Connect-Home: Alzheimer's Disease and Related Dementias (CH-ADRD)

Transitional Care for Skilled Nursing Facility Patients With Alzheimer's Disease and Related Dementias and Their Caregivers: a Cluster Randomized Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: Connect-Home ADRD

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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Molly Lynch, MS; Phone Number: 9198438874; Email: molly_lynch@unc.edu
• Study Contact Backup: Name: Kathryn Wessell, MPH; Phone Number: 919-966-2939; Email: kwessell@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Molly Lynch, MS; Phone Number: 919-843-8874; Email: molly_lynch@unc.edu
      • Contact: Mark Toles, PhD, RN; Phone Number: 9199665684; Email: mtoles@email.unc.edu
      • Sub-Investigator: Laura Hanson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connect-Home ADRD Intervention; The Connect-Home ADRD Intervention will include: Support for SNF staff delivery of transitional care processes including a ADRD transition plan and booklet, caregiver training and engagement, and handoff of care to community providers and Dementia Caregiving Specialist.; Support for patients and caregivers provided by the Dementia Caregiving Specialist in three follow-up supportive telephone calls within 30 days of SNF discharge.	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.
No Intervention: Standard Care - Control Group; Patient and caregiver dyad randomized to the control arm will receive usual SNF and post-discharge care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	30 days after discharge from SNF

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days after discharge from SNF
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.	30 days after discharge from SNF
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.	30 days after discharge from SNF
Acute Care Use	Caregiver-reported days of emergency department and hospital use in 30 days after SNF discharge.	30 days after discharge from SNF

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Mark Toles, PhD, RN, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 24-2766; 2R01NR017636-05A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Data may be requested to achieve aims in an approved proposal if an investigator has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No