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Набор скоро начнётся NCT07496359

Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program

Без фазы С лечением Choroid Disease Caregiver Self-management Diabetes

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: CDSMP + caregiver support, Usual Care.
Кому может быть актуально
Состояния в реестре: Choroid Disease, Caregiver, Self-management, Diabetes. Базовые параметры: от 55 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
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Официальное название

Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program: A Hybrid Effectiveness-implementation Study

Обзор

The goal of this study is to evaluate the effectiveness and implementation of a dyadic management of the Chronic Disease Self-Management Program (CDSMP) for older adults with co-occurring cognitive impairment and diabetes with the involvement of caregivers. The main questions it aims to answer are: * Does the intervention improve diabetes self-management and cognitive function in older adults? * How is the implementation of the intervention in real-world settings? Participants will: * Attend weekly CDSMP session over a 6-week period (2.5-hour per session). * Provide feedback on their experience with the intervention through interviews and surveys.

Вмешательства

  • Поведенческое CDSMP + caregiver support
    The CDSMP is an evidence-based program consisting of 2.5-hour sessions held weekly over a six-week period, delivered by two trained leaders per session in person.
  • Поведенческое Usual Care
    Usual care (diabetes education, glucose monitoring and medical consultation)

Первичные конечные точки

  • Self-Care of Diabetes Index [Срок оценки: From enrollment to 6 months after the intervention begins]
Вторичные конечные точки (12)
  • Glycated hemoglobin (HbA1c) [Срок оценки: From enrollment to 6 months after the intervention begins]
  • Subjective Cognitive Decline Questionnaire 21 [Срок оценки: From enrollment to 6 months after the intervention begins]
  • Montreal Cognitive Assessment [Срок оценки: From enrollment to 6 months after the intervention begins]
  • Caregiver Contribution to Self-Care of Diabetes Inventory [Срок оценки: From enrollment to 6 months after the intervention begins]
  • Caregiver Burden Inventory [Срок оценки: From enrollment to 6 months after the intervention begins]
  • Implementation Outcome: Acceptability of Intervention Measure [Срок оценки: From 3 months after the intervention begins to 6 months after the intervention begins]
  • Implementation Outcome: Intervention Appropriateness Measure [Срок оценки: From 3 months after the intervention begins to 6 months after the intervention begins]
  • Implementation Outcome: Feasibility of Intervention Measure [Срок оценки: From 3 months after the intervention begins to 6 months after the intervention begins]
  • Implementation Outcome: Adoption [Срок оценки: From 3 months after the intervention begins to 6 months after the intervention begins]
  • Implementation Outcome: Fidelity [Срок оценки: From 3 months after the intervention begins to 6 months after the intervention begins]
  • Implementation Outcome: Cost [Срок оценки: From 3 months after the intervention begins to 6 months after the intervention begins]
  • Implementation Outcome: Penetration [Срок оценки: From 3 months after the intervention begins to 6 months after the intervention begins]

Критерии участия

Критерии включения

  • Individuals with DM aged >= 55 years old;
  • Recent glycosylated haemoglobin (HbA1c) level of 6.5% or above without change in diabetes medication within the last 3 months based on centre's records;
  • Subjective cognitive decline (using SCDQ21) (separately reported by the patient and/or caregiver) and confirmed by MOCA (Chinese version) screened by the research nurses;
  • Subjects with nominated primary caregivers will be recruited in the intervention group;
  • For caregivers: they will be considered in the project if they have been the primary caregiver for the person for at least 1 year and are providing or involved in the patient's care on a daily basis.

Критерии исключения

  • Medical diagnoses of dementia;
  • Those who have terminal illness;
  • For caregivers: those who are temporary caregivers and have only provided/involved in care for less than a year.

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
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07496359 · 22231531

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗