Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06922188
Status
Recruiting
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Conditions

  • Alzheimer's Disease (AD)
  • Alzheimer's Disease and Related Dementia (ADRD)
  • Financial Hardship

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

Alzheimer's Disease and related dementias (AD/ADRD) are common and debilitating conditions. Financial hardship, a multidimensional construct of financial strain, financial stress and asset depletion, is common in AD/ADRD due to exorbitant out-of-pocket spending such as for long-term care, lower work productivity and income for their caregivers that can last for decades after disease onset, and difficulty deciding between nursing home care or home-based care while negotiating insurance coverage. People from historically marginalized groups can experience a double disparity with fewer financial resources to manage AD/ADRD and a greater risk of AD/ADRD. Screening for financial hardship in AD/ADRD is key for addressing the needs of patients and caregivers but critical barriers include a lack of suitable screening measures. Current measures are very general and meant for people without chronic medical conditions or are specific to other diseases. To fill this gap, this study will create a suite of measures that can screen for financial hardship in people with AD/ADRD and their families and caregivers. The measures will include a set to assess caregiver burden; a set to assess patient hardship as reported by the caregiver for patients who cannot report for themselves; and a set of patient-reported measures for patients that are able to report for themselves. To create these financial hardship screening measures, the project will conduct the following aims. Aim 1- Develop financial hardship screening measures for Alzheimer's Disease and related dementias: Using interviews with both caregivers and people with AD/ADRD, key indicators of financial hardship that are unique to AD/ADRD and the point in the lifespan in which it occurs will be identified. The ways that social and caregiver network size affect financial hardship will also be explored. Using the interviews and previous measures, preliminary measures will be created and will be reviewed by experts and a patient and caregiver advisory board. Aim 2- Create item response theory-based screening measures for financial hardship measures in Alzheimer's Disease and related dementias: Large samples of people with AD/ADRD (n=1000) and caregivers (n=1000) will be surveyed and item response theory will be used to evaluate and revise the measures and create scoring algorithms. A sample of additional caregivers matched to primary caregivers (n=400) will also be recruited to evaluate interrater reliability of the measures. Aim 3- Evaluate the financial hardship measures across patient and caregiver populations: Using the sample from Aim 2 and item response theory, we will evaluate the financial hardship screening measures across the following groups to ensure they are unbiased and reflect true differences: race/ethnicity; patient comorbidities; stage of AD/ADRD; caregiver relationship; social network size; number of caregivers; financial support provided; and caregiver's own health status (disability, comorbidities). The resulting measures will improve identification of financial hardship in AD/ADRD.

Key Dates

Start date
Mar 31, 2025
Status verified
Feb 2026
Primary completion
Sep 18, 2029
Completion
Dec 18, 2029

Study Design

Enrollment
2,460 participants (estimated)

Arms

  • Arm: Alzheimer's Disease and Related Dementias (ADRD) Financial Burden Cohort
    The cohort consists of patients diagnosed with Alzheimer's Disease (AD) and related dementias (ADRD). Participants are identified based on clinical diagnostic criteria, including cognitive assessments. This study examines the financial burden associated with AD/ADRD from the patient's perspective.
  • Arm: Caregivers of Patients with Alzheimer's Disease and Related Dementias (ADRD) Financial Burden Cohort
    This cohort consists of caregivers providing care for patients diagnosed with Alzheimer's Disease (AD) and related dementias (ADRD). Caregivers may be family members, or friends who assist with financial management and other tasks such as daily activities, medical management, and decision-making. This study evaluates the financial burden experienced by caregivers of individuals with AD/ADRD.

Primary Outcome Measure

Thematic Analysis of Qualitative Interviews to Inform Measure Development [ Time Frame: Month 6 to Month 18 of the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer CenterSeattleWashington98109
Salene MW Jones, PhD, MA
[email protected]
206-667-6976
Diana K Lowry, MPH
[email protected]
206-667-7372
Salene MW Jones, PhD, MA (PRINCIPAL_INVESTIGATOR)

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Fred Hutchinson Cancer Center· Seattle, WA

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