Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia
Conditions: Financial Hardship, Alzheimer&#39;s Disease (AD), Alzheimer&#39;s Disease and Related Dementia (ADRD)
Sponsor: Fred Hutchinson Cancer Center

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Development of Measures to Screen for Financial 
Hardship in Alzheimer's Disease and Dementia
PROTOCOL Version 2.0
Conducted by Investigators at Fred Hutchinson Cancer Center 
and participating accrual sites. 
Dates of Study:  08-01-24 to 07-31-2029
Principal Investigator
Salene MW Jones, PhD, MA
Fred Hutchinson Cancer Center
1100 Fairview Ave. North, M4-B402
Seattle, WA  98109
(206) 667-6976
Fred Hutch Collaborators
Laura Panattoni, PhD
Partnering Institutions 
Erin Kent, PhD, University of North Carolina
Laura Samuel, PhD and Katherine Ornstein, PhD
Johns Hopkins University
Funding Agency Collaborators
Fred Hutch IRB
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Table of Contents
Study Summary ...............................................................................................................................3
Background/Significance.................................................................................................................3
Objectives ........................................................................................................................................6
Subject Population and Inclusion/Exclusion Criteria......................................................................6
Recruitment Methods.......................................................................................................................7
The Consent Process........................................................................................................................9
Study Procedures ...........................................................................................................................10
Endpoints and Measures................................................................................................................10
Statistics and Rationale for Number of Subjects ...........................................................................11
Risks and Benefits .........................................................................................................................16
Data Management and Confidentiality..........................................................................................16
Use of Data ....................................................................................................................................17
Provisions to Monitor Data and Protect Privacy ...........................................................................17
Qualifications to Conduct Research and Resources Available......................................................17
Study Timeline ..............................................................................................................................18
Appendix 1: Consent Forms ..........................................................................................................18
Appendix 2: Interview Guide ........................................................................................................18
Appendix 3: Measures (Survey) ....................................................................................................18
Appendix 4: Recruitment Materials and Screening Scripts...........................................................18
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Study 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.
Background/Significance 
Alzheimer’s Disease and related dementias (AD/ADRD) are common and debilitating 
conditions, with an overall prevalence rate between 10% and 15% and an annual incidence rate of 
2.3%.1,2,20 While the primary symptoms of AD/ADRD are cognitive changes, functional decline and 
behavioral symptoms, an additional important sequela is financial hardship given several challenges 
that arise with AD/ADRD. These challenges include exorbitant out-of-pocket spending such as for 
long-term care,21 lower work productivity and income for their caregivers that can last for decades 
after disease onset,22,23 and difficulty deciding between nursing home care or home-based care while 
negotiating insurance coverage.24,25 Financial hardship is a multidimensional construct consisting of 
financial strain, financial stress and asset depletion.3-5 Financial strain is the lack of ability to afford 
and difficulty affording living costs. Financial stress is experienced as worry and distress about 
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finances that affect functioning. Asset depletion occurs when the caregiver and their recipient drain 
resources such as savings accounts and durable assets and these assets may include drawing support 
from additional family members or friends. Caregivers of people with AD/ADRD often manage 
finances for the patient and experience financial hardship themselves through employment 
disruption, difficulty caring for their own health and incurring debt to help pay for the patient’s 
healthcare and living costs. This can lead to financial hardship for both the person with AD/ADRD 
and their caregivers.
Financial hardship in AD/ADRD can be particularly challenging for people from historically 
marginalized groups, such as racial and ethnic minoritized groups and those with disabilities, and 
may exacerbate chronic financial strain.6 As outlined in the National Institute on Aging’s Health 
Disparities Framework and the World Health Organization’s Social Determinants of Health 
Framework, fundamental factors such as race, ethnicity and disability status can predispose people 
to financial hardship due to institutional/structural racism, discrimination and lack of appropriate 
supports.6,26,27 As examples, the poverty rate is two or three times28,29 higher comparing either those 
with disabilities to those without or comparing those who are Black, Hispanic or Native American to 
those who are white and those who are Black have about one-tenth of the household wealth of those 
who are white.30 People with AD/ADRD who are Black or Hispanic are also more likely to live with 
their adult children than people who are White and the adult children tend to provide caregiving.31 
Importantly, these structural inequities create a double disparity with regard to AD/ADRD among 
those with limited financial resources; they are more likely to develop AD/ADRD but also have 
fewer resources to address AD/ADRD-related financial hardship.32-37 These health inequities 
highlight the need to ensure marginalized groups who experience AD/ADRD-related financial 
hardship are identified and provided appropriate financial aid.
Currently, suitable screening measures to identify financial hardship in AD/ADRD do not 
exist and this represents a critical barrier to addressing financial hardship and associated health 
inequities. Screening for financial hardship is a key part of health equity to ensure each patient and 
their family receive what they need to be as healthy as possible and many healthcare regulatory 
agencies are requiring some form of financial hardship screening.38-41 Many well validated general 
measures of financial hardship exist7-13,42,43 as do some for specific clinical populations.14-16 
However, these measures do not capture several unique aspects of AD/ADRD-related financial 
hardship. Financial management is often transferred to caregivers for people with AD/ADRD and 
this dynamic process is rarely captured in current financial hardship measures. Another unique 
aspect of financial hardship in AD/ADRD is the size and complexity of a patient’s network of 
caregivers involved in handling finances and paying bills. 
Receiving 
financial 
support 
from 
family or 
friends 
may 
buffer 
against 
financial 
hardship 
but 
most non-
AD/ADRD measures do not account for level of financial support and larger social networks are not 
Table 1: Measures that will be created as part of the proposed project
Set of 
Item 
banks
Person 
completing 
the measures
Person’s financial 
health being 
assessed
Financial Hardship Domains
1
Caregiver(s)
Caregiver
Financial stress; Financial 
strain; Asset depletion
2
Caregiver(s)
Person with 
AD/ADRD
Financial stress; Financial 
strain; Asset depletion
3
Person with 
AD/ADRD
Person with 
AD/ADRD
Financial function; Financial 
stress; Financial strain; Asset 
depletion
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necessarily protective.44 Screening measures for each dimension of financial hardship are needed as 
some people with AD/ADRD and their caregivers may be able to cope but still experience financial 
stress and difficulty affording living costs.45 The out-of-pocket costs from AD/ADRD can be high 
and long lasting, particularly due to the need to pay for in-home care to help manage daily activities 
and the need for the patient and caregiver to leave the labor force without the ability to return. 
Current financial hardship screening measures would also present several logistical 
challenges for screening people with AD/ADRD and their caregivers for financial hardship. Many 
screeners are long (20+ items), putting an unnecessary burden on caregivers and patients and 
making clinic administration infeasible. Most current measures are also designed to be answered by 
the patient and have not been validated for use by caregivers to report on the patient’s financial 
hardship. While patients with mild AD/ADRD might be able to report their own financial hardship, 
there is a persistent need for caregiver-reported measures of financial hardship for those with more 
severe disease as the caregiver and family members could report for the patient and are likely to 
experience hardship themselves.
Current Project
In response to RFA-AG-24-036 (“Measuring Financial Hardship Among People and 
Families Living with AD/ADRD”), the project will develop a measurement system that can screen 
for financial hardship in AD/ADRD across illness stages and variation in family involvement in 
care. The first measure will be a patient-reported measure of financial function, defined as how 
actively a patient is managing their finances. This also includes who may be managing finances for 
the patient. The next group of measures will include two sets of caregiver-reported outcome 
measures and one set of patient-reported measures to assess and screen for the three dimensions of 
financial hardship in AD/ADRD (Table 1). The financial function measure will help clinics identify 
whether the patient (set 3) or caregiver (set 2) should complete the financial hardship screening 
measure for the patient. The first set of caregiver-reported measures will assess the caregiver’s own 
financial health as reported by the caregiver (set 1) and will be usable with multiple caregivers to 
capture financial hardship across members of families experiencing AD/ADRD. These measures 
will help identify caregivers who are themselves experiencing financial hardship and need extra 
support. The second set of caregiver-reported measures will assess the patient’s financial health as 
reported by the caregiver (set 2). The second set of measures are often called observer-reported or 
informant-reported outcome measures and will be useful to screen people with AD/ADRD for 
financial hardship if the patient cannot report for themselves. The third set of measures (set 3) will 
assess the patient’s financial health as reported by the patient for people with AD/ADRD who are 
able to report for themselves. Clinicians will be able to use the patient-reported measures to screen 
people with mild AD/ADRD who can report for themselves (set 3) and the caregiver-reported 
measures to screen people with AD/ADRD who cannot (set 2). Clinics with programs to assist 
caregivers can also use set 1 to screen caregivers. Patient and caregiver report do not always align 
with other data sources46 and patients and caregivers might be reticent to share financial struggles 
unless directly asked.47,48 For this reason, we aim to create these ten measures to directly screen 
patients and caregivers for financial hardship.
We will use an innovative psychometric method, item response theory (IRT), to develop 
measures for each of the three financial hardship domains in each set and for the financial function 
measure for a total of ten measures. These measures, often called item banks, are collections of 
survey and questionnaire items that can be used in different combinations and administration 
methods. The measure development process will include interviews with caregivers of and people 
with AD/ADRD to identify indicators of financial hardship specific to AD/ADRD and the point in 
the lifespan in which it occurs. Feedback will be solicited from AD/ADRD experts on the initially 
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developed measures. We will then survey a large sample of people with AD/ADRD and caregivers 
of people with AD/ADRD to use IRT to create the final measures. We will survey multiple 
caregivers per patient and patient-caregiver pairs when possible to assess reliability across the item 
banks. Potential bias on the financial hardship measures will be assessed for the following factors: 
race, ethnicity, patient comorbidities, stage of AD/ADRD, pre-AD/ADRD socioeconomic status, 
caregiving relationship, size of social network, number of caregivers, financial support from the 
social network, and the caregiver’s own health status. The result will be a suite of measures for 
screening for financial hardship in AD/ADRD that can be used across disease stage, caregiving 
relationships and different groups including historically marginalized populations.
Objectives 

Aim 1: Develop financial hardship screening measures for Alzheimer’s Disease and related 
dementias
o
Aim 1a: Identify indicators of financial hardship in Alzheimer’s Disease and related 
dementias. 
o
Aim 1b: Refine item banks to measure financial hardship in Alzheimer’s Disease and 
related dementias. 

Aim 2: Create item response theory-based screening measures for financial hardship in 
Alzheimer’s Disease and related dementias. 

Aim 3: Evaluate the financial hardship measures across patient and caregiver populations. 
Subject Population and Inclusion/Exclusion Criteria 
Aim 1a: Eligibility criteria will include self-reported diagnosis of Alzheimer’s disease or related 
dementia for patients OR self-reported status as a financial caregiver to a person with AD/ADRD. 
Additional eligibility criteria will be age 18 years or older; able to read and speak English or 
Spanish; able to provide informed consent; and located in the United States. We will recruit up to 60 
participants for this aim.
Aim 1b: Eligibility criteria will be 18 years of age or older; able to read and speak English; able to 
provide informed consent; located in the United States; and self-identifying clinician who primarily 
treats people with AD/ADRD OR a scientist who primarily studies AD/ADRD. We will recruit up 
to 20 participants for this aim.
Aims 2 and 3: Eligibility criteria will be age 18 years of age or older; able to read and speak English 
or Spanish; able to provide informed consent; and either a financial caregiver to someone with 
AD/ADRD or told by a doctor that they have AD/ADRD. Caregivers will also be required to 
provide some amount of financial management or support for the person with AD/ADRD. We will 
recruit up to 1000 people with Alzheimer’s Disease and up to 1400 caregivers for this aim.
Recruitment Methods 
Aim 1a: 
Participants will be recruited through advertisements on social media and news media, and 
notices in newsletters and flyers posted with organizations that work with people who have 
AD/ADRD and their families. Participants will also be recruited through ResearchMatch, which is 
an organization run by Vanderbilt University that connects researchers with potential participants. 
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Once a study is posted on ResearchMatch, potential participants receive a brief email describing the 
study and eligibility criteria and if they are interested, can release their contact information to the 
study team. Participants will also be recruited through purchased postal mail lists and will receive 
postcards and letters with information about the study. 
Interested potential participants will see the study advertisement, email, postcard or letter, 
and then contact the study team directly or complete the online screening survey. Study staff will 
conduct a brief screening to ensure eligibility for potential participants who contact the team 
directly. Study staff will call potential participants who complete the online screening survey and 
confirm eligibility. For people with Alzheimer’s disease or dementia, the eligibility screening will 
be conducted by a qualified study staff member who will use a guided cognitive assessment protocol 
(described below) to ensure the potential participant understands the questions. Dr. Jones will ensure 
that all study staff administering the cognitive assessment have completed appropriate trainings 
specific for the assessment tool and will train staff in the protocol and administration of the 
assessment.
People with AD/ADRD will be asked to complete one of the three English versions or the 
Spanish version of the Montreal Cognitive Assessment (MOCA) Blind/Telephone116 to ensure they 
will have the capacity to consent and understand the study questions. The MOCA Blind/Telephone 
version includes all the items from the standard MOCA except naming pictures and drawing tasks. 
As this study will recruit participants from all over the United States, we will not be able to 
complete the visual tasks (naming, drawing) for potential participants completing the screening by 
phone. Scores on the MOCA Blind/Telephone range from 0 to 22 with the typical cutoff (cutpoint) 
score below 19 signaling possible cognitive impairment. As we would expect people with 
AD/ADRD to score below 19, if a potential participant scores below 15 (score of 14 or lower) we 
will consider them ineligible for the study as they are unlikely to be able to provide informed 
consent and consistent information on financial hardship. This cutoff was chosen based on a 
systematic review of the sensitivity and specificity for MOCA cutoffs117 and cutoffs for mild 
impairment on the full MOCA.118 Dr. Jones is a clinical psychologist who has both training and 
experience using the MOCA and would be able to train study staff to administer the assessment with 
fidelity.
Aim 1b:
Participants for the survey of Alzheimer's disease and dementia experts will be recruited 
through the investigative team’s networks and through identifying current experts in the social and 
behavioral aspects of Alzheimer’s disease and dementia. The investigative team may also partner 
with professional organizations and place advertisements in professional publications to recruit 
experts. Potential participants will receive an email invitation from the study team to complete the 
survey. The email will contain a link to the online survey with the informed consent statement.
Aims 2 and 3:
We will initially start recruiting potential participants through address-based sampling. Using 
purchased postal mail lists, potential participants will receive a postcard in the mail with a brief 
description of the survey and a link and QR code to the eligibility screening survey. This will allow 
potential participants to access the survey when they have internet access and it is convenient for 
them (e.g., at a family member’s home or library). Caregivers who screen eligible for the survey will 
then be taken to the consent form and survey. People with AD/ADRD who screen eligible will be 
asked to provide their name and contact information (phone number, email address) so study staff 
can conduct a cognitive screening to ensure they are likely able to provide informed consent and 
provide reliable information on the survey. The person with AD/ADRD will be administered one of 
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the MOCA Blind/Telephone versions over the phone and scores at or above 15 out of 22 will be 
considered eligible. The person with AD/ADRD will then be emailed either a link to the consent 
form and survey or mailed a hard copy of the consent form and survey, depending on their 
preference. The initial postcard will also include the study phone number and instructions that the 
potential participant can request a paper survey if they are eligible and would like to participate. 
Potential participants that call to request a paper survey will be screened for eligibility, including the 
cognitive screen for people with AD/ADRD, and mailed a paper survey with a business reply 
envelope. At least one reminder mailing will also be sent with instructions on how to complete the 
survey online and how to request a paper survey. Both people with AD/ADRD and caregivers will 
be asked to nominate either a caregiver or patient, respectively, to complete the corresponding 
version of the survey. Caregivers recruited through address-based sampling will also be asked to 
nominate a second and third caregiver, if applicable, of the person with AD/ADRD to also complete 
the survey. The second and third caregivers will be approached to complete the survey through the 
same methods as the first caregiver (online, paper) but may also be approached through phone calls 
if the first caregiver reports that may be acceptable to the other caregivers. 
Participants will also be recruited through ResearchMatch and partnerships with caregiving 
organizations. Potential participants from ResearchMatch will receive a brief email explaining the 
study and the eligibility criteria for the study. If interested, potential participants can then release 
their contact information to the study team through ResearchMatch. For potential participants 
recruited through caregiving organizations, they will either receive an email or letter about the study 
or see a notice about the study in the organizations’ newsletters. Potential participants recruited 
through caregiving organizations and are interested will then contact the study team. The study team 
will then contact the potential participants and assess eligibility using the same methods as for 
address-based sampling.
Participants will also be recruited through Qualtrics survey panels. Dr. Jones has 
successfully recruited through Qualtrics panels before.114,115,176 Qualtrics is a survey and research 
company that maintains panels of over 100 million potential survey participants. The large survey 
panels will allow us to meet recruitment goals for each racial and ethnic group. Inclusion criteria 
will be: currently a caregiver to someone with Alzheimer’s disease or dementia OR told by their 
doctor that they have AD/ADRD; 18 years of age or older; living in the United States; able to read 
English or Spanish; and able to provide informed consent. Qualtrics will invite potential survey 
participants to participate through their preferred method (email, text). Potential participants will 
answer a set of screening questions on age, caregiver status/diagnosis and location to ensure 
eligibility. People who report a diagnosis of AD/ADRD will complete an online version of the 
MOCA, Xpresso MOCA, to ensure ability to provide informed consent and participate. People that 
are eligible will then be invited to complete the survey. People who participate in Qualtrics survey 
panels receive perks for completing surveys including gift cards and frequent traveler points.
The Consent Process 
Aim 1a:
Informed consent will be obtained from each interview participant. Due to the virtual nature 
of likely most of the interviews, the informed consent process will use both verbal and written 
methods. When potential participants contact the study team about participating in the interviews, 
study staff will explain the study, send the consent form by email or postal mail and review all 
relevant aspects of informed consent for those completing the study remotely (virtual, phone). Study 
staff will answer any questions about the study. If the person agrees to participate, documentation of 
informed consent will be noted in the study database. For participants coming to the Fred Hutch 
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campus and completing te interviews in-person, written informed consent will be obtained and 
documented with an ink signature. The PI (Jones) is a clinical psychologist and will train study staff 
to notice signs that participants may not be able to consent.
Aim 1b:
Informed consent will be 
obtained from each survey participant. 
Potential participants will complete the 
screening survey and then see an 
informed consent statement. They will 
be asked to read the statement and click 
a box noting that they have read and 
understood the informed consent 
statement. Participants will then be taken 
to the survey. Contact information for 
the study personnel will be provided so 
potential participants can contact the 
study team with any questions they may 
have.
Aims 2 and 3:
All elements of informed consent 
will be included with the survey and 
participants will be required to review it 
before they complete the survey. This 
will include potential risk of 
participation and actions the research 
team takes to minimize risks. Consent 
will be documented through the online 
survey and a waiver of documentation of 
informed consent will obtained from the 
institutional review board. Written, 
signed consent forms will be used for 
people completing paper surveys.
Study Procedures 
Aim 1a:
Interviews will be conducted virtually, by phone or in-person. As we anticipate most 
participants will complete the interview by phone or virtually, both verbal informed consent and 
signed paper informed consent procedures will be used. If a patient and their caregiver are both 
participating in the interviews, each will be scheduled separately for the interview and will be asked 
to use a room where they can speak privately. A semi-structured interview guide will be developed 
by the investigative team (see Table 2). Participants will first be asked about their experience of 
financial hardship generally and then about each specific topic in Table 2. Participants will also be 
offered handouts on accessing financial support and mental healthcare. At the end of the interview, 
people with AD/ADRD will be asked if their caregiver may like to participate and caregivers will be 
asked if the person with AD/ADRD may like to participate. If the participant agrees, the other 
Table 2: Interview Guide Outline 
Interview Topics
1.
Comparison of financial situation before vs. after 
AD/ADRD diagnosis for both person with AD/ADRD 
and their caregivers
2.
General financial hardship
3.
Specific financial hardship domains (financial 
stress, financial strain, asset depletion) 
a)
Unique indicators for the age at which 
AD/ADRD usually occurs
4.
Factors that contributed to financial hardship
5.
Strategies that helped alleviate or mitigate the need 
6.
How does financial hardship affect their financial 
well-being, emotional well-being and/or behaviors
7.
How has financial hardship influenced their 
decisions about care or limited options for care
8.
Financial function
a)
How are finances typically managed (who 
manages and what are the resources they use)
b)
How financial management was transferred 
from the patient to the caregiver, and any 
events or changes that triggered the transfer
a.
How the transfer process evolved over 
time 
c)
When to ask the patient versus caregivers, or 
both
9.
How to account for multiple caregivers and social 
network size
a)
Number and composition of financial 
caregiving network and social network
b)
Change in financial caregiving network over 
time and disease stages
c)
How financial management works for the 
person with AD/ADRD across the caregivers 
d)
How the caregiving and broader social 
networks have buffered against and/or 
exacerbated financial hardship including 
effects of network wealth
a)
Who is/are the best caregiver(s) to complete 
the screening measures
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member of the dyad or family (caregiver, person with AD/ADRD) will be approached by email or 
phone to see if they would like to participate. Interviews will be recorded and transcribed. Spanish 
transcripts will be translated into English. Participants will receive a small incentive for 
participation.
Aim 1b: 
Potential participants will receive an email invitation from the study team, briefly explaining 
the study and providing a link to the survey. Interested people will click the survey link, review the 
informed consent statement and complete the survey. The survey will ask participants to review a 
definition of each domain of financial hardship and then rate the relevance of each item developed in 
Aim 1a with that domain based on who would be reporting (caregiver, patient) and who’s outcome 
is measured (patient, caregiver). In the event of very long item banks being developed in Aim 1a, 
participants will only review a randomized portion of the items. Demographic and job characteristic 
information will also be collected. Participants will receive a small incentive for participation.
Aims 2 and 3:
Once participants screen as eligible, they will either be taken directly to the online survey or 
receive the survey and consent form in the mail. Participants completing the survey online will 
review the consent statement, indicate they have read it and then proceed to the online survey. 
Participants completing the survey by mail will sign the consent form, complete the survey and then 
return both in a business reply envelope. Each participant will receive a small incentive to thank 
them for completing the survey. Participants will also receive handouts on accessing financial 
support and mental healthcare.
Endpoints and Measures 
Aim 1a:
There are no formal measures for this aim as the purpose of the aim is qualitative. The 
endpoint is development of indicators of financial hardship in AD/ADRD and a better understanding 
of the patient and caregiver experience.
Aim 1b:
Participants will be asked to rate the relevance of each item from the preliminary item bank 
to the corresponding financial hardship domain using a 4-point scale (Not relevant, Somewhat 
relevant, Quite relevant, Highly relevant).161 Qualitative feedback on the survey will be solicited 
through an open text field after each domain that asks for feedback on missing items or concepts for 
that domain as well as items that are misplaced and should be moved to a different financial 
hardship domain.
Aims 2 and 3:
Measures for Aims 2 and 3 will be developed based on the results of Aim 1. The measures 
will include each dimension of financial hardship (stress- psychological; strain- difficulty meeting 
needs; asset depletion) for the patient (both reported by the patient and by the caregiver) and the 
caregiver. There will also be a measure of financial function reported by the patient. Demographic 
and disease information will also be collected. Quality of life measures from the Patient-Reported 
Outcomes Measurement Information System, the Social Network Index, the Perceived Stress Scale 
and measures of pre-AD/ADRD socioeconomic status will also be included to validate the 
measures.
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Statistics and Rationale for Number of Subjects 
Aim 1a:
For the interviews, we will use an inductive analysis process. The post-doctoral fellow, the 
study coordinator and Dr. Jones will read the transcripts and develop a preliminary codebook. The 
codebook will be reviewed by the investigative team. The post-doctoral fellow and coordinator will 
then double-code 10% of the transcripts to ensure reliability. Disagreements will be resolved 
through consensus or review by the investigative team. The two coders will then code the remaining 
interview transcripts. Dr. Jones will then analyze the coded interviews in conjunction with the 
investigative team to identify key indicators of each financial hardship domain for both caregivers 
and patients and for both patient-reported and caregiver-reported measures. Analyses will be 
stratified by social network size, number of caregivers, financial support from the network, income 
levels and race/ethnicity to identify differences in the experience of financial hardship.
Results from the interviews will inform generation of new financial hardship items and 
revision of items from previous measures. We will include items from previous measures7-16,119-157 if 
permission is given to use the items in creating these new measures and if the investigative team 
deems the content relevant to those with AD/ADRD, the part in the lifecycle in which AD/ADRD 
usually occurs and to AD/ADRD caregivers. Items from previous measures will be revised to reflect 
the stage in the lifecycle at which AD/ADRD typically occurs and the advisory board will review 
the revised items. Based on the coding and analysis of the interviews, additional items will be 
generated either by using direct quotes or by generating item text that captures the content of what 
participants reported. For example, a caregiver participant might report that their loved one’s cell 
phone was shut off because they forgot to pay the bill. An item on the caregiver 
(observer/informant) reported measure for the patient’s financial health might then be “phone 
service interrupted because they forgot to pay bill.” As another example, a patient might report 
feeling so anxious about paying for home care that they were jumping out of their seat. An item on 
the patient-reported measure for financial stress might then be “felt anxious about paying for home 
care.” Items from the interviews and previous measures will be harmonized to have a consistent 
format including response options. Items will be generated and categorized into each financial 
hardship domain by the post-doctoral fellow and Dr. Jones and then reviewed by the entire 
investigative team with the results of the qualitative interviews. The caregiver and patient advisory 
board will provide feedback and revisions on items generated through this process.
Previous studies have suggested 15 interviews may be sufficient to achieve saturation158,159 
and these sample sizes are standard for concept elicitation in measure development.160 We will 
define saturation as no new items being identified for a financial hardship domain after coding an 
interview and saturation will be verified by all coders, then reviewed with the investigative team.
Aim 1b:
The quantitative portion of the survey will use the content validity index (CVI).161,162 Items 
will be retained if 78% of participants rated the item relevance as quite or highly relevant to that 
financial hardship domain, consistent with current guidelines for interpreting the CVI.161 The 
principal investigator and post-doctoral fellow will review the comments from the open text fields 
and draft new items based on the comments. The investigative team will review the revisions and 
amend any items that need to be reworded or moved to other domains. The advisory board of people 
with AD/ADRD and caregivers will review the feedback from experts and the investigative team’s 
revisions. The advisory board will be asked to provide further feedback on the changes and any 
missing items. Based on the quantitative and qualitative data, the preliminary item banks will be 
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revised for testing in the larger survey (Aim 2). The final item bank will be translated into Spanish 
using recommended methods for measure translation.61
Aims 2 and 3:
Item response theory (IRT) is a family of statistical models for creating a quantitative score 
from self-reported and observer-reported data.179,180 IRT uses the logistic model to determine the 
severity (also called the threshold parameter) of each item from surveys and questionnaires and 
reflects content validity. IRT also accounts for the accuracy (also called the slope and reflecting 
reliability) for each item, weighting items with better accuracy higher than items with lower 
accuracy. This differs from traditional analyses that would simply weigh all items equally. IRT uses 
the construct itself, financial hardship in this case, to create the weights instead of relying on an 
outside outcome, allowing the severity and accuracy parameters to be used across settings and 
outcomes for clinical screening and research without additional validation.
IRT uses the logistic statistical model. The severity and accuracy parameters for each item 
are estimated from large (400+) survey samples of responses to the items using maximum likelihood 
or estimation-maximization (EM) procedures. For Aim 2, we will use two IRT models. The first is 
the two-parameter logistic (2PL) model that estimates a 
single severity and single accuracy parameter for each item 
and is best suited to dichotomous, yes/no items such as 
“have you taken money out of savings due to your loved 
one’s Alzheimer’s disease or dementia.” The second IRT 
model is the graded response model (GRM) that estimates a 
single accuracy parameter and a set of severity parameters 
for items with three or more response options. Each severity 
parameter in the GRM corresponds to the level of financial 
hardship needed before a person will select the next highest 
response option. The GRM is best suited for items with 
ordinal response options such as never-rarely-sometimes-
often-nearly always. For this study, we will use the Bock 
Aitkin EM method for estimating the severity and accuracy 
parameters in the 2PL and GRM models.181 We will examine the accuracy parameters for each item 
and eliminate items with low accuracy (<1).182 We will then use these parameters to create scores 
for each domain of financial hardship (Table 1) using a Bayes estimator.183 The usual scale of 
measurement for IRT measures is a mean of 0 and standard deviation of 1.
To further evaluate reliability for the financial hardship measures, we will examine the test 
(measure) error function, which is the inverse of the test information function created in IRT 
analyses.17 In IRT, reliability is not conceptualized as a single measure, but rather as varying at 
different levels of the construct. For example, a measure of financial stress may be more reliable for 
people with higher levels of financial hardship, but less reliable for people with high socioeconomic 
status and less financial hardship. For each of the financial hardship item banks, we will examine 
reliability (conversely, error) along the continuum of the construct by creating a test error curve 
(examples in Figure 1). The test error curve shows where the item banks are most accurate and 
informs use of the item banks. If the item banks have low error along a wide range of the continuum 
(two standard deviations below to two standard deviations above the mean, grey solid line, Figure 
4), this would indicate that the item banks are suitable for monitoring changes in financial hardship 
or categorizing people into low, medium and high levels of hardship. If the item banks have much 
lower error in a specific point on the continuum (blue dashed line, Figure 4), this would indicate that 
the item banks are suitable for screening people for high and low levels of financial hardship. For 
Figure 1: Example of standard error curves 
for item response theory analyses. Solid grey 
line is suitable for monitoring change over 
time and screening into multiple tiers. 
Dashed blue line is suitable for screening 
into two groups (high vs. low).
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the financial function measure, we will examine the test error curve to determine cutoffs of high, 
moderate and low involvement of the person with AD/ADRD in financial management. The high 
group would indicate the PRO financial hardship measures could be used for screening. Moderate 
involvement would suggest using both PROs and caregiver-reported ObsROs and low involvement 
would indicate use of only the caregiver-reported ObsROs for financial hardship screening. The root 
mean square error of approximation (RMSEA) will assess the overall fit of the IRT model.184 
The IRT scores will then be compared to health outcomes such as stress and quality of life to 
assess the construct validity of each financial hardship item bank. To evaluate the construct validity 
of the item banks, we will run a series of multiple linear regressions to assess the association of the 
financial hardship item bank scores with perceived stress and quality of life. We expect higher levels 
of financial hardship to be associated with higher levels of perceived stress and lower quality of life. 
Covariates will be age, gender, race/ethnicity group, and income, as these can influence level of 
financial hardship. A significant negative association between financial hardship and quality of life 
and a positive association between financial hardship and perceived stress will support the construct 
validity of the item banks.
An additional benefit of IRT analyses is the creation of short, pragmatic, standardized 
measures that can be used to screen patients. Measures for this purpose must be short (4 items or 
less) to reduce respondent burden. With IRT, severity and accuracy parameters can be compared and 
if two items have nearly identical parameters, this suggests the items are redundant and one could be 
eliminated while still covering the full breadth of the construct. This approach also means that users 
of the measure can choose different sets of items to use if their patient population has unique needs. 
We will examine the severity parameters and select two to three items from each item bank that help 
distinguish financial hardship at approximately 1.5 standard deviations above the mean and select 
these for initial short forms. Based on IRT analyses of previous social risk and financial hardship 
measures,185 we hypothesize that error will be lowest between 1 and 2 standard deviations above the 
mean. Using 1.5 standard deviations would capture both people with very high levels of financial 
hardship that need immediate help but also people with moderate levels of financial hardship that 
could benefit from less intense intervention to prevent worse financial hardship. If the standard error 
curve suggests error is lowest at another point besides 1.5 standard deviations above the mean, the 
investigative team will then discuss using a different cutoff for positive versus negative screens and 
creating clinical interpretation guidelines. The advisory board of caregivers and people with 
AD/ADRD will provide feedback on the selection of the items for the standardized screening short 
forms to ensure the selected items reflect what is important to caregivers and people with 
AD/ADRD.
Once IRT-based item banks and short screening forms are developed as described above, 
screening can be conducted in a variety of ways. The first is using computerized adaptive testing 
(CAT). In CAT, patients or caregivers answer an initial question and receive different questions 
based on the level of financial hardship indicated by their answer to an initial question. Subsequent 
items are tailored to the estimated level of financial hardship from items already answered so people 
only answer questions relevant to their level of financial hardship. CAT is often more efficient than 
traditional statis measures.50 A second method is to use the short forms created as part of Aim 2 or 
create a clinic-specific short form from the item banks and use the electronic health record or other 
computer program to use the severity and accuracy parameters to create IRT-based scores, similar to 
how PROMIS measures can be integrated into clinical practice and to how scores will be created for 
construct validity analyses in Aim 2. A third method is called sum score conversions.186 With sum 
score conversions, answers to items on the short forms are summed similar to classical test theory 
measures and then the summed scores are transformed into IRT-based scores using a conversion 
table. Sum score conversion is not as precise as the other two methods but is an important option for 
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clinical practices that do not have information technology support and other computer resources to 
use CAT or scoring using accuracy and severity parameters. PROMIS has created sum score 
conversion tables57,187 and this has made the measures more accessible. As part of the Aim 2 
analyses, we will create sum score conversion tables for each of the ten item banks and each 
standardized screening short form. Using IRT to create all three scoring methods for screening puts 
scores on a standardized, comparable metric. After successful completion of Aim 2, all three 
methods of scoring and using the financial hardship screening measures will be available for use.
To examine how assessing both caregivers and patients and number of caregivers may affect 
observer/informant report of patient financial hardship, we will examine interrater reliability of the 
three ObsRO item banks (caregiver-report of patient financial stress, financial strain, asset depletion, 
set 2) across caregivers and interrater reliability of the three ObsRO item banks (set 2) with the PRO 
item banks (set 3). The interrater analyses will be limited to the caregiver sample where multiple 
caregivers participated and to the subsample where both the patient and caregiver participated, 
respectively. The caregiver who is most involved in financial management for the patient will be 
defined as the index caregiver for these analyses. Agreement between the two or three caregivers on 
each item will be assessed using the prevalence and bias adjusted kappa.188,189 Kappas above 0.60 
will indicate good agreement or interrater reliability. The overall scores on each financial hardship 
dimension will be compared between caregivers and between the caregiver and patient using the 
intraclass correlation with values above 0.70 indicating good interrater reliability. If interrater 
reliability is good, this would mean any caregiver managing the patient’s finances could complete 
the ObsRO for the patient or that either the patient or caregiver could complete the screening. If 
interrater reliability is below the cutoffs, this would suggest that clinics should ask only the 
caregiver who is most involved in financial management to complete the screening of the patient’s 
financial hardship. 
We will use differential item functioning (DIF) 
analysis to ensure that the financial hardship item banks 
are not biased between racial and ethnic groups; by pre-
AD/ADRD socioeconomic status; income; stage of 
AD/ADRD; comorbidities and disabilities for the patient 
and caregiver; social network size; caregiving relationship; 
and number of caregivers providing financial help and 
amount and type of financial help. Bias can sometimes 
hide true differences that are disparities and/or inequities. 
Differential item functioning analyses use the IRT models 
described above, but models and tests for statistically 
significant differences in the severity and accuracy 
parameters between groups.192 For example, DIF would 
model separate severity and accuracy parameters for those 
who are a spousal caregiver and those who are an adult 
child caregiver and then compare the parameters for 
statistically significant differences using the chi-square 
test. The top panel in Figure 2 shows what is called 
standardized DIF,17 where only the severity parameter 
differs. This means Group 1 needs more financial hardship 
before they will endorse the item and can give the illusion 
that there is no difference between groups when there 
actually is a disparity. The second panel of Figure 2 shows non-standardized DIF,17 where the 
accuracy (slope) parameter differs between groups. In the example, the item is more accurate and 
Figure 2: Item characteristic curves for 
dichotomous items testing for differential item 
functioning (bias).
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reliable for Group 1 than for Group 2. DIF analyses compare multiple parameters across multiple 
items increasing the chance of a false positive for finding bias so a Type I (one) error correction will 
be used.193-195 If significant bias is found, we will calculate scores with and without adjustment for 
bias and then compare the scores using an intraclass correlation to quantify the effect size of the bias 
and determine whether bias is larger enough to be meaningful (i.e. intraclass correlations of <0.95). 
In Aim 3 we will use DIF to test for bias on each of the three financial hardship dimensions 
and the financial function item bank. When there are three or more groups in a DIF analysis, 
comparisons can be made one of two ways. The first approach compares each group to a reference 
group similar to logistic regressions. The second approach compares all groups to each other. We 
plan to use the second approach for DIF analyses of bias by racial group and caregiver relationship 
as choosing a clear reference group would exclude other comparisons such as when the white group 
is chosen as a reference group and this excludes comparisons between racial minority groups. For 
both people with AD/ADRD and caregivers we will compare the following groups for DIF: each 
racial group (white, Black/African-American, Asian American, Native American, Pacific Islander) 
to every other racial group; people who are Hispanic or Latino/a to people who are not; gender 
identity; sex; 0-1 comorbidities versus 2 or more comorbidities; number of caregivers; financial help 
provided from social network; above versus below the median for Social Network Index score; 
above versus below median for income; and above versus below the median for pre-AD/ADRD 
social status.6 For caregivers, we will make additional comparisons between the following groups 
for DIF: 0-1 caregiver comorbidities versus 2 or more caregiver comorbidities; caregiver disability 
versus no reported caregiver disability; relationship to the patient (spouse, unmarried partner, adult 
child, other); and above versus below the median for pre-AD/ADRD social status. If specific items 
are significantly and meaningfully biased, those items will be eliminated or separate scoring 
algorithms will be created that corrects for the bias. We will bring results to our advisory board of 
people with AD/ADRD and caregivers for feedback on the most appropriate approaches to 
correcting for this bias and integrate their suggestions into the final item banks.
Although IRT models typically require a minimum of 400 to 500 responses to create item 
parameters based on simulation studies and general practice, we will recruit a larger sample of 1000 
people with AD/ADRD and 1000 caregivers to ensure sufficient representation of people from racial 
and ethnic minority populations.57,190,191 Having enough participants from different subgroups is 
needed for differential item functioning analyses that will be conducted in Aim 3. Simulation studies 
have also suggested that measures with more items (30 to 240) can require sample sizes up to 1000. 
A sample size of 1000 will ensure accurate parameters if our item banks have more than 30 items. 
Risks and Benefits 
We anticipate this study will present minimal risk to participants. The most relevant risk for 
this study is breach of confidentiality. As outlined in Data Management and Confidentiality, we will 
take several precautions to ensure participant information remains private. 
There are also potential risks for people with AD/ADRD participating due to the symptoms 
of the disease. While people with AD/ADRD will participate in this study, the study team will 
conduct an assessment to ensure they are able to understand study procedures and the risks of 
participation in this minimal risk study. The purpose of this study is also specifically to benefit 
people with AD/ADRD and their families/caregivers.
No direct benefits for participants are anticipated although they may find it beneficial to 
share their views on financial hardship of people with AD/ADRD and their caregivers. Results will 
be beneficial to scientists studying these diseases and their associated financial hardship, as the 
resulting item bank will allow harmonization between studies while still allowing customization for 
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specific study purposes. The resulting item banks will also create AD/ADRD financial hardship 
outcome measures that are more sensitive to change, improving power for future studies. The item 
banks will also be useful for tailoring clinical screening to each clinic and their patient population 
while providing a rigorously developed method of scoring AD/ADRD financial hardship. 
Qualitative results will also provide important context and understanding of the role of financial 
hardship in caring for people with AD/ADRD and supporting their caregivers.
Data Management and Confidentiality 
We will use secure, HIPAA compliant virtual platforms for the interviews and keep all data 
and information in secure servers (firewalls, password protection). Survey data will be kept on 
secure online platforms and data will be downloaded only onto secure servers. Access to 
information will be limited to study staff and will be reviewed regularly. Transcripts will be 
deidentified and recordings will be deleted once the study is complete. Survey data will be de-
identified when creating an analytic dataset and will be kept separately from information used to 
send incentives. We will also use unique identifiers for each participant and delete identifiable 
information once the study is complete. 
Use of Data 
Data will be used primarily to complete the three aims outline in Objectives. However, 
secondary data analyses may be conducted to further identify the causes and effects of financial 
hardship for people with AD/ADRD and their caregivers.
Provisions to Monitor Data and Protect Privacy
Only study with a reason to access the data or participant information will have access to 
study files. As outlined under Data Management and Confidentiality, we will only use secure virtual 
conference platforms and online data collection platforms to protect privacy. Any phone calls with 
participants will be conducted in a private office with the door closed. The PI will meet with study 
staff at least monthly to discuss any problems or concerns with the study procedures and participant 
experience.
Data for Aims 2 and 3 will be checked to ensure response quality. This includes checking for 
duplicate answers (participant completed survey twice), likely inattention (answering the most 
extreme option for each question, answering attention check questions incorrectly)177,178 and 
skipping most of the questions. Measures to assess for fraud will be used such as extremely fast 
completion times for online surveys or unlikely response patterns.
Qualifications to Conduct Research and Resources Available
The principal investigator is a clinical psychologist, behavioral and social scientist and 
psychometrician with over 15 years of experience in scientific research and over 80 peer-reviewed 
publications. She has previous experience with developing patient-reported outcome measures 
including a current project developing measures of financial hardship for people with cancer. Dr. 
Kent is a health services researcher and expert applying mixed methods (qualitative-quantitative) to 
studying caregiver lived experiences,84-87 including recent work redefining caregiving based on 
profiles of experience rather than care recipient health condition. Dr. Ornstein is an epidemiologist 
who studies dementia caregiving and the burden and cost of dementia. Dr. Samuel is a nurse 
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practitioner and expert in the experience of financial hardship and its effects on health among older 
adults. She has extensively studied the unique markers of health-related financial hardship among 
older adults and their families and the role of financial hardship in shaping disparities related to race, 
ethnicity and disability status using both qualitative and quantitative methods.24,25,36,44,45,94-102
Study Timeline 
Appendix 1: Consent Forms
Appendix 2: Interview Guide
Appendix 3: Measures (Survey)
Appendix 4: Recruitment Materials and Screening Scripts
Activity
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Recruit advisory board and  interview participants
Conduct interviews
Qualitative analysis and develop preliminary item banks
Survey experts
Finalize item banks
Publication and dissemination
Survey caregivers and people with AD/ADRD, address-based 
Evaluate current samples
Survey caregivers and people with AD/ADRD, survey panels
IRT analyses, construct validity analyses, create short forms
Publication and dissemination
DIF analyses
Revision of the item banks if needed
Publication and dissemination
Aim 2
Aim 3
Year 1
Year 2
Year 3
Year 4
Year 5
Aim 1
Figure 6: Study Timeline
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