Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
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: integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven.
- Кому может быть актуально
- Состояния в реестре: Multimorbidity, Older Adults (65 Years and Older), Mood Disorders, Depression - Major Depressive Disorder. Базовые параметры: от 65 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this clinical trial is to learn if I-CONNECT (Integrated Care for Older Adults with Major Depression and Physical Multimorbidity) can improve the health and well-being of older adults with depression or bipolar disorder and at least two chronic physical conditions, such as diabetes or high blood pressure. It will also study if the care model improves how people experience their care, lowers treatment burden, and how well the program is delivered. Researchers will compare two groups: I-CONNECT group: participants receive care coordination, a personalized care plan, medication review, shared decision-making support, and regular follow-up from a care coordinator working with their GP, psychiatrist, pharmacist, and specialists. Usual care group: participants continue with their normal healthcare from their GP and psychiatrist. Participants will: Receive either I-CONNECT or usual care, depending on their group Complete questionnaires about their mood, quality of life, and care experience Have their healthcare use (emergency visits and hospitalizations) tracked during the study
Подробное описание
Mood disorders, including depression and bipolar disorder, are common in older adults and frequently occur alongside multiple long-term physical health problems. This combination worsens quality of life, raises mortality risk, and increases healthcare use and costs. Despite the high burden, healthcare systems often provide fragmented care, with limited coordination between providers and underuse of mental health resources.
I-CONNECT is a person-centered integrated care model designed to address these challenges. It combines professional care coordination with structured medication review, active involvement of general practitioners, psychiatrists, pharmacists, and specialists, and support for self-management through shared decision-making. By bridging primary and mental healthcare, the model seeks to reduce fragmentation, strengthen continuity of care, and improve outcomes for older adults with complex needs.
Study Objectives The primary objective is to test whether I-CONNECT improves overall health outcomes compared with usual care. Secondary objectives are to examine participants' experiences of care, the burden of managing multiple health problems, and the impact on healthcare utilization.
Hypothesis
The investigators hypothesize that the I-CONNECT intervention will:
Improve both mental and physical health outcomes,
Reduce treatment burden and stress for participants,
Enhance satisfaction with care, and
Support a more efficient use of healthcare resources.
Implementation Evaluation In addition to effectiveness, the study will assess how I-CONNECT is implemented. Process measures will include fidelity to the care model, the amount of intervention delivered, and outcomes of medication reviews. Qualitative feedback from participants and providers will help identify barriers and facilitators to scale-up and sustainability.
Вмешательства
- Другое integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven
The six guiding principles are translated into practice through a structured six-step care model. Each step operationalizes one or more principles, ensuring that the model is consistently applied across patient trajectories. The program takes 12 months, with flexible contacts depending on patient's needs.
Первичные конечные точки
- Physical Component Summary (PCS) score from the SF-36 [Срок оценки: Baseline and 6 months after randomization]
- Mental Component Summary (MCS) score from the SF-36 [Срок оценки: Baseline and 6 months after randomization]
Вторичные конечные точки (8)
- Patient Assessment of Chronic Illness Care (PACIC) score [Срок оценки: Baseline and 6 months after randomization]
- Multimorbidity Treatment Burden Questionnaire (MTBQ) score [Срок оценки: Baseline and 6 months after randomization]
- Change in Physical Component Summary (PCS) score of the SF-36 over time [Срок оценки: Baseline, 3 months, 6 months, and 12 months after randomization]
- Change in Mental Component Summary (MCS) score of the SF-36 over time [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
- PACIC scores over time [Срок оценки: Baseline, 3 months, 6 months, and 12 months after randomization]
- MTBQ score over time [Срок оценки: Baseline, 3 months, 6 months, and 12 months after randomization]
- Number of emergency room visits [Срок оценки: 6 months and 12 months after randomization]
- Number of hospital admissions [Срок оценки: 6 months and 12 months after randomization]
Критерии участия
Критерии включения
- Age 65 years or older
- Clinical diagnosis of a mood disorder (depression or bipolar disorder)
- Currently receiving care from a psychiatrist
- At least two chronic physical health conditions
- Living independently at home in the Leuven region
- Ongoing care from both a general practitioner and a psychiatrist
Критерии исключения
- Severe cognitive impairment (e.g., advanced dementia) that prevents participation in assessments or shared decision-making
- Inability to provide informed consent
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
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Бельгия · 1 центр
- KU/UZ Leuven — Leuven
Идентификаторы
NCT: NCT07211750 · S70376