[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06840587":3,"trial-entities:NCT06840587":112,"trial-summary:NCT06840587":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":44,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":74,"locations":77,"central_contacts":100,"overall_officials":107,"references":110,"see_also_links":111},"NCT06840587","24-2766","Connect-Home: Alzheimer's Disease and Related Dementias","Transitional Care for Skilled Nursing Facility Patients With Alzheimer's Disease and Related Dementias and Their Caregivers: a Cluster Randomized Trial","RECRUITING","2027-06-30","2026-03","2026-03-30","2025-04-04","University of North Carolina, Chapel Hill","OTHER",true,"This study is a parallel arm, cluster randomized trial (CRT) to test the efficacy of Connect-Home ADRD, a transitional care intervention focusing on Skilled Nursing Facility (SNF) patients with Alzheimer's disease and dementias and their caregivers during transitions from SNFs to home, assisted, living, and long-term care. The primary hypothesis is that the intervention will reduce caregiver strain (Aim 1) and patient neuropsychiatric symptoms (Aim 2).","Connect-Home ADRD is a Donabedian-guided intervention that introduces new structure and processes to support Skilled Nursing Facility (SNF) staff delivery of transitional care for transitions to home, assisted living, or long-term care, and post-discharge transitional care by the Dementia Caregiving Specialist (DCS).\n\nThe research objective is to test the efficacy of Connect-Home ADRD, a transitional care intervention, targeting Skilled Nursing Facility (SNF) patients with Alzheimer's disease and related dementias (ADRD) and their primary caregivers who discharge home and other settings of care. The study will be set in 12 North Carolina SNFs and in the patient's discharge destination (during intervention periods only). Using a cluster-randomized trial design, twelve SNFs will be randomly allocated to an intervention group (N=6 SNFs) and to a control group (N=6 SNFs) by a study statistician masked to SNF identity. 360 dyads of SNF patients with ADRD and caregivers will be enrolled in 12 SNFs.",[19,20],"Alzheimer Disease","Dementia",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},360,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Connect-Home ADRD","Connect-Home ADRD will introduce new structure and processes to support SNF staff delivery of transitional care for transitions to home, assisted living, or long-term care, and post-discharge transitional care by the Dementia Caregiving Specialist.",[35],"Connect-Home ADRD Intervention",[37,41],{"measure":38,"description":39,"timeFrame":40},"Caregiver Strain","Modified Caregiver Strain Index Score (MCSI): 13 yes-no items, measure indicators of caregiver strain over the past 30 days. Summary score ranges from 0-26, higher scores indicating greater strain.","30 days after discharge from SNF",{"measure":42,"description":43,"timeFrame":40},"Patient Neuropsychiatric Symptoms","Neuropsychiatric Inventory-Q (NPI-Q): 12 items on a 3-point scale, measures presence and severity of neuropsychiatric symptoms over the past 30 days. Summary score ranges from 0-36, higher scores associated with more severe symptoms.",[45,48,51,54],{"measure":46,"description":47,"timeFrame":40},"Caregiver Depression","Patient Health Questionnaire-8 (PHQ-8): 9 items on a 4-point scale, measures depressive symptoms over the past 30 days. Scores range from 0-27, higher scores indicate more depressive symptoms.",{"measure":49,"description":50,"timeFrame":40},"Preparedness for care transitions","Care Transitions Measure-15 (CTM-15): 15 items on a 4-point scale, measures self-reported knowledge to continue care after discharge. Summary score ranges from 0-100, higher scores associated with less acute care use after discharge.",{"measure":52,"description":53,"timeFrame":40},"Patient Quality of Life","Quality of Life in Alzheimer's Disease (QoL-AD): 13 items on a 4-point scale measuring caregiver-reported quality of life in people with ADRD over the past 30 days. Summary scores range from 13-52, with higher scores indicating higher quality of life.",{"measure":55,"description":56,"timeFrame":40},"Acute Care Use","Caregiver-reported days of emergency department and hospital use in 30 days after SNF discharge.","ALL","19 Years",null,false,{"inclusion":62,"exclusion":70,"raw_text":73},[63,64,65,66,63,67,68,69],"Ability to speak English","Goal of discharge to home, assisted living, or long-term care","Diagnosis of dementia","Having a caregiver willing to participate","Legally authorized representative (LAR) who also provides support for the person with ADRD","Location within 120 miles of UNC-Chapel Hill","Admission of at least 75 SNF patients per year",[71,72],"Planned hospital readmission for procedures or treatments within 30 days post enrollment.","LAR is a court-appointed guardian.","Inclusion Criteria:\n\nPatients:\n\n* Ability to speak English\n* Goal of discharge to home, assisted living, or long-term care\n* Diagnosis of dementia\n* Having a caregiver willing to participate\n\nCaregivers:\n\n* Ability to speak English\n* Legally authorized representative (LAR) who also provides support for the person with ADRD\n\nInclusion criteria for SNFs:\n\n* Location within 120 miles of UNC-Chapel Hill\n* Admission of at least 75 SNF patients per year\n\nExclusion Criteria:\n\nPatients:\n\n* Planned hospital readmission for procedures or treatments within 30 days post enrollment.\n\nCaregivers:\n\n* LAR is a court-appointed guardian.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":97},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599","United States",[85,90,94],{"name":86,"role":87,"phone":88,"email":89},"Molly Lynch, MS","CONTACT","919-843-8874","molly_lynch@unc.edu",{"name":91,"role":87,"phone":92,"email":93},"Mark Toles, PhD, RN","9199665684","mtoles@email.unc.edu",{"name":95,"role":96},"Laura Hanson, MD","SUB_INVESTIGATOR",{"lat":98,"lon":99},35.9132,-79.05584,[101,103],{"name":86,"role":87,"phone":102,"email":89},"9198438874",{"name":104,"role":87,"phone":105,"email":106},"Kathryn Wessell, MPH","919-966-2939","kwessell@email.unc.edu",[108],{"name":91,"affiliation":13,"role":109},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114,20],"Alzheimer's Disease",[],{"nct_id":4,"found":15,"summary":117,"prompt_version":126},{"design":118,"status":119,"heading":6,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study that will involve 360 patient-caregiver pairs. Skilled nursing facilities will be randomly assigned to either receive the Connect-Home ADRD intervention or not.","completed","This study is testing an intervention called Connect-Home ADRD. This program helps staff at skilled nursing facilities (SNFs) better support patients with Alzheimer's disease and related dementias (ADRD) and their caregivers when they move from the SNF to home, assisted living, or long-term care. The study aims to see if Connect-Home ADRD can reduce the stress caregivers feel and improve neuropsychiatric symptoms (like agitation or depression) in patients 30 days after they leave the SNF. You might be able to join if you are an English-speaking patient with dementia planning to discharge from an SNF, and you have an English-speaking caregiver willing to participate. The study is currently recruiting 360 patient-caregiver pairs, but the overall status is unclear.","Caregiver strain and patient neuropsychiatric symptoms will be measured 30 days after discharge from the SNF.",118,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]