Connect-Home: Alzheimer's Disease and Related Dementias

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Dementia

• Registration Number: NCT06840587
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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).

Detailed Description

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).

The 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.

Study Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Status Verified: 2025-04
• Study Start: 2025-04-04
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Patients:

• Ability to speak English
• Goal of discharge to home, assisted living, or long-term care
• Diagnosis of dementia
• Having a caregiver willing to participate

Caregivers:

• Ability to speak English
• Legally authorized representative (LAR) who also provides support for the person with ADRD

Inclusion criteria for SNFs:

• Location within 120 miles of UNC-Chapel Hill
• Admission of at least 75 SNF patients per year

Exclusion Criteria

Patients:

• Planned hospital readmission for procedures or treatments within 30 days post enrollment.

Caregivers:

• LAR is a court-appointed guardian.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Caregiver Strain	30 days after discharge from SNF	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.
Patient Neuropsychiatric Symptoms	30 days after discharge from SNF	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.

Secondary Outcome Measures

Name	Time	Method
Caregiver Depression	30 days after discharge from SNF	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.
Preparedness for care transitions	30 days after discharge from SNF	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.
Patient Quality of Life	30 days after discharge from SNF	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.
Acute Care Use	30 days after discharge from SNF	Caregiver-reported days of emergency department and hospital use in 30 days after SNF discharge.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States