Treatment Trials

15 Clinical Trials for Various Conditions

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RECRUITING
DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
Description

The DISCO App is designed to improve, during the interaction, patient active participation and patient-initiated oncologist treatment cost discussions, and, in the short term, patient's treatment cost knowledge, self-efficacy for managing both cost and physician interactions, referrals, perceived financial toxicity (i.e., distress and material hardship); in turn, these will affect longer-term outcomes of financial toxicity and adherence.

ACTIVE_NOT_RECRUITING
Financial Burden Assessment in Patients With Stage I-III Colon or Rectal Cancer Undergoing Treatment
Description

This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances.

NOT_YET_RECRUITING
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Description

Background: There are an estimated 163 million children worldwide who are under the care of their grandparents or other relatives. In Uganda, social determinants of health (i.e., poverty, wars, and maternal and perinatal conditions) threaten the middle generation (age 15-49) and leave older adults, especially grandmothers (Bajjajja), to become the safety net. Yet, in this region, knowledge about effective interventions that support the health and wellbeing of these GMCs is limited to nonexistent. As such, Dr. Matovu proposes to refine, adapt, and test her BAJJAJJA intervention that she developed. Specific Aims: Dr. Matovu will achieve this goal through three Specific Aims: 1. Refine and adapt the BAJJAJJA intervention components through a collaborative and iterative feedback process with a diverse community group of 18 members; 2. Test the feasibility, acceptability and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs; and 3. Explore the barriers and facilitators to (3a) maintenance of the BAJJAJJA individual intervention benefits and (3b) sustainability of the income generating activity at 6 months post-intervention. This innovative study will utilize a community-engaged approach that emphasizes the meaningful involvement of community partners to develop an intervention that targets GMCs. Her outcomes will support her future efficacy clinical trial to test a novel multi-component and community-engaged BAJJAJJA intervention to promote the mental, physical, and economic wellbeing of GMCs.

COMPLETED
Discussing Costs in the Doctor-Patient Encounter
Description

Background: - The costs of medical care have a major effect on patients during illness and treatment. Surveys with patients and doctors show that both are interested in discussing the costs of treatment. But they rarely talk about these issues. Both worry about whether it is appropriate to discuss financial matters in the clinical setting. They are also concerned about whether this topic will be an awkward one. Researchers are interested in studying how people want their doctors to talk to them about the costs of illness and medical care. Objectives: - To explore and better understand patients views on whether and how doctors should talk about the costs of illness and medical care. Eligibility: - English- or Spanish-speaking adults (at least 18 years of age) who are covered by health insurance. Design: * Participants will be asked to take part in a 2 1/2-hour focus group. Ten to 12 people will come together to discuss their thoughts and opinions. * A member of the research team will lead the group discussion. The leader will ask a list of questions about health care payment issues. Those in the focus group will discuss these issues. * Participants will receive a small cash payment and a light snack.

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

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.

COMPLETED
Asthma Clinics Helping Expand Cost Conversations
Description

Healthcare costs are a critical barrier to U.S. families' ability to access the preventive care needed to manage their children's asthma. Asthma specialty care teams are uniquely positioned to help families navigate these cost barriers, but lack structured approaches to discussing this sensitive and complex topic. This study will train asthma specialty care teams to identify families at risk for financial burden and engage in conversations about strategies to manage asthma care costs. The study team will evaluate the impact of a health care provider training on the frequency of cost navigation conversations. The investigators hypothesize that the health care provider training will increase the frequency of parent-reported cost conversations in the clinic.

COMPLETED
Asthma in Families Facing Out-of-pocket Requirements Due to COVID-19
Description

In addition to its impact on health, the COVID-19 pandemic led to increased unemployment and loss of employer-sponsored insurance coverage. Obtaining coverage can be challenging and eligibility for public programs and subsidies can be limited, and those who do not qualify can face steep premiums, high-deductibles, and high out-of-pocket costs. Disruptions to employment and insurance coverage during the pandemic threaten to negatively affect asthma care and outcomes. Our parent project, Asthma in Families Facing Out-of-pocket Requirements with Deductibles (AFFORD), found that patients with asthma may be particularly vulnerable to insurance-related cost barriers and challenges navigating health insurance. Together with the Asthma and Allergy Foundation of America (AAFA), the investigators developed an asthma chat bot to help patients with asthma navigate insurance benefits and optimize health care decisions. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage and how to find lower-cost alternatives for asthma care. In this supplement to the AFFORD project, the investigators propose a new study to understand and address the insurance and health care cost challenges faced by patients with asthma who lose employer-sponsored coverage due to COVID-19. Our Aims are: 1) to conduct a pilot randomized controlled trial to evaluate the effectiveness and feasibility and acceptability of an insurance navigation intervention, including the chat bot, to help patients with asthma regain coverage after the loss of job-related insurance during the COVID-19 pandemic; and 2) to qualitatively explore the experiences of Aim 1 participants to understand barriers and facilitators to accessing coverage and asthma care more broadly during the COVID-19 pandemic The study hypothesis is that participants receiving the intervention will be more likely to have coverage after four months and less likely to report non-adherence to asthma medications, delayed/forgone asthma care, and financial burden than those receiving usual care. Findings will provide evidence about the effectiveness of strategies to obtain coverage and maintain access to affordable asthma care and can inform ongoing and future decision making in response to the COVID-19 pandemic and other public health and economic threats.

Conditions
COMPLETED
Out of Pocket Cost Communication in Multiple Sclerosis Patients
Description

This is a prospective randomized controlled trial of a cohort of adult multiple sclerosis (MS) patients visiting an outpatient neurology clinic. Sixty participants will be randomly assigned to the intervention arm or a control arm and will be followed for three months.

COMPLETED
Understanding Value in Metastatic Breast Cancer
Description

The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care

COMPLETED
Financial and Clinical Impact of Repeal of the Pennsylvania Motorcycle Helmet Law
Description

The purpose of this study is to find out how many helmeted versus non-helmeted motorcycle accident victims (MCA) sustain head and/or face injuries. Also, we will find out how much it costs to get medical care for head and face injuries in helmeted versus non-helmeted motorcycle victims. Finally, we will compare how long it takes helmeted versus non-helmeted motorcycle victims with face and head injuries to return to work.

RECRUITING
CONFIDENCE-AI Financial Education for Caregivers (CONFIDENCE-AI)
Description

The intervention being tested, CONFIDENCE-AI is a refined version of the original CONFIDENCE intervention made to reduce psychological financial strain and improve management of out-of-pocket care costs while increasing caregiver resourcefulness skills. Participants will be asked to participate in a 4-week intervention that includes participation in four, synchronous group-based Zoom sessions as well as between-session activities to apply learning. Participants will also receive tailored text message notifications from the NeuViCare AI-powered app via text and will be able to submit questions to the app to receive financial well-being information related to caregiving.

RECRUITING
SilverBills: A Financial and Legal Tech Tool for Caregivers
Description

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.

COMPLETED
CONFIDENCE Financial Education for Caregivers
Description

The purpose of this study is to determine how feasible it is to deliver an online course to reduce out-of-pocket costs of caregiving and reduce financial stress among Latino family caregivers to a family member living with dementia. The investigators hope that that the results of this study will help to reduce high these out-of-pocket costs and improve financial wellbeing for Latino family caregivers. Caregivers will be asked to to participate in 3 online surveys, in addition to participating in 5, 1.5 hour group-based Zoom learning sessions.

TERMINATED
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
Description

There is very limited data on the utilization of National Cancer Institute Comprehensive Cancer Center (NCI-CCC) satellite sites in general. Of what is available, most is in regards to providing chemotherapy at facilities closer to patients' home. These "satellite chemotherapy infusion centers", typically community-based treatment locations at community hospitals/facilities, freestanding clinics, or mobile units, are reported to be well liked by patients who utilize their services and reduce their travel times and expenses. In these studies patients still remained in the care of their current provider and site and are required to travel to the site for clinical visits and other appointments. It is currently unknown if patients are willing to transfer their care to a different provider to alleviate travel burden. In addition, although increased travel burden has been lower quality of life in cross-sectional studies, no data exists suggesting that these reducing travel burden can improve these outcomes intra-patient, to the knowledge of the investigators. The patient roles of the multiple myeloma clinical providers at the Siteman primary location have grown in recent years. The providers have determined a need to refer some patients to the satellite sites to relieve congestion at the site while also hopefully improving the clinical experience for those patients. This study is a natural experiment of this process.

COMPLETED
Efficacy Study of Kinto Care Coaching for Dementia Family Caregivers
Description

The goal of this clinical trial is to evaluate Kinto's Care Coaching intervention for dementia caregivers. The main questions it aims to answer are: Does the intervention help caregivers to address their general caregiving goals Does the intervention help caregivers to address their financial caregiving goals Participants will have access to: One-on-one care coaching sessions (via zoom) Up to 6 weekly support groups with other caregivers A variety of digital resources through Kinto's mobile app Researchers will compare intervention and control groups to see if the program supports caregivers' general and financial caregiving needs. The efficacy of the intervention also will be examined on key outcomes.