Alzheimer DiseaseNCT05592366
Dementia Care Partner Hospital Assessment Tool
A study testing Care Partner Hospital Assessment Tool in people with Alzheimer Disease and Dementia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to see whether an adapted questionnaire called the Care Partner Hospital Assessment Tool (CHAT) for care partners of hospitalized patients living with Alzheimer's disease and related dementias (ADRD) (CHAT-AD) can help people with dementia receive better care after they go home from the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Care Partner Hospital Assessment Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2024to May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of ADRD
- 18 years or older
Who cannot join
- Non-English speaking
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 Wisconsin
Madison, Wisconsin, 53705
Anne Mortensen, 608-262-2712, amortensen3@wisc.edu
About this study
Official title: Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care
The purpose of this study is to see whether an adapted questionnaire called the Care Partner Hospital Assessment Tool (CHAT) for care partners of hospitalized patients living with Alzheimer's disease and related dementias (ADRD) (CHAT-AD) can help people with dementia receive better care after they go home from the hospital. Participants will be a care partner ('family member or friend') who provides unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of dementia. Participants can expect to be in this study for 14 days.
Read the detailed description
The purpose of this study is to adapt CHAT for care partners of hospitalized patients living with ADRD (CHAT-AD) and evaluate its feasibility and potential efficacy in a pilot randomized clinical trial. Findings from this study will enable the lead researcher to launch an independent program of research that aims to (1) improve hospital-based care processes and outcomes for patients living with ADRD and their care partners, and (2) make clear the essential caregiving role that so many care partners of patients living with ADRD assume.
In order to adapt CHAT, there will be two design teams with key stakeholders from local aging networks and a large academic medical system: one team comprised of previously hospitalized patients living with ADRD and their care partners (N=7 dyads) and the second comprised of healthcare system administrators and clinicians (N=7). The team will use a validated participatory human-centered design process in which each team completes 5 co-design videoconference sessions that occur in parallel across 4 months, with 2-3 weeks between each session.
Upon adaptation of the CHAT-AD, the study team will partner with a medical and surgical units that are part of a large academic medical system to recruit 128 eligible care partners of hospitalized patients living with ADRD, randomized into either the CHAT-AD plus usual care or usual care-only groups. The team will assess feasibility by examining overall recruitment, attrition, safety, adherence, and implementation satisfaction. To examine efficacy, a validated measure of caregiving preparedness will be obtained pre- and post-intervention.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Care Partner Hospital Assessment Tool
- 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.
Care Partner Hospital Assessment ToolBehavioural
Complete the adjusted CHAT as well as demographic and caregiving questionnaires during and after loved one's hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants in this arm will only receive standard of care. |
| Adjusted CHAT-AD | Experimental | Using CHAT, participants will be asked questions about their needs to fully support and care for their loved one after the loved one is released from the hospital. Receives: Behavioral: Care Partner Hospital Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preparedness for Caregiving
Using the Preparedness for Caregiving Scale, which is a self-rated assessment that consists of eight items that asks care partners how well prepared they believe they are for multiple domains of caregiving, change in preparedness will be measured. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the care partner feels for caregiving.
Measured: Baseline to 72 hours post-discharge
Care partner satisfaction of care
The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a 29-item survey that asks discharged patients about their recent hospital stay. The study team will modify and use three items from this survey to capture care partner satisfaction of care. These items are rated on a 4-point case from 1 (definitely no or strongly disagree) to 4 (definitely yes or strongly agree), with higher scores representing more care partner satisfaction with care.
Measured: 72 hours post-discharge
Secondary outcomes (6)
Feasibility measure: Time to complete assessments and CHAT-AD
The actual amount of time taken to complete the assessments and CHAT-AD will be recorded in study records.
Measured: Baseline
Qualitative Feasibility measure: Adherence
Participants will self-report the reasons for not having followed the CHAT-AD protocol.
Measured: 72 hours post-discharge
Change in care partner burden
The Zarit Burden Interview is a self-rated assessment that consists of 22 items that asks care partners about their burden related to the care they provide a relative. Responses are rated on a 5-point scale with scores ranging from 0 (never) to 4 (nearly always). The Zarit Burden Interview score is obtained by adding the score for each question (total points). The higher the score the more burden the care partner feels.
Measured: Baseline to 72 hours post-discharge
Change in care partner depression
The Patient Health Questionnaire-2 (PHQ-2) is a self-rated assessments that consists of 2 items that asks care partners about the frequency of depressed mood and anhedonia over the past two weeks. Responses are rated on a 4-point scale with scores ranging from 0 (not at all) to 3 (nearly every day). The PHQ-2 score is obtained by adding the score for each question (total points). The higher the score the more depressed the care partner feels. A score of 3 can be used as the cutpoint when screening for depression.
Measured: Baseline to 72 hours post-discharge
Feasibility measure: Implementation satisfaction
Clinician questionnaire composed of 5 Likert questions (scale of 1-5) as well as open-ended questions. A higher number on the Likert scale indicates higher satisfaction.
Measured: 72 hours post-discharge
Post-treatment Qualitative Interviews: Attrition
Qualitative analysis will proceed concurrently with data collection to allow identified themes related to attrition to be explored in subsequent interviews. All team members will analyze the data and look for themes and trends that are emergent from the data.
Measured: 72 hours post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start2 Apr 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Beth Fields, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592366
- Sponsor's protocol ID
- 2022-0352
- Other IDs
- A176000, EDUC/KINESIOLOGY, Protocol Version 10/29/2024, 1K23AG080068-01
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fields B, Werner N, Shah MN, Hetzel S, Golden BP, Gilmore-Bykovskyi A, Farrar Edwards D. Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care: Protocol for a 2 Sequential Phase Study. JMIR Res Protoc. 2023 Jun 22;12:e46808. doi: 10.2196/46808.
PubMed 37347517
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care
- ClinicalTrials.gov ID
- NCT05592366
- Acronym / sponsor ID
- 2022-0352
- Conditions
- Alzheimer Disease, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Oct 2022 (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.
The purpose of this study is to see whether an adapted questionnaire called the Care Partner Hospital Assessment Tool (CHAT) for care partners of hospitalized patients living with Alzheimer's disease and related dementias (ADRD) (CHAT-AD) can help people with dementia receive better care after they go home from the hospital. Participants will be a care partner ('family member or friend') who provides unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of dementia. Participants can expect to be in this study for 14 days.
Detailed description
The purpose of this study is to adapt CHAT for care partners of hospitalized patients living with ADRD (CHAT-AD) and evaluate its feasibility and potential efficacy in a pilot randomized clinical trial. Findings from this study will enable the lead researcher to launch an independent program of research that aims to (1) improve hospital-based care processes and outcomes for patients living with ADRD and their care partners, and (2) make clear the essential caregiving role that so many care partners of patients living with ADRD assume.
In order to adapt CHAT, there will be two design teams with key stakeholders from local aging networks and a large academic medical system: one team comprised of previously hospitalized patients living with ADRD and their care partners (N=7 dyads) and the second comprised of healthcare system administrators and clinicians (N=7). The team will use a validated participatory human-centered design process in which each team completes 5 co-design videoconference sessions that occur in parallel across 4 months, with 2-3 weeks between each session.
Upon adaptation of the CHAT-AD, the study team will partner with a medical and surgical units that are part of a large academic medical system to recruit 128 eligible care partners of hospitalized patients living with ADRD, randomized into either the CHAT-AD plus usual care or usual care-only groups. The team will assess feasibility by examining overall recruitment, attrition, safety, adherence, and implementation satisfaction. To examine efficacy, a validated measure of caregiving preparedness will be obtained pre- and post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants in this arm will only receive standard of care. |
| Adjusted CHAT-AD | Experimental | Behavioral: Care Partner Hospital Assessment ToolUsing CHAT, participants will be asked questions about their needs to fully support and care for their loved one after the loved one is released from the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provide unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of ADRD
- 18 years or older
Key exclusion criteria (1 listed)
- Non-English speaking
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 |
|---|---|---|
| Care Partner Hospital Assessment ToolComplete the adjusted CHAT as well as demographic and caregiving questionnaires during and after loved one's hospitalization. | Behavioural | Adjusted CHAT-AD |
Primary outcome
Change in Preparedness for Caregiving
Time frame: Baseline to 72 hours post-discharge
Using the Preparedness for Caregiving Scale, which is a self-rated assessment that consists of eight items that asks care partners how well prepared they believe they are for multiple domains of caregiving, change in preparedness will be measured. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the care partner feels for caregiving.
Care partner satisfaction of care
Time frame: 72 hours post-discharge
The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) is a 29-item survey that asks discharged patients about their recent hospital stay. The study team will modify and use three items from this survey to capture care partner satisfaction of care. These items are rated on a 4-point case from 1 (definitely no or strongly disagree) to 4 (definitely yes or strongly agree), with higher scores representing more care partner satisfaction with care.
6 secondary outcomes
Feasibility measure: Time to complete assessments and CHAT-AD
Time frame: Baseline
Qualitative Feasibility measure: Adherence
Time frame: 72 hours post-discharge
Change in care partner burden
Time frame: Baseline to 72 hours post-discharge
Change in care partner depression
Time frame: Baseline to 72 hours post-discharge
Feasibility measure: Implementation satisfaction
Time frame: 72 hours post-discharge
Post-treatment Qualitative Interviews: Attrition
Time frame: 72 hours post-discharge
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 14 Aug 2026.
- Derived from this study: PubMed 37347517Fields B, Werner N, Shah MN, Hetzel S, Golden BP, Gilmore-Bykovskyi A, Farrar Edwards D. Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care: Protocol for a 2 Sequential Phase Study. JMIR Res Protoc. 2023 Jun 22;12:e46808. doi: 10.2196/46808.
- Individual participant dataSharing planned: No
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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.
Beth Fields, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Partner Hospital Assessment Tool in people with Alzheimer Disease and Dementia, run by University of Wisconsin, Madison 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 2 inclusion and 1 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 14 Aug 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 Anne Mortensen (608-262-2712, amortensen3@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Preparedness for Caregiving (time frame: Baseline to 72 hours post-discharge). 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?
On the ClinicalTrials.gov record for NCT05592366, which also lists 1 linked publication.
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 14 Aug 2026.