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
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
Severe cognitive impairment (e.g., advanced dementia) that prevents participation in assessments or shared decision-making
Inability to provide informed consent
Parallel
integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven
Other interventionThe 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.
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)
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)
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)
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.
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)
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)
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
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
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)
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)
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KU Leuven
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
