Clinical trial NCT06840587: Connect-Home: Alzheimer's Disease and Related Dementias
Official title: Transitional Care for Skilled Nursing Facility Patients With Alzheimer's Disease and Related Dementias and Their Caregivers: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-02-21
Enrollment: 360
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Caregiver Strain
timeFrame: 30 days after discharge from SNF
measure: Patient Neuropsychiatric Symptoms
timeFrame: 30 days after discharge from SNF
Secondary outcomes:
measure: Caregiver Depression
timeFrame: 30 days after discharge from SNF
measure: Preparedness for care transitions
timeFrame: 30 days after discharge from SNF
measure: Patient Quality of Life
timeFrame: 30 days after discharge from SNF
measure: Acute Care Use
timeFrame: 30 days after discharge from SNF
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mark Toles, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: