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NCT Number: NCT06840587

Connect-Home: Alzheimer's Disease and Related Dementias

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).

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Caregiver Strain

    Time frame: 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.

  2. Patient Neuropsychiatric Symptoms

    Time frame: 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 outcomes

  1. Caregiver Depression

    Time frame: 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.

  2. Preparedness for care transitions

    Time frame: 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.

  3. Patient Quality of Life

    Time frame: 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.

  4. Acute Care Use

    Time frame: 30 days after discharge from SNF

    Caregiver-reported days of emergency department and hospital use in 30 days after SNF discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn Wessell, MPH

CONTACT

[email protected]

919-966-2939

Molly Lynch, MS

CONTACT

[email protected]

9198438874

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: CH-ADRD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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