Financial HardshipAD/ADRDNCT06922188
Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia
An observational study of Financial Hardship and Alzheimer's Disease (AD), run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Financial Hardship, Alzheimer's Disease (AD), Alzheimer's Disease and Related Dementia (ADRD)
- How many people
- 2,460 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 18 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cognitive impairment precluding informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Salene MW Jones, PhD, MA, 206-667-6976, smjones3@fredhutch.org
Diana K Lowry, MPH, 206-667-7372, dlowry@fredhutch.org
About this study
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.
Read the 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.
- Conditions
- Financial Hardship, Alzheimer's Disease (AD), Alzheimer's Disease and Related Dementia (ADRD)
- Keywords
- Social Determinants of Health, Financial Toxicity, Financial Burden, Dementia, Alzheimers Disease
- Medical subject headings
- Financial Stress, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Thematic Analysis of Qualitative Interviews to Inform Measure Development
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.
Measured: Month 6 to Month 18 of the study
Internal Consistency of Financial Hardship Item Banks
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.
Measured: At initial survey administration (approximately Month 19 to month 42 of the study)
Construct Validity of Financial Hardship Item Banks
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.
Measured: At initial survey administration (approximately Month 19 to month 42 of the study)
Item-Level Performance Using Item Response Theory
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.
Measured: At initial survey administration (approximately Month 19 to month 42 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start31 Mar 2025
- Primary completion18 Sep 2029 (estimated)
- Study completion18 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Financial HardshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Johns Hopkins University, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Salene Jones, PhD, MA, Fred Hutchinson Cancer Center
- Investigators
- Salene MW Jones, PhD, MA, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922188
- Sponsor's protocol ID
- FHIRB-0020510
- Other IDs
- 1R01AG088347, RG1124668
- Acronym
- AD/ADRD
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones SMW, Gaffney A, Unger JM. Common methods of determining meaningful change in clinical practice: implications for precision patient-reported outcomes. Qual Life Res. 2023 May;32(5):1231-1238. doi: 10.1007/s11136-022-03246-4. Epub 2022 Sep 10.
PubMed 36087227Jones SMW, Du Y, Bell-Brown A, Bolt K, Unger JM. Feasibility and Validity of Asking Patients to Define Individual Levels of Meaningful Change on Patient-Reported Outcomes. J Patient Cent Res Rev. 2020 Jul 27;7(3):239-248. doi: 10.17294/2330-0698.1742. eCollection 2020 Summer.
PubMed 32760755Jones SM, Amtmann D. Health care worry is associated with worse outcomes in multiple sclerosis. Rehabil Psychol. 2014 Aug;59(3):354-9. doi: 10.1037/a0037074. Epub 2014 Jul 14.
PubMed 25019308Jones SM, Amtmann D. Differential item function analysis of a scale measuring worry about affording healthcare in multiple sclerosis. Rehabil Psychol. 2016 Nov;61(4):430-434. doi: 10.1037/rep0000105. Epub 2016 Aug 29.
PubMed 27571410Jones SMW, Walker R, Fujii M, Nekhlyudov L, Rabin BA, Chubak J. Financial difficulty, worry about affording care, and benefit finding in long-term survivors of cancer. Psychooncology. 2018 Apr;27(4):1320-1326. doi: 10.1002/pon.4677. Epub 2018 Mar 8.
PubMed 29462511Jones SM, Henrikson NB, Panattoni L, Syrjala KL, Shankaran V. A theoretical model of financial burden after cancer diagnosis. Future Oncol. 2020 Dec;16(36):3095-3105. doi: 10.2217/fon-2020-0547. Epub 2020 Sep 25.
PubMed 32976048Jones SMW, Schuler TA, Padamsee TJ, Andersen MR. Financial Anxiety is Associated With Cancer Screening Adherence in Women at High Risk of Breast Cancer. Ann Behav Med. 2021 Nov 18;55(12):1241-1245. doi: 10.1093/abm/kaab010.
PubMed 33761532Kirchhoff A, Jones S. Financial Toxicity in Adolescent and Young Adult Cancer Survivors: Proposed Directions for Future Research. J Natl Cancer Inst. 2021 Aug 2;113(8):948-950. doi: 10.1093/jnci/djab014. No abstract available.
PubMed 33839777Jones SMW, Banegas MP, Steiner JF, De Marchis EH, Gottlieb LM, Sharp AL. Association of Financial Worry and Material Financial Risk with Short-Term Ambulatory Healthcare Utilization in a Sample of Subsidized Exchange Patients. J Gen Intern Med. 2021 Jun;36(6):1561-1567. doi: 10.1007/s11606-020-06479-6. Epub 2021 Jan 19.
PubMed 33469762Jones SM, Heffner JL. Financial anxiety: a potential new target to increase smoking cessation. Future Oncol. 2022 Mar;18(9):1035-1038. doi: 10.2217/fon-2021-1570. Epub 2022 Feb 8. No abstract available.
PubMed 35132901Jones SM, Lange J, Turner J, Cherkin D, Ritenbaugh C, Hsu C, Berthoud H, Sherman K. Development and Validation of the EXPECT Questionnaire: Assessing Patient Expectations of Outcomes of Complementary and Alternative Medicine Treatments for Chronic Pain. J Altern Complement Med. 2016 Nov;22(11):936-946. doi: 10.1089/acm.2016.0242. Epub 2016 Sep 30.
PubMed 27689427Jones SMW, Du Y, Panattoni L, Henrikson NB. Assessing Worry About Affording Healthcare in a General Population Sample. Front Psychol. 2019 Nov 22;10:2622. doi: 10.3389/fpsyg.2019.02622. eCollection 2019.
PubMed 31824388Lewis CC, Wellman R, Jones SMW, Walsh-Bailey C, Thompson E, Derus A, Paolino A, Steiner J, De Marchis EH, Gottlieb LM, Sharp AL. Comparing the performance of two social risk screening tools in a vulnerable subpopulation. J Family Med Prim Care. 2020 Sep 30;9(9):5026-5034. doi: 10.4103/jfmpc.jfmpc_650_20. eCollection 2020 Sep.
PubMed 33209839Lewis CC, Jones SMW, Wellman R, Sharp AL, Gottlieb LM, Banegas MP, De Marchis E, Steiner JF. Social risks and social needs in a health insurance exchange sample: a longitudinal evaluation of utilization. BMC Health Serv Res. 2022 Nov 28;22(1):1430. doi: 10.1186/s12913-022-08740-6.
PubMed 36443789Jones SMW, Unger JM. Tailoring Pain Interference Measurement in People with Cancer: A Feasibility Study. J Pain Symptom Manage. 2022 Jul;64(1):e35-e41. doi: 10.1016/j.jpainsymman.2022.02.334. Epub 2022 Feb 27.
PubMed 35235855