Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05382949 |
| Other study ID # |
074126 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Silverbills, Inc. |
| Contact |
Lisa Rosenblum |
| Phone |
855-553-7330 |
| Email |
NIHStudy[@]SilverBills.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Financial and legal management for persons with dementia (PwD) is a crucial responsibility of
caregivers. This responsibility adds to the stress and strain of caregiving. Current
technology tools that help with bill management and budgeting often require a high degree of
technical expertise and provide an insufficient degree of personal support to address the
caregivers' needs. Current approaches to financial management are typically aimed at
technologically savvy millennials rather than caregivers. Additionally, these approaches do
not address the need for safe and accessible storage of legal documents. Thus, the current
solutions available for these tasks are a mismatch for caregivers. The investigators will
address the lack of effective financial management and legal support for caregivers of PwD.
Using proprietary technology, SilverBills receives, scrutinizes, stores, and pays bills on
behalf of clients. The goal of this project is to decrease the stress and strain on
caregivers of PwD, by providing a simple, safe, and effective financial and legal management
tool. The investigators aim to build an easy to use, customizable, client facing application
for caregivers to direct the financial activities of PwD. In addition, The investigators will
enhance the capabilities of the application to reconcile banking information, detect fraud,
secure data, provide enhanced reporting capabilities and provide further budgeting and
planning functionality. Finally, in collaboration with researchers from the University of
Denver, The investigators will assess caregiver burden and physical, financial, and emotional
distress. The team supporting Silverbills V2 includes expertise in elder law, business
development, Ruby on Rails software engineering, financial security and cognitive health,
caregiving, research design and statistics. The work proposed should demonstrate that the
SilverBills V2 product will: 1) Provide a financial management tool which includes a
messaging system and vault of critical documents for caregivers of PwD and/or older adults,
and 2) Evaluate the effectiveness of our product to decrease caregiver stress and increase
caregiver quality of life. This team will support the rigorous scientific validation which
will potentially provide evidence of our innovation and support this critical work to provide
technological tools for financial and legal management to caregivers of PwD.
Description:
Research has demonstrated that education, information and support improve caregiver
wellbeing, improve their mental health, and delay the need to move the persons with dementia
(PwD) to along-term care setting. Caregivers are often responsible for managing the legal and
financial affairs for PwD. This responsibility adds to the stress and strain of caregiving.
The SilverBills client-facing application provides an easy to use, efficient financial and
legal management tool to caregivers, decreasing caregiver burden. In order to assess the
effectiveness of the SilverBills tool, the investigators will measure caregiver burden as
well as mental, physical and financial health (baseline and post-intervention).
Research Questions:
1. What are the effects of a client-facing application on the primary outcome (caregiver
burden) between baseline (T1) and end (T2) of the study?
2. What are the effects of a client-facing application on the secondary outcomes (mental,
physical, and financial health) between T1 and T2?
3. What are the moderators of the effects of client-facing application on the primary
outcome and secondary outcomes between T1 and T2?
To achieve the aims of this proposal, recruited participants will remotely and electronically
(via Qualtrics data collection software) provide informed consent for research. Participants
will be recruited as detailed in the recruitment and retention plan. Participants will meet
the following screening criteria: a) Participants must be caregivers aged 18 or above; b)
participants must be caregivers of people with dementia; and c) participants are able to
provide consent without the aid of another individual.
Participants will complete two surveys at two different time intervals. The first survey will
take place at the outset of the research study when the participants are enrolled (T1). The
second and final survey will be administered 6 months after the start of the study (T2). The
entirety of the data collected throughout this project will be converted into
password-protected files (e.g. xlsx), which will be stored in secured electronic platforms
(i.e. password-protected OneDrive) that only select team members will have access to. Survey
items will be multiple choice and should take respondents no more than 15-20 minutes to
complete.
