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

NCT06922188 | Recruiting

• 3 other identifiers: FHIRB-00205101R01AG088347RG1124668
• Study Type: observational
• Target: 2,460
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  At initial survey administration (approximately Month 19 to month 42 of the study)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment precluding informed consent

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Institute on Aging (NIA): collaborator
• Johns Hopkins University: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Related Publications (19)

• 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.

  PMID: 36087227 BACKGROUND

• Jones 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.

  PMID: 32760755 BACKGROUND

• Jones 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.

  PMID: 25019308 BACKGROUND

• Jones 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.

  PMID: 27571410 BACKGROUND

• Jones 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.

  PMID: 29462511 BACKGROUND

• Jones 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.

  PMID: 32976048 BACKGROUND

• Jones 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.

  PMID: 33761532 BACKGROUND

• Kirchhoff 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.

  PMID: 33839777 BACKGROUND

• Jones 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.

  PMID: 33469762 BACKGROUND

• Jones 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.

  PMID: 35132901 BACKGROUND

• Jones 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.

  PMID: 27689427 BACKGROUND

• Jones 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.

  PMID: 31824388 BACKGROUND

• Lewis 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.

  PMID: 33209839 BACKGROUND

• Lewis 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.

  PMID: 36443789 BACKGROUND

• Jones 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.

  PMID: 35235855 BACKGROUND

• Jones SMW, Ton M, Malen RC, Newcomb PA, Heffner JL. Item response theory analysis of benefits and harms of cannabis use in cancer survivors. J Natl Cancer Inst Monogr. 2024 Aug 15;2024(66):275-281. doi: 10.1093/jncimonographs/lgad022.

  PMID: 39108240 BACKGROUND

• Noel PH, Jones S, Parchman ML. Patient Experience in an Era of Primary Care Transformation: Revisiting the PACIC. Eur J Pers Cent Healthc. 2016;4(3):528-540.

  PMID: 27746917 BACKGROUND

• Jones SMW, Yi JC, Jim HSL, Loren AW, Majhail NS, Uberti J, Whalen V, Leisenring WM, Flowers MED, Lee SJ, Syrjala KL. Age and gender differences in financial distress among hematopoietic cell transplant survivors. Support Care Cancer. 2020 Sep;28(9):4361-4371. doi: 10.1007/s00520-019-05291-1. Epub 2020 Jan 8.

  PMID: 31916007 BACKGROUND

• Jones SM, Yi J, Henrikson NB, Panattoni L, Shankaran V. Financial hardship after cancer: revision of a conceptual model and development of patient-reported outcome measures. Future Sci OA. 2024 May 14;10(1):FSO983. doi: 10.2144/fsoa-2023-0229. eCollection 2024.

  PMID: 38827796 BACKGROUND

Related Links

• Research Portfolio Online Reporting Tools

MeSH Terms

Conditions

Financial Stress; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Salene MW Jones, PhD, MA

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana K Lowry, MPH

CONTACT

206-667-7372; dlowry@fredhutch.org

Salene Jones, PhD, MA

CONTACT

206-667-6976; smjones3@fredhutch.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 10, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 18, 2029
• Study Completion (Estimated): December 18, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)