{"type":"trials","record":{"id":43962,"source_id":"clinicaltrials-gov","external_id":"NCT07211750","title":"Integrated Care for Older Adults With Major Depression and Physical Multimorbidity - The I-CONNECT","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","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"KU Leuven","enrollment":82,"countries":["Belgium"],"start_date":"2025-10-01","completion_date":"2027-10-30","last_update_date":"2025-12-12","source_url":"https://clinicaltrials.gov/study/NCT07211750","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:45.944732+00:00","last_seen_at":"2026-09-25T06:25:30.723+00:00","metadata":{"sex":"ALL","acronym":"I-CONNECT","age_range":"65 Years","comparator":"Standard Care","organization":"KU Leuven","interventions":["integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidi…"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Physical Component Summary (PCS) score from the SF-36 — Baseline and 6 months after randomization","Mental Component Summary (MCS) score from the SF-36 — Baseline and 6 months after randomization","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 a…","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","MTBQ score over time — Baseline, 3 months, 6 months, and 12 months after randomization","Number of emergency room visits — 6 months and 12 months after randomization","Number of hospital admissions — 6 months and 12 months after randomization"],"design_description":"RANDOMIZED · PARALLEL · HEALTH SERVICES RESEARCH · NONE","source_has_results":false},"controlled_terms":["Multimorbidity","Older Adults (65 Years and Older)","Mood Disorders","Depression - Major Depressive Disorder","Bipolar","Integrated Care","integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidi…"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: multimorbidity.","quality_checked_at":"2026-09-25T06:25:35.871646+00:00","duplicate_cluster_key":"id:nct07211750","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-10-01 to 2027-10-30","comparator":"Standard Care","confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:30.738Z","intervention":["integrated care intervention tailored to the needs of older adults leaving at home with mood disorders and multimorbidi…"],"participants":82,"study_design":"RANDOMIZED · PARALLEL · HEALTH SERVICES RESEARCH · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Physical Component Summary (PCS) score from the SF-36 — Baseline and 6 months after randomization","Mental Component Summary (MCS) score from the SF-36 — Baseline and 6 months after randomization","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 a…","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","MTBQ score over time — Baseline, 3 months, 6 months, and 12 months after randomization","Number of emergency room visits — 6 months and 12 months after randomization","Number of hospital admissions — 6 months and 12 months after randomization"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"multimorbidity","is_published":true,"match_reasons":["Title contains controlled term: multimorbidity.","Abstract contains controlled term: multimorbidity.","Source terminology contains: multimorbidity.","Title supplies longevity context: older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Multimorbidity","slug":"multimorbidity"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/43962","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}