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Recruiting Not applicable

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

NCT07211750 · tracked via the Priya Life Science Belgium tracker
Sponsor
Phase
Not applicable
Started
2025-10-01
Last updated
2025-12-12

Condition(s) studied

MultimorbidityOlder Adults (65 Years and Older)Mood DisordersDepression - Major Depressive DisorderBipolarIntegrated Care

Investigational drug(s) / intervention(s)

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

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.

Study 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

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Physical Component Summary (PCS) score from the SF-36 — 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 — 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)

Trial sites (1)

FacilityCityRegionStatus
KU/UZ Leuven Leuven Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07211750 on ClinicalTrials.gov ↗ ← All trials in Belgium