Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia (AD/ADRD)

February 18, 2026 updated by: Salene Jones, PhD, MA, Fred Hutchinson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study investigates the financial hardship experienced by individuals with Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) and their caregivers. The research comprises qualitative interviews, content validation surveys, and quantitative data collection to assess financial stressors, caregiving costs, and coping mechanisms.

The first phase involves conducting semi-structured interviews with individuals diagnosed with AD/ADRD and their caregivers. These interviews will be conducted virtually, by phone, or in person, with most expected to take place remotely. Informed consent will be obtained either verbally or through signed documentation, as appropriate. Participants will be interviewed separately to ensure privacy, particularly in cases where both the patient and their caregiver are involved. The interview guide will explore changes in financial circumstances before and after diagnosis, general and specific aspects of financial hardship-including financial stress, financial strain, and asset depletion-contributing factors to financial hardship, strategies used to mitigate financial burdens, and the impact of financial hardship on well-being, decision-making, and care options. Additionally, the study will examine financial management practices, including the transition of financial responsibility from the patient to caregivers, as well as the role of caregivers and social networks in financial management and hardship buffering. Interviews will be recorded and transcribed, with Spanish transcripts translated into English. Participants will receive a small incentive for participation. If a caregiver or patient expresses interest in the other member of the dyad participating, they will be contacted via email or phone for potential enrollment.

Following the qualitative phase, a structured survey will be distributed to validate the relevance and applicability of financial hardship indicators identified during the interviews. Participants will receive an email with a study invitation and a survey link, where they will review definitions of financial hardship domains, assess the relevance of each survey item based on the perspective of the caregiver and patient, and provide demographic and job-related information. To optimize participant burden, randomized subsets of the survey will be assigned if the item bank is extensive. Participants will receive a small incentive for survey completion.

After eligibility screening, participants will complete a financial hardship survey either online or via mail. Online participants will review an electronic consent statement before proceeding, while mail-in participants will sign and return a consent form along with their completed survey using a prepaid return envelope. The survey will collect data on financial stressors, caregiving costs, and coping mechanisms. Participants will receive informational handouts on financial support resources and mental health care services. The study will examine financial caregiving networks and social support structures, as well as how financial hardship influences long-term care decisions and overall well-being. Participants will be compensated for their time and contribution to the study.

Quality control and data management processes will ensure the integrity and accuracy of study data. Surveys and interview transcripts will undergo validation checks to ensure data consistency. Data will be categorized using structured coding frameworks. A mixed-methods approach will be employed for analysis, using qualitative thematic analysis for interview data and statistical modeling for survey responses.

This study aims to improve the understanding of financial hardship among individuals with AD/ADRD and their caregivers, providing critical insights to inform policy interventions and support strategies for affected individuals and their families.

Study Type

Observational

Enrollment (Estimated)

2460

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 Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salene MW Jones, PhD, MA

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population includes individuals with Alzheimer's Disease or Related Dementias (AD/ADRD) and financial caregivers providing financial support for AD/ADRD patients.

Description

Inclusion Criteria:

  • Adults aged 18 years or older

  • One of the following:

    • Clinical diagnosis of Alzheimer's disease or related dementia
    • Being a caregiver to individuals with clinical diagnosis of Alzheimer's disease or related dementia
  • Able to read and speak English or Spanish
  • Able to provide informed consent
  • Residing in the United States

Exclusion Criteria:

• Cognitive impairment precluding informed consent

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

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thematic Analysis of Qualitative Interviews to Inform Measure Development
Time Frame: Month 6 to Month 18 of the study
Qualitative interviews with patients and caregivers will be conducted and analyzed using a framework analysis approach. Interview data will be used to refine our conceptual model of financial hardship (Jones et. al 2024). The unit of measure will be the number of major thematic categories identified through qualitative analysis and the number of conceptual domains established in the finalized model.
Month 6 to Month 18 of the study
Internal Consistency of Financial Hardship Item Banks
Time Frame: At initial survey administration (approximately Month 19 to month 42 of the study)
Internal consistency of the financial hardship item banks will be evaluated using Cronbach's alpha for each domain. The unit of measure will be the alpha coefficient (range 0-1), with higher values indicating greater internal consistency.
At initial survey administration (approximately Month 19 to month 42 of the study)
Construct Validity of Financial Hardship Item Banks
Time Frame: At initial survey administration (approximately Month 19 to month 42 of the study)
Construct validity will be assessed by examining correlations between financial hardship scores and related constructs, such as quality of life, stress, and social connectedness. The unit of measure will be Pearson or Spearman correlation coefficients (range -1 to 1). The direction and strength of these correlations will be used to evaluate convergent validity.
At initial survey administration (approximately Month 19 to month 42 of the study)
Item-Level Performance Using Item Response Theory
Time Frame: At initial survey administration (approximately Month 19 to month 42 of the study)
Item-level performance for each financial hardship item bank will be assessed using item response theory (IRT) modeling. The unit of measure will be the discrimination (slope) and severity (threshold) parameters, reported for each item individually.
At initial survey administration (approximately Month 19 to month 42 of the study)

Collaborators and Investigators

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

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Johns Hopkins University
National Institute on Aging (NIA)
University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Salene MW Jones, PhD, MA, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

March 31, 2025

Primary Completion (Estimated)

September 18, 2029

Study Completion (Estimated)

December 18, 2029

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHIRB-0020510
  • 1R01AG088347 (U.S. NIH Grant/Contract)
  • RG1124668 (Other Identifier: Fred Hutchinson Cancer Center)

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

product manufactured in and exported from the U.S.

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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