Connect-Home: Alzheimer's Disease and Related Dementias

NCT ID: NCT06840587

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Connect-Home ADRD Intervention

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.

Group Type EXPERIMENTAL

Connect-Home ADRD

Intervention Type 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.

Standard Care - Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Toles, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Molly Lynch, MS

Role: CONTACT

9198438874

Kathryn Wessell, MPH

Role: CONTACT

919-966-2939

Facility Contacts

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Molly Lynch, MS

Role: primary

919-843-8874

Mark Toles, PhD, RN

Role: backup

9199665684

Other Identifiers

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2R01NR017636-05A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-2766

Identifier Type: -

Identifier Source: org_study_id

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