Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07211750

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Integrated Care Intervention

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

Standard Care

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

Loading map...

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

Similar Trials

The Effects of Citalopram on the Brain's Response to Emotion...

Emotional Processing

Actively Recruiting

1 location

A Novel Blood Test as a Differential Diagnosis and Drug Effi...

Depression - Major Depressive Disorder

Actively Recruiting

1 location

A Pilot Randomized Controlled Trial of a Social Network Inte...

Advanced Cancer

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here