RecruitingNot Applicable

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

Belgium82 participantsStarted 2025-10-01

Plain-language 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

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and 6 months after randomization

Mental Component Summary (MCS) score from the SF-36

Timeframe: Baseline and 6 months after randomization

Trial details

NCT IDNCT07211750

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Louise de Almeida Ferreira Fonseca

+32 16 37 66 21 louise.dealmeidaferreira@kuleuven.be

View on ClinicalTrials.gov More Multimorbidity trials