Actively Recruiting
Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
Led by KU Leuven · Updated on 2025-12-12
82
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
K
KU Leuven
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the I-CONNECT program, an integrated care model designed for older adults aged 65 and above who have major depression or bipolar disorder along with at least two chronic physical health conditions. This study aims to see if I-CONNECT can improve overall health and well-being, enhance patient experiences, reduce treatment burden, and improve how care is delivered compared to usual care. The research also explores how well the care model is implemented and its effects on healthcare use. Participants are randomly assigned to one of two groups. The I-CONNECT group receives personalized care coordination from a trained coordinator who works closely with their general practitioner, psychiatrist, pharmacist, and specialists to create a care plan, conduct medication reviews, support shared decision-making, and provide regular follow-up either by phone or in person. The control group continues with their usual medical and mental healthcare without this additional coordination or structured follow-up. The intervention lasts for 12 months, with flexible contacts based on patients' needs. During the study, participants complete questionnaires assessing mood, quality of life, care experience, and treatment burden at multiple time points, including baseline, 3, 6, and 12 months. Their healthcare use, such as emergency visits and hospital admissions, is tracked at 6 and 12 months. Researchers measure changes in physical and mental health using the SF-36 survey at baseline and 6 months. They also monitor how the care model is delivered and gather feedback from participants and providers to understand challenges and support for broader use. The total participation period is up to 12 months.
CONDITIONS
Brief Title
Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Clinical diagnosis of a mood disorder (depression or bipolar disorder)
- Currently receiving care from a psychiatrist
- Have at least two chronic physical health conditions
- Living independently at home in the Leuven region
- Receiving ongoing care from both a general practitioner and a psychiatrist
You will not qualify if you...
- Severe cognitive impairment (such as advanced dementia) that prevents participation in assessments or shared decision-making
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 12 months
Participants receive the I-CONNECT care model, involving a trained care coordinator working with the participant and healthcare providers to create a personalized care plan, conduct structured medication reviews, support shared decision-making and self-management, and provide regular follow-up.
Flexible contacts depending on participant needs, including phone or in-person follow-ups
Duration - 12 months
Participants continue their usual medical and mental healthcare managed by their general practitioner and psychiatrist without additional intervention.
Usual care visits as scheduled by participant's healthcare providers
Trial Site Locations
Total: 1 location
1
KU/UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
L
Louise de Almeida Ferreira Fonseca
D
Denise Veltman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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