MultimorbidityI-CONNECTNCT07211750
Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
A study testing integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven in people with Multimorbidity and Older Adults (65 Years and Older), run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbidity, Older Adults (65 Years and Older), Mood Disorders
- What is being tested?
- integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Severe cognitive impairment (e.g., advanced dementia) that prevents participation in assessments or shared decision-making
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denise Veltman contact
Belgium1 site, 1 recruiting
- Recruiting
KU/UZ Leuven
Leuven, 3000
Louise de Almeida Ferreira Fonseca, +32683059811, louise.dealmeidaferreirafonseca@kuleuven.be
Denise Veltman, denise.veltman@kuleuven.be
About this study
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:
Read more
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
Read the 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.
- Conditions
- Multimorbidity, Older Adults (65 Years and Older), Mood Disorders, Depression - Major Depressive Disorder, Bipolar, Integrated Care
- Being tested
- integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven
- Keywords
- Integrated care, Care coordination, Person-centered care, Shared decision-making, Self-management support, Multimorbidity, Depression, Bipolar disorder, Older adults, Quality of life
- Medical subject headings
- Mood Disorders, Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in LeuvenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline and 6 months after randomization
Secondary outcomes (8)
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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 6 months and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Goderis Geert, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211750
- Sponsor's protocol ID
- S70376
- Acronym
- I-CONNECT
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT
- ClinicalTrials.gov ID
- NCT07211750
- Acronym / sponsor ID
- I-CONNECT / S70376
- Conditions
- Multimorbidity, Older Adults (65 Years and Older), Mood Disorders, Depression - Major Depressive Disorder, Bipolar, Integrated Care
- Keywords
- Integrated care, Care coordination, Person-centered care, Shared decision-making, Self-management support, Multimorbidity, Depression, Bipolar disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-CONNECT Integrated Care | Experimental | Other: integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in LeuvenParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Severe cognitive impairment (e.g., advanced dementia) that prevents participation in assessments or shared decision-making
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in LeuvenThe 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. | Other | I-CONNECT Integrated Care |
Primary outcome
Physical Component Summary (PCS) score from the SF-36
Time frame: 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
Time frame: 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)
8 secondary outcomes
Patient Assessment of Chronic Illness Care (PACIC) score
Time frame: Baseline and 6 months after randomization
Multimorbidity Treatment Burden Questionnaire (MTBQ) score
Time frame: Baseline and 6 months after randomization
Change in Physical Component Summary (PCS) score of the SF-36 over time
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
Time frame: Baseline, 3 months, 6 months, and 12 months
PACIC scores over time
Time frame: Baseline, 3 months, 6 months, and 12 months after randomization
MTBQ score over time
Time frame: Baseline, 3 months, 6 months, and 12 months after randomization
Number of emergency room visits
Time frame: 6 months and 12 months after randomization
Number of hospital admissions
Time frame: 6 months and 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denise Veltman contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidity in Leuven in people with Multimorbidity and Older Adults (65 Years and Older), run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise de Almeida Ferreira Fonseca (+32 16 37 66 21, louise.dealmeidaferreira@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Component Summary (PCS) score from the SF-36 (time frame: Baseline and 6 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.