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

NCT ID: NCT07211750

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-10-30

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Goderis Geert

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU/UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Louise de Almeida Ferreira Fonseca

Role: CONTACT

louise.dealmeidaferreira@kuleuven.be

+32 16 37 66 21

Denise Veltman

Role: CONTACT

denise.veltman@kuleuven.be

Facility Contacts

Louise de Almeida Ferreira Fonseca

Role: primary

louise.dealmeidaferreirafonseca@kuleuven.be

+32683059811

Denise Veltman

Role: backup

denise.veltman@kuleuven.be

Other Identifiers

S70376

Identifier Type: -

Identifier Source: org_study_id