Bipolar, Depression - Major Depressive Disorder, Integrated Care, Mood Disorders, Multimorbidity, Older Adults (65 Years and Older)
Conditions
Keywords
Integrated care, Care coordination, Person-centered care, Shared decision-making, Self-management support, Multimorbidity, Depression, Bipolar disorder, Older adults, Quality of life
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.
Interventions
OTHERintegrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven
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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication Review outcomes: Number of new deprescriptions | At study completion,12 months after last patient randomized | Description: Number of medications deprescribed during the study period, based on EHR data. Unit of Measure: Count (prescriptions per participant) |
| Number of participants reporting medication side effects | Time Frame: At study completion,12 months after last patient randomized | Description: Participants who experienced medication-related side effects during the study period, as reported in the EHR. Unit of Measure: Number of participants |
| Intervention dose | At study completion, 12 months after last patient randomized | 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 |
| Medication review outcomes: Number of new prescriptions | At study completion (12 months after last patient randomized) | Number of new medications prescribed during the study period, based on EHR data. Unit of Measure: Count (prescriptions per participant) |
| Fidelity of intervention delivery | At study completion, 12 months following the randomization of the final enrolled patient. | 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 |
Countries
Belgium
Contacts
Primary ContactLouise de Almeida Ferreira Fonseca
Backup ContactDenise Veltman
Outcome results
None listed