Dementia Care Partner Hospital Assessment Tool

April 17, 2024 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Recruiting

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 Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Provide unpaid care to a hospitalized adult relative or partner to help them take care of themselves because of ADRD
  • 18 years or older

Exclusion Criteria:

  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Participants in this arm will only receive standard of care.
Experimental: Adjusted CHAT-AD
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.
Complete the adjusted CHAT as well as demographic and caregiving questionnaires during and after loved one's hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 72 hours post-discharge
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.
72 hours post-discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility measure: Time to complete assessments and CHAT-AD
Time Frame: Baseline
The actual amount of time taken to complete the assessments and CHAT-AD will be recorded in study records.
Baseline
Qualitative Feasibility measure: Adherence
Time Frame: 72 hours post-discharge
Participants will self-report the reasons for not having followed the CHAT-AD protocol.
72 hours post-discharge
Change in care partner burden
Time Frame: Baseline to 72 hours post-discharge
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.
Baseline to 72 hours post-discharge
Change in care partner depression
Time Frame: Baseline to 72 hours post-discharge
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.
Baseline to 72 hours post-discharge
Feasibility measure: Implementation satisfaction
Time Frame: 72 hours post-discharge
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.
72 hours post-discharge
Post-treatment Qualitative Interviews: Attrition
Time Frame: 72 hours post-discharge
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.
72 hours post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Beth Fields, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-0352
  • A176000 (Other Identifier: UW Madison)
  • EDUC/KINESIOLOGY (Other Identifier: UW Madison)
  • 1K23AG080068-01 (U.S. NIH Grant/Contract)
  • Protocol Version 12/28/2022 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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