Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT

Catholic University (KU) of Leuven

Status: Enrolling

Conditions: Integrated Care; Older Adults (65 Years and Older); Multimorbidity; Bipolar; Mood Disorders; Depression - Major Depressive Disorder

Treatments: Other: integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven

Study type: Interventional

Funder types: Other

Identifiers

NCT07211750

S70376

Details and patient eligibility

About

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

Full description

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Severe cognitive impairment (e.g., advanced dementia) that prevents participation in assessments or shared decision-making
• Inability to provide informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

I-CONNECT Integrated Care

Experimental group

Description:

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.

Treatment:

Other: integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven

Standard Care

No Intervention group

Description:

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.