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

Not Applicable

Not yet recruiting

• Conditions: Multimorbidity; Older Adults (65 Years and Older); Mood Disorders; Depression - Major Depressive Disorder; Bipolar; Integrated Care

• Registration Number: NCT07211750
• Lead Sponsor: KU Leuven

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

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-22
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study Start: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2026-10-01
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Chronic Illness Care (PACIC) score	Baseline and 6 months after randomization	Change in care experience measured by the Patient Assessment of Chronic Illness Care (PACIC). The PACIC contains 15 items across 5 domains. Each item is scored on a 5-point Likert scale (1 = "almost never" to 5 = "almost always"), and the total score is calculated as the mean of all item scores. Thus, the overall PACIC score ranges from 1 to 5, with higher scores indicating better alignment of care with the Chronic Care Model.; Unit of Measure: Score (1-5)
Multimorbidity Treatment Burden Questionnaire (MTBQ) score	Baseline and 6 months after randomization	Change in treatment burden measured by the Multimorbidity Treatment Burden Questionnaire (MTBQ). The MTBQ assesses the perceived difficulty of managing multiple health conditions and treatments, including medication, appointments, monitoring, and lifestyle changes. Scores range from 0 to 100, with higher scores indicating greater treatment burden.
Change in Physical Component Summary (PCS) score of the SF-36 over time	Baseline, 3 months, 6 months, and 12 months after randomization	Description: Change in physical health-related quality of life measured by the PCS score of the SF-36 at multiple time points.; Unit of Measure: Score (range: 0-100)
Change in Mental Component Summary (MCS) score of the SF-36 over time	Baseline, 3 months, 6 months, and 12 months	Change in mental health-related quality of life measured by the MCS score of the SF-36 at multiple time points.; Unit of Measure: Score (range: 0-100)
PACIC scores over time	Baseline, 3 months, 6 months, and 12 months after randomization	Change in patient-reported care experience using the PACIC questionnaire at multiple time points to assess sustainability of effects.
MTBQ score over time	Baseline, 3 months, 6 months, and 12 months after randomization	Change in treatment burden measured by the MTBQ at multiple time points to assess sustainability of effects.
Number of emergency room visits	6 months and 12 months after randomization	Description: Number of emergency room visits during the study period, based on patient report and confirmed by medical records when available.; Unit of Measure: Count (visits per participant)
Number of hospital admissions	6 months and 12 months after randomization	Description: Number of hospital admissions during the study period, based on patient report and confirmed by medical records when available.; Unit of Measure: Count (admissions per participant)

Trial Locations

Locations (1)

KU/UZ Leuven; 🇧🇪 Leuven, Belgium