Feasibility and Validity of Asking Patients to Define Individual Levels of Meaningful Change on Patient-Reported Outcomes.
Salene M W Jones, Yuxian Du, Ari Bell-Brown...
https://pubmed.ncbi.nlm.nih.gov/32760755/Actively Recruiting
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-19
2460
Participants Needed
1
Research Sites
13 weeks
Total Duration
This research aims to develop financial hardship screening measures specifically for individuals with Alzheimers Disease and related dementias ADADRD and their caregivers. These conditions often cause significant financial strain due to high out-of-pocket costs, reduced income, and difficult care decisions. The study addresses the lack of suitable screening tools by creating measures tailored to the unique challenges faced by these patients and their families. The study involves multiple phases. Initially, interviews with patients and caregivers will explore key financial hardship indicators and caregiving roles. These interviews will inform the creation of preliminary screening measures, reviewed by experts and advisory boards. Subsequently, large surveys will be conducted with people with ADADRD and their caregivers to refine and validate these measures using advanced statistical methods. The study also examines how factors like race, disease stage, and social networks influence financial hardship. Participants will take part in interviews and surveys, either remotely or by mail, with consent obtained appropriately. Data collected includes financial stressors, caregiving costs, and coping strategies. Researchers will analyze qualitative and quantitative data to ensure the measures accurately reflect financial hardship in diverse groups. Participants will receive compensation and informational resources. The studys results aim to improve identification of financial difficulties, guiding better support for affected individuals and caregivers.
CONDITIONS
Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia
D
Diana K Lowry, MPH
S
Salene Jones, PhD, MA
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Fred Hutchinson Cancer Center
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person)
Duration - Approximately Month 6 to Month 18 of the study
Participants complete semi-structured interviews exploring financial hardship, caregiving costs, and coping mechanisms. Interviews are conducted virtually, by phone, or in person, with privacy ensured for patients and caregivers.
1 to 2 interviews (remote or in-person)
Duration - Approximately Month 19 to Month 42 of the study
Participants complete structured surveys validating financial hardship indicators and providing demographic and caregiving information. Surveys are completed online or via mail with consent obtained electronically or by signed form.
1 survey completion (remote)
Duration - Ongoing through study completion up to Month 42
Participants’ survey data and interview transcripts undergo quality control and analysis to study financial hardship and caregiving networks. Participants receive informational handouts and compensation for their contributions.
No additional visits; data collected remotely
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor