Dementia Care Partner Hospital Assessment Tool
Primary Purpose
Alzheimer Disease, Dementia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Partner Hospital Assessment Tool
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Adjusted CHAT-AD
Arm Description
Participants in this arm will only receive standard of care.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Qualitative Feasibility measure: Adherence
Participants will self-report the reasons for not having followed the CHAT-AD protocol.
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.
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.
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.
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.
Full Information
NCT ID
NCT05592366
First Posted
October 19, 2022
Last Updated
October 20, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05592366
Brief Title
Dementia Care Partner Hospital Assessment Tool
Official Title
Adapting and Testing the Care Partner Hospital Assessment Tool for Use in Dementia Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2024 (Anticipated)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants in this arm will only receive standard of care.
Arm Title
Adjusted CHAT-AD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Care Partner Hospital Assessment Tool
Intervention Description
Complete the adjusted CHAT as well as demographic and caregiving questionnaires during and after loved one's hospitalization.
Primary Outcome Measure Information:
Title
Change in Preparedness for Caregiving
Description
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.
Time Frame
Baseline to 72 hours post-discharge
Title
Care partner satisfaction of care
Description
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.
Time Frame
72 hours post-discharge
Secondary Outcome Measure Information:
Title
Feasibility measure: Time to complete assessments and CHAT-AD
Description
The actual amount of time taken to complete the assessments and CHAT-AD will be recorded in study records.
Time Frame
Baseline
Title
Qualitative Feasibility measure: Adherence
Description
Participants will self-report the reasons for not having followed the CHAT-AD protocol.
Time Frame
72 hours post-discharge
Title
Change in care partner burden
Description
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.
Time Frame
Baseline to 72 hours post-discharge
Title
Change in care partner depression
Description
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.
Time Frame
Baseline to 72 hours post-discharge
Title
Feasibility measure: Implementation satisfaction
Description
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.
Time Frame
72 hours post-discharge
Title
Post-treatment Qualitative Interviews: Attrition
Description
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.
Time Frame
72 hours post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Mortensen
Phone
608-262-2712
Email
amortensen3@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Fields, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Mortensen
Phone
608-262-2712
Email
amortensen3@wisc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Dementia Care Partner Hospital Assessment Tool
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