Connect-Home: Alzheimer's Disease and Related Dementias

NCT06840587 | Recruiting DMC

• 2 other identifiers: 24-27662R01NR017636-05A1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Caregiver Depression

  30 days after discharge from SNF

• Preparedness for care transitions

  30 days after discharge from SNF

• Patient Quality of Life

  30 days after discharge from SNF

• Acute Care Use

  30 days after discharge from SNF

Study Arms (2)

Connect-Home ADRD Intervention

EXPERIMENTAL

The Connect-Home ADRD Intervention will include: 1. 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. 2. 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

Standard Care - Control Group

NO INTERVENTION

Patient and caregiver dyad randomized to the control arm will receive usual SNF and post-discharge care.

Interventions

Connect-Home ADRD BEHAVIORAL

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.

Connect-Home ADRD Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients:
• Planned hospital readmission for procedures or treatments within 30 days post enrollment.
• Caregivers:
• LAR is a court-appointed guardian.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mark Toles, PhD, RN

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Lynch, MS

CONTACT

9198438874; molly_lynch@unc.edu

Kathryn Wessell, MPH

CONTACT

919-966-2939; kwessell@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Before enrollment of SNF patients and caregivers, randomization of the 12 SNFs will be conducted by blinded study staff who will use codes to conceal allocation and randomly assign SNFs in a 1:1 ratio to intervention and control arms. Study staff masked to study arm will assess outcomes, in a telephone-based interview with caregivers in both arms, 30 days after SNF discharge, this is for research purposes only. Research coordinators (RCs) will conduct 30-day electronic health record (EHR) reviews after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 9 to 36 months following publication
• 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.

Locations

US (1)