NCT06922188 Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia
| NCT ID | NCT06922188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fred Hutchinson Cancer Center |
| Condition | Financial Hardship |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,460 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2029-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,460 participants in total. It began in 2025-03-31 with a primary completion date of 2029-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Salene MW Jones, PhD, MA
PRINCIPAL INVESTIGATOR
Fred Hutchinson Cancer Center
Frequently Asked Questions
Who can join the NCT06922188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Financial Hardship. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06922188 currently recruiting?
Yes, NCT06922188 is actively recruiting participants. Contact the research team at dlowry@fredhutch.org for enrollment information.
Where is the NCT06922188 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06922188 clinical trial?
NCT06922188 is sponsored by Fred Hutchinson Cancer Center. The principal investigator is Salene MW Jones, PhD, MA at Fred Hutchinson Cancer Center. The trial plans to enroll 2,460 participants.