An interventional study of integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven in Multimorbidity, Older Adults (65 Years and Older) and Mood Disorders, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by KU Leuven · Not applicable, Interventional, and Health services research
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.
584 studies on the registry are indexed under Mood Disorders; 117 are open to participants now.
This study's planned enrollment of 82 is above the median of 72 across 429 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven
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.
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.
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)
Time frame: 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)
Time frame: Baseline and 6 months after randomization
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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 6 months and 12 months after randomization
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
Time frame: At study completion, 12 months following the randomization of the final enrolled patient.
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
Time frame: 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)
Time frame: 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)
Time frame: 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: Time Frame: At study completion,12 months after last patient randomized
Plan to share: Undecided
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