Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Physical Component Summary (PCS) score from the SF-36
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe cognitive impairment (e.g., advanced dementia) that prevents participation in assessments or shared decision-making
- •Inability to provide informed consent
研究组 & 干预措施
I-CONNECT Integrated Care
Participants receive the I-CONNECT care model: a trained care coordinator works with the participant, GP, psychiatrist, pharmacist, and specialists to create a personalized care plan, conduct a structured medication review, support shared decision-making and self-management, and provide regular follow-up (phone or in-person) to monitor progress and adjust care.
干预措施: integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven (Other)
Standard Care
Participants continue their usual medical and mental healthcare. Their general practitioner and psychiatrist manage care as normally provided, without additional I-CONNECT coordination, medication review protocol, or structured follow-up from a care coordinator.
结局指标
主要结局
Physical Component Summary (PCS) score from the SF-36
时间窗: Baseline and 6 months after randomization
Change in the PCS score of the Short Form (SF-36) Health Survey, which reflects the physical health dimension of quality of life. A clinically meaningful improvement is defined as an increase of at least 5 points. Unit of Measure: Score (0-100)
Mental Component Summary (MCS) score from the SF-36
时间窗: Baseline and 6 months after randomization
The MCS score from the Short Form-36 (SF-36) Health Survey will be used to evaluate the mental health dimension of quality of life. A clinically meaningful improvement is defined as an increase of at least 5 points. Unit of Measure: Score (0-100)
次要结局
- Patient Assessment of Chronic Illness Care (PACIC) score(Baseline and 6 months after randomization)
- Multimorbidity Treatment Burden Questionnaire (MTBQ) score(Baseline and 6 months after randomization)
- Change in Physical Component Summary (PCS) score of the SF-36 over time(Baseline, 3 months, 6 months, and 12 months after randomization)
- Change in Mental Component Summary (MCS) score of the SF-36 over time(Baseline, 3 months, 6 months, and 12 months)
- PACIC scores over time(Baseline, 3 months, 6 months, and 12 months after randomization)
- MTBQ score over time(Baseline, 3 months, 6 months, and 12 months after randomization)
- Number of emergency room visits(6 months and 12 months after randomization)
- Number of hospital admissions(6 months and 12 months after randomization)