Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-26 @ 7:49 PM
Study NCT ID:
NCT07211750
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
Sponsor:
KU Leuven
Organization:
Study Overview
Official Title:
Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-CONNECT
Brief 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
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
Detailed Description:
Mood disorders, including depression and bipolar disorder, are common in older adults and frequently occur alongside multiple long-term physical health problems. This combination worsens quality of life, raises mortality risk, and increases healthcare use and costs. Despite the high burden, healthcare systems often provide fragmented care, with limited coordination between providers and underuse of mental health resources.
I-CONNECT is a person-centered integrated care model designed to address these challenges. It combines professional care coordination with structured medication review, active involvement of general practitioners, psychiatrists, pharmacists, and specialists, and support for self-management through shared decision-making. By bridging primary and mental healthcare, the model seeks to reduce fragmentation, strengthen continuity of care, and improve outcomes for older adults with complex needs.
Study Objectives The primary objective is to test whether I-CONNECT improves overall health outcomes compared with usual care. Secondary objectives are to examine participants' experiences of care, the burden of managing multiple health problems, and the impact on healthcare utilization.
Hypothesis
The investigators hypothesize that the I-CONNECT intervention will:
Improve both mental and physical health outcomes,
Reduce treatment burden and stress for participants,
Enhance satisfaction with care, and
Support a more efficient use of healthcare resources.
Implementation Evaluation In addition to effectiveness, the study will assess how I-CONNECT is implemented. Process measures will include fidelity to the care model, the amount of intervention delivered, and outcomes of medication reviews. Qualitative feedback from participants and providers will help identify barriers and facilitators to scale-up and sustainability.
I-CONNECT is a person-centered integrated care model designed to address these challenges. It combines professional care coordination with structured medication review, active involvement of general practitioners, psychiatrists, pharmacists, and specialists, and support for self-management through shared decision-making. By bridging primary and mental healthcare, the model seeks to reduce fragmentation, strengthen continuity of care, and improve outcomes for older adults with complex needs.
Study Objectives The primary objective is to test whether I-CONNECT improves overall health outcomes compared with usual care. Secondary objectives are to examine participants' experiences of care, the burden of managing multiple health problems, and the impact on healthcare utilization.
Hypothesis
The investigators hypothesize that the I-CONNECT intervention will:
Improve both mental and physical health outcomes,
Reduce treatment burden and stress for participants,
Enhance satisfaction with care, and
Support a more efficient use of healthcare resources.
Implementation Evaluation In addition to effectiveness, the study will assess how I-CONNECT is implemented. Process measures will include fidelity to the care model, the amount of intervention delivered, and outcomes of medication reviews. Qualitative feedback from participants and providers will help identify barriers and facilitators to scale-up and sustainability.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: