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Набор скоро начнётся NCT07216950

Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)

Без фазы С лечением Elder Mistreatment Elder Abuse Quality of Care 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: Knowledge and Interpersonal Skills to Develop Enhanced Relationships, Healthy Living for the Caregiver.
Кому может быть актуально
Состояния в реестре: Elder Mistreatment, Elder Abuse, Quality of Care, 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
США
Следующий шаг
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Официальное название

Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER): Testing the Efficacy of an Intervention to Prevent Psychological Elder Abuse in Family Caregiving

Обзор

The Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) intervention was developed to prevent psychological elder abuse (EA) and promote high-quality caregiving by lowering relationship strain and developing CG resourcefulness. The goal of this two-arm, randomized control trial is to determine the efficacy of KINDER at mitigating psychological EA by family caregivers to persons living with dementia and to describe how the intervention may work to reduce psychological EA.

Вмешательства

  • Поведенческое Knowledge and Interpersonal Skills to Develop Enhanced Relationships
    KINDER is an 8-week intervention that consists of three facilitated group discussion sessions conducted over Zoom with a small group of caregivers, in addition to self-paced lessons delivered using a printed or PDF workbook, depending on participant preference. Throughout KINDER, caregivers reflect on their relationship, including how their behavior toward the care recipient may need to change considering new vulnerabilities with dementia, and how to communicate about topics that often contribut
  • Поведенческое Healthy Living for the Caregiver
    Caregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition).

Первичные конечные точки

  • Psychological Elder Abuse [Срок оценки: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention]
  • Quality of Caregiving [Срок оценки: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention]
Вторичные конечные точки (2)
  • Resourcefulness [Срок оценки: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention]
  • Caregiving Relationship Strain [Срок оценки: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention]

Критерии участия

Критерии включения

  • Age range: from 18 to No upper limit;
  • Be a family member to an individual living with AD/ADRD;
  • Provide assistance with at least two instrumental activities of daily living or one activity of daily living;
  • Provides at least 4 hours of caregiving per day and sees the care recipient in-person at least 2 times per week on average
  • The care recipient is at least age 65 or older
  • Report an AD8 Dementia Screening score for care recipients of at least 2;
  • Commit to attending at three discussion sessions;
  • Have reliable access to internet and email, and to be able to attend synchronous sessions using the Zoom videoconferencing platform.
  • Caregiver lives in any of the following states, which may require mandetory reporting of elder mistreatment when responding to survey questions:

Delaware, Florida, Indiana, Kentucky, Louisiana, Mississippi, Montana, New Hampshire, New Mexico, North Carolina, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah, Wyoming

Критерии исключения

  • Are unable to read or speak English;
  • Previously participated in Learning Skills Together (NCT05846984) or KINDER pilot study;
  • Have plans to place the care recipient in a skilled nursing facility within the next 8 months (i.e., study duration)

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
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Case Western Reserve University — Cleveland

Идентификаторы

NCT: NCT07216950 · STUDY20250080

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗