Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT

NCT07211750 | Recruiting DMC

• 1 other identifier: S70376
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

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; Older adults; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Patient Assessment of Chronic Illness Care (PACIC) score

  Baseline and 6 months after randomization

• Multimorbidity Treatment Burden Questionnaire (MTBQ) score

  Baseline and 6 months after randomization

• Change in Physical Component Summary (PCS) score of the SF-36 over time

  Baseline, 3 months, 6 months, and 12 months after randomization

• Change in Mental Component Summary (MCS) score of the SF-36 over time

  Baseline, 3 months, 6 months, and 12 months

• PACIC scores over time

  Baseline, 3 months, 6 months, and 12 months after randomization

Other Outcomes (5)

• Fidelity of intervention delivery

  At study completion, 12 months following the randomization of the final enrolled patient.

• Intervention dose

  At study completion, 12 months after last patient randomized

• Medication review outcomes: Number of new prescriptions

  At study completion (12 months after last patient randomized)

Study Arms (2)

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.

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.

Interventions

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.

I-CONNECT Integrated Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive impairment (e.g., advanced dementia) that prevents participation in assessments or shared decision-making
• Inability to provide informed consent

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

KU/UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Depression; Bipolar Disorder

Interventions

Multimorbidity

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Comorbidity; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Louise de Almeida Ferreira Fonseca

CONTACT

+32 16 37 66 21; louise.dealmeidaferreira@kuleuven.be

Denise Veltman

CONTACT

denise.veltman@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-09

Locations

BE (1)