Caregiver BurdenNCT05382949
SilverBills: A Financial and Legal Tech Tool for Caregivers
An observational study of Caregiver Burden, run by Marci Lobel-Esrig at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- SilverBills Financial and Legal Tech Tool for Caregivers
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 investigators will recruit approximately 150 caregivers who provide care for an individual with dementia that meet inclusion/exclusion criteria.
Who may be able to join
- 18 years or older
- Provide care for an individual with Dementia
Who cannot join
- Age <18
- Lack of cognitive capacity to independently consent and complete participation (i.e., one who would require an informant)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Silverbills, Inc.
New Rochelle, New York, 10804
Lisa Rosenblum, 855-553-7330, NIHStudy@Silverbills.com
Jodi Catlow, 303-871-6203, Jodi.Catlow@du.edu
About this study
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.
Read the detailed 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:
- What are the effects of a client-facing application on the primary outcome (caregiver burden) between baseline (T1) and end (T2) of the study?
- What are the effects of a client-facing application on the secondary outcomes (mental, physical, and financial health) between T1 and T2?
- 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.
- Conditions
- Caregiver Burden
- Being tested
- SilverBills Financial and Legal Tech Tool for Caregivers
- Keywords
- Financial Management, Well-being, Dementia, Legal Management, Caregiver, Stress
- Medical subject headings
- Caregiver Burden, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverBills Financial and Legal Tech Tool for CaregiversOther
All subjects will be receiving the Silverbills financial and legal tech tool and a pre-post analysis will be conducted.
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
Zarit Burden Interview
Measured: 1 year
Secondary outcomes (3)
Mental Health
Anxiety and Depression using PHQ-9 and GAD-7
Measured: 1 year
Physical Health
Physical health component of SF-12
Measured: 1 year
Financial Distress
InCharge Financial Distress/Financial Well-Being Scale. Items are measured on a scale of 1 to 10, wherein 1 signifies significant financial concern and 10 signifies little or no financial concern.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jul 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marci Lobel-Esrig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marci Lobel-Esrig, Silverbills, Inc.
- Investigators
- Eric Chess, MD/JD, Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382949
- Sponsor's protocol ID
- 074126
- Status last verified
- Nov 2023
- First submitted
- 6 May 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SilverBills: A Financial and Legal Tech Tool for Caregivers
- ClinicalTrials.gov ID
- NCT05382949
- Acronym / sponsor ID
- 074126
- Conditions
- Caregiver Burden
- Keywords
- Financial Management, Well-being, Dementia, Legal Management, Caregiver, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Marci Lobel-EsrigUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- What are the effects of a client-facing application on the primary outcome (caregiver burden) between baseline (T1) and end (T2) of the study?
- What are the effects of a client-facing application on the secondary outcomes (mental, physical, and financial health) between T1 and T2?
- 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit approximately 150 caregivers who provide care for an individual with dementia that meet inclusion/exclusion criteria.
Key inclusion criteria (2 listed)
- 18 years or older
- Provide care for an individual with Dementia
Key exclusion criteria (2 listed)
- Age <18
- Lack of cognitive capacity to independently consent and complete participation (i.e., one who would require an informant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilverBills Financial and Legal Tech Tool for CaregiversAll subjects will be receiving the Silverbills financial and legal tech tool and a pre-post analysis will be conducted. | Other | – |
Primary outcome
Caregiver Burden
Time frame: 1 year
Zarit Burden Interview
3 secondary outcomes
Mental Health
Time frame: 1 year
Physical Health
Time frame: 1 year
Financial Distress
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Knoebel Institute for Healthy Aging - University of DenverLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Chess, MD/JD principal investigator
University of Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver Burden, run by Marci Lobel-Esrig at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Rosenblum (855-553-7330, NIHStudy@SilverBills.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.