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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-CONNECT Integrated Care | Experimental | Participants receive the I-CONNECT care model: a trained care coordinator works with the participant, GP, psychiatrist, pharmacist, and specialists to create a personalized care plan, conduct a structured medication review, support shared decision-making and self-management, and provide regular follow-up (phone or in-person) to monitor progress and adjust care. |
|
| Standard Care | No Intervention | Participants continue their usual medical and mental healthcare. Their general practitioner and psychiatrist manage care as normally provided, without additional I-CONNECT coordination, medication review protocol, or structured follow-up from a care coordinator. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven | Other | The six guiding principles are translated into practice through a structured six-step care model. Each step operationalizes one or more principles, ensuring that the model is consistently applied across patient trajectories. The program takes 12 months, with flexible contacts depending on patient's needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Component Summary (PCS) score from the SF-36 | 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) | Baseline and 6 months after randomization |
| Mental Component Summary (MCS) score from the SF-36 | 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) | Baseline and 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Chronic Illness Care (PACIC) score | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity of intervention delivery | Adherence to delivering core components of the intervention, such as first appointment, life goal assessment, medication review, and proactive follow-up. Measured as the percentage of participants receiving each planned component. Electronic health records (EHRs) will also be reviewed to confirm delivery. Unit of Measure: Percentage of participants | At study completion, 12 months following the randomization of the final enrolled patient. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise de Almeida Ferreira Fonseca | Contact | +32 16 37 66 21 | louise.dealmeidaferreira@kuleuven.be | |
| Denise Veltman | Contact | denise.veltman@kuleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU/UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Baseline and 6 months after randomization |
| Multimorbidity Treatment Burden Questionnaire (MTBQ) score | 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. | Baseline and 6 months after randomization |
| Change in Physical Component Summary (PCS) score of the SF-36 over time | 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) | Baseline, 3 months, 6 months, and 12 months after randomization |
| Change in Mental Component Summary (MCS) score of the SF-36 over time | 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) | Baseline, 3 months, 6 months, and 12 months |
| PACIC scores over time | Change in patient-reported care experience using the PACIC questionnaire at multiple time points to assess sustainability of effects. | Baseline, 3 months, 6 months, and 12 months after randomization |
| MTBQ score over time | Change in treatment burden measured by the MTBQ at multiple time points to assess sustainability of effects. | Baseline, 3 months, 6 months, and 12 months after randomization |
| Number of emergency room visits | 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) | 6 months and 12 months after randomization |
| Number of hospital admissions | 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) | 6 months and 12 months after randomization |
| Intervention dose | Intensity of the intervention received by patients, measured as the frequency of follow-up contacts compared with the planned individualized care schedule. Data obtained from EHRs. Unit of Measure: number of follow-up contacts per participant | At study completion, 12 months after last patient randomized |
| Medication review outcomes: Number of new prescriptions | Number of new medications prescribed during the study period, based on EHR data. Unit of Measure: Count (prescriptions per participant) | At study completion (12 months after last patient randomized) |
| Medication Review outcomes: Number of new deprescriptions | Description: Number of medications deprescribed during the study period, based on EHR data. Unit of Measure: Count (prescriptions per participant) | At study completion,12 months after last patient randomized |
| Number of participants reporting medication side effects | Description: Participants who experienced medication-related side effects during the study period, as reported in the EHR. Unit of Measure: Number of participants | Time Frame: At study completion,12 months after last patient randomized |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D003863 | Depression |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D000076322 | Multimorbidity |
| ID | Term |
|---|---|
| D015897 | Comorbidity |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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