Treatment Trials

22 Clinical Trials for Various Conditions

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COMPLETED
Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program
Description

The overall objective of this study was to develop and evaluate FINassist (Financial and Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology financial and legal navigation program. The program leverages Medical Legal Partnerships to enhance cost of care conversations with pediatric oncology patients and caregivers. FINassist optimizes the team-based care model by integrating clinicians, social workers, financial navigators, and legal advocates who work in tandem to enhance cost of care conversations with patients and caregivers, identify and intervene on patient socio-legal needs, and advocate for system-level changes.

ACTIVE_NOT_RECRUITING
The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being
Description

Black children and adults in the United States fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities result in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place- based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood micro-clusters, with a total of 480 children. The investigators hypothesize that this "big push" intervention will have significant impact on children's health and wellbeing.

ACTIVE_NOT_RECRUITING
The IGNITE Study on Concentrated Investment in Black Neighborhoods
Description

Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place-based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood microclusters, with a total of 720 adults. The investigators hypothesize that this "big push" intervention will have significant impact on overall health and wellbeing.

COMPLETED
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program
Description

This trial is a mixed-methods, non-randomized design guided by the Consolidated Framework for Implementation Research (CFIR) to develop, implement, and evaluate Coverage and Cost-of-Care Links (CC Links) -a novel financial navigation intervention for hematologic cancer survivors and their caregivers.

COMPLETED
Counterfactual Strategies, Physical Activity, and Wearable Trackers
Description

Physical activity (PA) has been suggested to lower one's risk of developing cancer, type 2 diabetes, and cardiovascular disease. While there are benefits from engaging in PA, many people do not engage in enough daily PA, thus increasing the chance of developing non-communicable diseases (NCD). Some NCDs, such as type 2 diabetes, have been shown to occur at higher rates within under-resourced populations, such as low socioeconomic status (SES) communities. Among low-SES communities, external barriers, such as cost and the surrounding physical environment, have been shown to impact engagement in PA. A multi-level PA intervention could be beneficial to help lower NCD health outcomes within at-risk groups, as well as serve as a means to further understand the barriers impeding a healthy lifestyle. At the individual level, past behavior is suggested to be a significant predictor of future behavior. When faced with a NCD diagnosis, one might think about the past and how things could have turned out differently (i.e., counterfactual thinking). For instance, what if a different action had been taken (e.g., "If only I had taken the stairs more at work")? Counterfactuals can also serve as a way of identifying causal links (e.g., "If only there were more green spaces in my area..."). Counterfactuals (CF) on behaviors that can be acted on can facilitate future behavior change by increasing intentions, motivation, and self-efficacy. In this way, CFs might help with 1) breaking a habitual sedentary cycle and 2) identify causal pathways of barriers impacting PA engagement. While preliminary data in the investigators lab suggests that CF strategies are relevant for heightening contemplation to change behaviors and intentions to change behaviors its impact on motivation and self-efficacy remains unknown. Additionally, these preliminary studies were conducted using small, undergraduate student sample, thus generalizability to low-SES individuals living in the surrounding community is unknown. For the proposed study, participants will use CFs to target barriers in different domains and levels of influence impeding PA. This identification effort will be used to work towards increasing PA behavior (collected by wearable fitness trackers). CFs will also be used to work towards increasing psychological domains relevant to behavior change over the span of 14 weeks.

COMPLETED
Tax Preparation Pilot
Description

The goal of this study to understand what percentage of families in the pediatric clinic at Boston Medical Center (BMC) currently file taxes and use free tax preparation and would accept and use referral to a free tax preparation service. The investigators specifically want to understand which of two methods of connecting to free tax preparation (referral versus navigated connection) is more effective. Also studied will be the feasibility of using surveys on financial wellness and other health indicators to track participants' health. These pilot findings will be used to design a larger study that aims to assess whether integrating free tax preparation services into a pediatric clinic can increase tax filing rates and, as a result, the amount of money families receive in tax refunds. Additionally, the investigators hope to understand whether receiving this service impacts parental stress as well as how parents and babies are using the healthcare system.

COMPLETED
Finances First: A Health Intervention in Low Income Single Mother Households
Description

The purpose of this prospective, randomized, controlled three-year study is to compare the effect of a year-long financial education program versus usual care on health outcomes in single mother low income households.

RECRUITING
PediRISE Feasibility
Description

The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program. The names of the study groups in this research study are: * PediRISE Program Group * Usual Care Group

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
Financial Support in an Underserved and Low-Income Population With Heart Failure
Description

The goal of this clinical trial is to test whether financial support in the form of a one-time $500 stipend would improve medication adherence and quality of life in low-income, socially-needy patients with heart failure with reduced ejection fraction in the post-discharge setting. The main questions it aims to answer are: * Will financial support improve heart failure quality of life? * Will financial support improve medication adherence? Participants will complete surveys on quality of life, social stress, and spending habits at their baseline visit. Participants will be randomly assigned to receive $500 at their baseline visit or $0 at their baseline visit. At their one month visit, quality of life and medication adherence will be assessed. These results will be compared between groups. The group that received $0 at their baseline visit will be provided $500 at their one-month visit and return for a two-month visit. At that visit, quality of life and medication adherence will be assessed. These results will be compared to their one-month results. Researchers will compare the 1-month quality of life scores and medication adherence scores between the immediate financial support vs delayed financial support. Researchers will also compare 1-month vs 2-month quality of life and adherence data for participants who were randomized to the delayed financial support group.

COMPLETED
Financial Navigation Study Among Young Adult Blood Cancer Survivors
Description

Young adult cancer survivors (18-39y) are at increased risk of financial distress. This study seeks to better understand the financial challenges experienced by these individuals via quantitative serial assessments, study-based financial navigator encounters and an end of study qualitative interview.

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.

SUSPENDED
From Hardship to Hope: a Peer-led Intervention to Reduce Financial Hardship and Suicide Risk
Description

Financial hardship is an important risk factor for suicide. However, to date there are no evidence-based interventions to help individuals improve their financial situation and thus reduce suicide risk. The aim of our study is to develop a 24-week, peer-led intervention to reduce financial hardship for individuals experiencing financial difficulties and suicide risk, and to test whether it is feasible, acceptable to clients and achieves its desired effect. The intervention will support participants to address their financial difficulties (e.g., debt, inability to meet basic needs) by coaching them on financial management techniques, facilitating a financial wellness plan, and connecting them with community- based financial supports (e.g., free financial counseling). The intervention will be facilitated by trained peer coaches. The intervention will consist of three phases: (1) intensive; (2) intermediate; and (3) follow-up. The 6-week intensive phase will include 6 weekly group sessions and 4 one-on-one coaching sessions. The intermediate phase will consist of 3 biweekly group sessions and either 3 biweekly or 2 monthly one-on-one coaching sessions, based on participant preference. The follow-up phase will include 3 monthly group sessions and either 3 monthly or 6 biweekly one-on-one coaching sessions, also depending on participant preference. This study will obtain input from stakeholders to develop the intervention (Step 1), pilot it with a small sample of participants (n=10; Step 2), use this information to revise the intervention (Step 3), test it in a larger sample of individuals with financial hardship and suicide risk (n=48; Step 4), and prepare a final version of the intervention manual (Step 5). To date, the study has completed Steps 1-3. The main outcome of this study will be a manualized intervention to lessen financial hardship as a risk factor for suicide.

RECRUITING
iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes
Description

This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom.

Conditions
COMPLETED
The Impact of Family Financial Support on Parental Stress
Description

The investigators have partnered with financial coaching organizations to establish what the investigators have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on family economic strain and parental stress.

Conditions
ACTIVE_NOT_RECRUITING
Financial Incentives for Veteran Therapy Completion
Description

Recovery Resource Council (RRC) is one of the largest and most comprehensive non-profit mental and behavioral healthcare providers in North Texas. Accredited by the Joint Commission in Behavioral Health and licensed by the State of Texas as an Outpatient Treatment Center, RRC strives to promote wellness and recovery through a variety of services and programming. An important component of RRC programming is providing free counseling services to hundreds of U.S. veterans annually. While RRC observes great success for veterans who complete counseling, attendance can be a major obstacle. Veterans who approach RRC for individual counseling services and consent to participate will be randomly assigned to the treatment or control group. The control group will receive counseling as usual. The treatment group will receive $500 gift card payments upon completing their 6th, 12th, and 18th counseling sessions, i.e., $1,500 in gift cards for completing all 18 sessions, the usual prescribed length of therapy. Our primary focus is to examine the impact of the financial incentives on therapy attendance and attrition. In addition, the investigators will estimate the impact on mental health using mental health inventories collected over the course of therapy sessions.

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
The Impact of Family Financial Support on Parental Mental Health
Description

The investigators have partnered with financial coaching organizations to establish what the investigators have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on mental health using the Kessler-6 emotional distress scale.

COMPLETED
Impact of a Financial Success Education Program in Women and Children
Description

Many Americans are living paycheck to paycheck. This may lead to financial stress and an increase in overall stress. People under stress are more likely to smoke, consume alcohol, eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also increase the risk for heart disease. The purpose of this research study is to test whether participating in the Financial Success Program improves health outcomes, in both the women participating and their children.

Conditions
COMPLETED
Prolonged Exposure Therapy for PTSD and Opioid Use Disorder
Description

Among patients with opioid use disorder (OUD), 90% report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of OUD and PTSD is associated with worse mental health and opioid agonist treatment (OAT) outcomes relative to either diagnosis alone. Prolonged exposure therapy (PET) is an efficacious cognitive-behavioral treatment for reducing PTSD severity. Although preliminary findings indicate that PET may reduce PTSD symptom severity among patients receiving treatment for concomitant OUD, it is unclear to what extent improvements were a function of PET versus the effects of OAT itself. Therefore, the question of whether OAT alone may attenuate PTSD symptoms in the absence of intensive cognitive-behavioral therapy remains unanswered. In this 12-week trial, we aim to investigate the contribution of PET above and beyond OAT alone for reducing PTSD symptoms among adults with concurrent PTSD and OUD. Participants will be randomized to one of three conditions: (a) OAT as usual, (b) OAT + PET, or (c) OAT + Enhanced PET (OAT+PET+). Those randomized to OAT as usual will continue to receive standard buprenorphine or methadone treatment from their current treatment provider and complete assessments of PTSD symptom severity, psychosocial functioning and drug use at intake and Study Weeks 4, 8, and 12. In addition to receiving OAT and completing monthly assessments, OAT+PET participants will receive PET consisting of 12 weekly, individual sessions with a trained therapist. Finally, OAT+PET+ participants will receive the procedures noted above for the OAT+PET group plus monetary incentives delivered contingent upon completion of PET sessions. Given the poor PET adherence rates reported among patients with substance use disorders, the use of incentives will ensure that we evaluate PET effects among patients who receive a sufficient dose of therapy. The proposed study design will permit us to disentangle the effects of PET from the effects of OAT alone while also including experimental conditions that reflect real-world practice. Taken together, this project will produce important new scientific and clinically-relevant information related to the mechanisms through which OAT and PET promote reductions in PTSD symptomatology in a highly vulnerable clinical population.

RECRUITING
Evaluation of the Pomona Household Universal Grant (HUG) Program
Description

The City of Pomona is launching the Pomona Household Universal Grant (HUG) program in the Summer of 2024. Pomona HUG is a pilot project that will provide 250 parents/caregivers with children under 4 years old $500 a month for 18 months. Pomona's guaranteed income (GI) initiative provides relief for the most economically vulnerable households. The study will investigate the impacts of GI on financial security, material hardship, health and well-being, food security, social support, parenting, and childhood development. The intervention group will be compared to a control group of 350 parents/caregivers receiving only a nominal ($20) amount per month during the 18 month period.

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.