in MDS N0410 pre/post intervention [Срок оценки: pre (3 months) / post (3 months) post intervention]
  • Test CHATO's effects on psychotropic medication - Change in NHQM Prescribed Antipsychotic pre/post intervention [Срок оценки: pre (3 months) / post (3 months) post intervention]
  • Test CHATO's effects on psychotropic medication - Change in Survey 757 and 758 Noncompliance [Срок оценки: pre (3 months) / post (3 months) post intervention]
Вторичные конечные точки (3)
  • Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Knowledge at post intervention [Срок оценки: post intervention]
  • Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Communication Ratings [Срок оценки: post intervention]
  • Analyze NH strategies to engage staff and maximize CHATO effects _ Implementation Strategies utilized during the training phase [Срок оценки: post intervention]

Критерии участия

Критерии включения

  • Medicare certified NHs (N=40) caring for residents diagnosed with AD/ADRD.
  • CNAs, nurses, and other direct care staff who are permanent employees of participating NHs and who provide direct care at least 8 hours weekly will complete the CHATO-I training, available by URL link.
  • All staff will be encouraged to participate as high staff participation is desired to achieve facility-wide communication change. NHs will provide the number of eligible staff participants.
  • Data for residents in participating NHs with AD/ADRD documented on the MDS Active Diagnoses list will be included in the analyses as well as MDS data for: age, sex, race and ethnicity, frailty (MDS-CHESS scale), and level of cognitive function (MDS Cognitive Performance Scale).

Критерии исключения

  • NHs serving 25% of residents admitted prior to age 65 will be excluded (screening out NHs serving primarily younger persons with serious mental illnesses).
  • CNAs, nurses, and other direct care staff who do not meet the inclusion criteria.
  • Resident data excluded from MDS includes active psychiatric diagnoses (bipolar disorder, major depressive episode, schizophrenia or schizoaffective disorder, mood disorder with psychotic features, psychotic symptoms, hallucinations, or delusions); terminal illness (on hospice); and lack of response to staff (MDS section B).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06636214 · R01AG085177

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗