Alzheimer DiseaseCH-ADRDNCT06840587
Connect-Home: Alzheimer's Disease and Related Dementias
A study testing Connect-Home ADRD in people with Alzheimer Disease and Dementia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Connect-Home ADRD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- Patients:
- Planned hospital readmission for procedures or treatments within 30 days post enrollment.
- Caregivers:
- LAR is a court-appointed guardian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Molly Lynch, MS, 919-843-8874, molly_lynch@unc.edu
Mark Toles, PhD, RN, 9199665684, mtoles@email.unc.edu
About this study
Official title: 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).
Read the 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.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Connect-Home ADRD
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect-Home ADRDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days after discharge from SNF
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 30 days after discharge from SNF
Acute Care Use
Caregiver-reported days of emergency department and hospital use in 30 days after SNF discharge.
Measured: 30 days after discharge from SNF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start4 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Mark Toles, PhD, RN, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840587
- Sponsor's protocol ID
- 24-2766
- Other IDs
- 2R01NR017636-05A1
- Acronym
- CH-ADRD
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Care for Skilled Nursing Facility Patients With Alzheimer's Disease and Related Dementias and Their Caregivers: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06840587
- Acronym / sponsor ID
- CH-ADRD / 24-2766
- Conditions
- Alzheimer Disease, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connect-Home ADRD Intervention | Experimental | Behavioral: Connect-Home ADRDThe 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. |
| Standard Care - Control Group | No intervention | –Patient and caregiver dyad randomized to the control arm will receive usual SNF and post-discharge care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to speak English
- Goal of discharge to home, assisted living, or long-term care
- Diagnosis of dementia
- Having a caregiver willing to participate
- Ability to speak English
Key exclusion criteria (4 listed)
- Planned hospital readmission for procedures or treatments within 30 days post enrollment.
- LAR is a court-appointed guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connect-Home ADRDConnect-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. | Behavioural | Connect-Home ADRD Intervention |
Primary outcome
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.
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.
4 secondary outcomes
Caregiver Depression
Time frame: 30 days after discharge from SNF
Preparedness for care transitions
Time frame: 30 days after discharge from SNF
Patient Quality of Life
Time frame: 30 days after discharge from SNF
Acute Care Use
Time frame: 30 days after discharge from SNF
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Toles, PhD, RN principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect-Home ADRD in people with Alzheimer Disease and Dementia, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Lynch, MS (9198438874, molly_lynch@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Strain (time frame: 30 days after discharge from SNF). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.