- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05592366
Dementia Care Partner Hospital Assessment Tool
Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne Mortensen
- Phone Number: 608-262-2712
- Email: amortensen3@wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin
-
Contact:
- Anne Mortensen
- Phone Number: 608-262-2712
- Email: amortensen3@wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Beth Fields, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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