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

Sponsor
KU Leuven
Study ID
NCT07211750
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Oct 8, 2025
Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Oct 1, 2026
Completion
Oct 30, 2027

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Physical Component Summary (PCS) score from the SF-36 [ Time Frame: Baseline and 6 months after randomization ]

Central Contacts

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