Treatment Trials

173 Clinical Trials for Various Conditions

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RECRUITING
Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
Description

The investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called Let's Get REAL) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (SCTCT). The investigators will pilot the intervention among 24 youth and their parents, stratified by youth age (stratum 1, 8-12 years of age and stratum 2, 13-17 years of age).

RECRUITING
Persuasive Health Communication Intervention for HIV/HCV
Description

A major impediment to emergency department (ED)-based HIV/HCV screening success is that often ED patients at risk for, or later diagnosed with, HIV and HCV decline testing. In this R01 project, the research team will assess how well a promising, easy-to-use, one-time, minimal-training-needed, very brief persuasive health communication intervention (PHCI) increases acceptance of testing among adult ED patients who either currently, formerly or never injected drugs and initially declined HIV/HCV screening. The research team will conduct a randomized, controlled trial (RCT) at EDs within the Mount Sinai Health System to compare the efficacy of the PHCI when delivered by a video vs. an HIV/HCV counselor. Patients who initially declined HIV/HCV screening will be stratified by injection-drug use (IDU) history cohorts: (1) current/former PWIDs, (2) never/non-PWIDs. Within each IDU history cohort, the research team will randomly assign participants (1:1:1) to a PHCI delivered by: (1) a video with captions, (2) a video without captions, (3) an HIV/HCV counselor. This R01 project will be conducted at Mount Sinai affiliate hospitals EDs. For Aim 2, the research team will determine if screening acceptance is similar across IDU history cohorts. For Aim 3, the research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort.

COMPLETED
Women's Health Communication Study
Description

The central goal of this randomized, controlled pilot study is to examine the feasibility, acceptability, and preliminary effects of an educational intervention (called "Starting the Conversation"; STC) on patient communication about sexual health in gynecologic cancer and other patient health outcomes. Approximately 30 women with a diagnosis of gynecologic cancer will be randomized to either participate in either the Starting the Conversation (STC) condition, consisting of an educational video, workbook, and list of resources on sexual and menopausal health, or to a control condition offering the resource guide only. Patients will be asked to review intervention materials prior to their next clinic visit with their gynecologic cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being.

UNKNOWN
A Tailored, Health Communication Intervention for HPV Vaccine Hesitant Families
Description

The human papillomavirus (HPV) causes 90% of cervical cancers and is implicated in multiple other cancers. The HPV vaccine can prevent the vast majority of these cancers, but it is underused in adolescents, especially among those within vaccine hesitant (VH) parents. The proposed research is to develop and pilot test a tailored, health communication intervention aimed to increase HPV vaccination among VH parents. The proposed research is innovative because no evidence-based health communication interventions target HPV VH parents, and we will use stakeholder engagement throughout this study. The research will add knowledge on how tailored education provided before a doctor's visit can play a role in improving HPV vaccination rates among underserved, VH parents.

COMPLETED
Technology and Health Communication in Improving Health Outcomes in Patients Scheduled for Mammography
Description

This pilot clinical trial studies how well technology and health communication works in improving health outcomes in patients scheduled for mammography screening. The Mobile Mammography Screening Program provides a vital health service and it is important that all women scheduled for an appointment show-up to be screened. Technology and health communication may help decrease no-show rates among patients scheduled for mammography screening.

ACTIVE_NOT_RECRUITING
Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
Description

Adolescents and young adults (AYAs; ages 17-23) with type 1 diabetes are at high risk for negative health outcomes, including poor glycemic control and disengagement from the health care system. The deterioration of glycemic control occurs in parallel with the assumption of independent self-care skills and preparation for adult diabetes care. Effective communication between AYAs and health care providers may be a critical contributor to diabetes self-care skills during the transition to adult diabetes care and related glycemic control. This research will attempt to better prepare adolescents and young adults for adult diabetes care by delivering innovative intervention content focused on both health communication skills and transition readiness skills. The investigators aim to leverage innovative technologies to improve developmentally-appropriate communication skills related to planning for clinic visits, disclosing and discussing diabetes-related concerns, and optimizing glucose data review in preparation for adult diabetes care. Adolescents and young adults with type 1 diabetes (ages 17-23) who are planning to transition to adult diabetes care within the next 6-8 months will be enrolled in the study and randomized to either the intervention group or a standard care control group. Medical, communication and psychosocial data (including A1c, glucose monitoring frequency, communication quality, health care engagement, depressive symptoms) will be collected from adolescent and young adult participants and health care providers at baseline and two follow-up time points, approximately 4 months post-baseline and approximately 8-12 months post-baseline after the transfer to adult diabetes care. This intervention has the potential to improve diabetes self-care skills, including engagement with health care providers, and glycemic control in AYAs with type 1 diabetes during the vulnerable period of transfer to adult diabetes care. The results of this work will inform best practices for the transition to adult diabetes care and can be translated into clinical care.

TERMINATED
Patient-centered Approaches to Provider and Adolescent Reproductive Health Communication and Shared Decision-making
Description

Determine the effectiveness of an electronic self-administered pre-visit planning tool allowing adolescents to list areas of concern to support shared decision-making and communication during an office visit through a randomized controlled trial (RCT).

COMPLETED
Health Communication in Families
Description

There are two goals of this research study. First, we hope to develop a plan to guide family discussions that can help parents diagnosed with lung cancer talk about cancer risk with their adult children. Second, we want to understand how families talk about cancer prevention.

COMPLETED
Messages About Reduced Nicotine in Combusted Tobacco Products
Description

The investigators will conduct a message-exposure experiment with nationally representative samples of smokers, dual-users (cigarettes and e-cigarettes), and young adult non-smokers (aged 18-29). Experimental messages will address the reduction of nicotine in cigarettes. Participants will also complete a follow-up survey after 2 weeks, measuring their recall of the messages and behaviors since message exposure.

COMPLETED
Exploring Telehealth to Deliver Me & My Wishes During Coronavirus-19
Description

Due to Coronavirus-19, we are exploring the plausibility of delivering the Me \& My Wishes intervention via telehealth.

COMPLETED
Information Visualizations to Facilitate HIV-related Patient-provider Communication in New York City (Info Viz: HIV-NYC)
Description

To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using infographics. Data will be collected from participants through baseline (at enrollment) and follow up assessments at 3- and 6-month follow up visits). Follow up interviews will be conducted with members of the clinical team to ascertain their perspectives on the clinical utility of infographics.

COMPLETED
Me & My Wishes: An Efficacy Trial Using Videos
Description

The aim of this study is to determine whether the Me \& My Wishes intervention positively impacts communication of preferences among nursing home residents with dementia and their family caregivers and care team.

RECRUITING
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Description

The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.

COMPLETED
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
Description

This study tests the feasibility, acceptability, and preliminary efficacy of using a brief pamphlet in the primary care waiting room focused on promoting patient-initiated weight-related discussions in primary care appointments.

COMPLETED
Project to Improve Communication About Serious Illness--Hospital Study: Pragmatic Trial (Trial 1)
Description

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients 55 years or older with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1. To evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion in the period between randomization and 30 days following randomization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 7 and 30-day hospital readmissions. 2. To conduct a mixed-methods evaluation of the implementation of the intervention, guided by the RE-AIM framework for implementation science, incorporating quantitative evaluation of the intervention's reach and adoption, as well as qualitative analyses of interviews with participants, to explore barriers and facilitators to future implementation and dissemination.

COMPLETED
Patients Engaged in Prevention: Enhancing Outreach to Increase Patient Engagement in Diabetes Prevention
Description

This study examines whether a health message that includes a self-affirmation intervention (where people reflect on values that are important to them) increases acceptance of the message and encourages people to take steps to prevent diabetes, as compared to a health message without the self affirmation intervention.

RECRUITING
Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
Description

The overarching goal is to develop and demonstrate proof-of-concept of ReSPECT (Reproductive and Sexual Health Patient Education and Communication Tool), a multi-modal communication intervention to improve adolescent and young adult (AYA)- clinician sexual and reproductive health (SRH) communication in the outpatient oncology clinic setting.

RECRUITING
Leveraging Video Logs as a Bridge to Pre-exposure Prophylaxis (PrEP) With Tailored Messaging to Black Women and Their Healthcare Providers in Texas.
Description

The primary objective of this R34 proposal is to increase willingness for PrEP initiation and PrEP initiation among Cisgender Black Women (CBW) and increase willingness to prescribe/refer pre-exposure prophylaxis (PrEP) to CBW among healthcare providers (HCPs) in Houston/Harris County, a high priority Ending the HIV Epidemic (EHE) jurisdiction.

Conditions
NOT_YET_RECRUITING
Communicating About Nicotine Reduction in Cigarettes
Description

The goal of this clinical trial is to learn how a messaging campaign about reduced nicotine cigarettes and policy, combined with the use of very low nicotine cigarettes (VLNCs), affects smoking behavior and attitudes among adult smokers. The study also aims to assess the efficacy of the messages in different populations, including smokers with past-month serious psychological distress (SPD), low socioeconomic status (SES), and those in neither category. The primary hypothesis is: exposure to messages in combination with VLNC use will lead to less cigarettes use compared to VLNCs without messages. Researchers will compare: The effects of receiving VLNCs with messages (treatment group) to receiving VLNCs without messages (control group). Participants will: Complete a baseline survey and be randomly assigned to one of two groups: treatment (VLNCs + messages) or control (VLNCs only). Attend weekly study visits for surveys, breath samples, and receive supply of VLNCs , either with or without the messaging campaign. Complete brief daily surveys through text messages.

NOT_YET_RECRUITING
Testing Different Anti-smoking Messages Among Chinese Young Adult Smokers and Nonsmokers
Description

Young adults are particularly vulnerable to psychological distress during the transition from adolescence to adulthood, making them more susceptible to developing persistent substance use. The tobacco industry capitalizes on this vulnerability by using marketing tactics to promote tobacco initiation and facilitate the progression from experimental tobacco use to long-term use. In China, where the average age of starting daily smoking is 21.1 years old, the number of current young adult smokers exceeds 29 million. It is crucial to develop effective communication messages to counter the tobacco industry's marketing strategies and protect the health of young adults in China. This project aims to test the effects of different anti-smoking message themes among Chinese young adults. In this online randomized clinical trial, participants will be randomly assigned to one of five antismoking message conditions. The investigators will compare the effects of these themes with each other and with the control condition.

RECRUITING
Nicotine and Tobacco Message Framing to Change Smoking Behavior in Diverse Groups of Young Adult Smokers
Description

This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.

RECRUITING
M-Well Bonding Bundle to Improve Patient-Physician Relationships
Description

The goal of this clinical trial is to learn more about the interaction between a patient in the hospital and their treating doctor. A good relationship between patients and their doctors can help improve patient care. Doctors will be asked to use strategies to improve their interactions with patients in the hospital. The main questions it aims to answer are: * Will using the intervention strategies improve doctors' empathy towards their patients? * Will using the intervention strategies lead to improved scores in patient views of doctors' empathy? There will be 2 study arms. One group of doctors will be asked to use the intervention strategies. The other group of doctors will provide care as they would normally. Researchers will compare the doctors in the intervention arm to those in the control arm. Doctors are the primary subjects for this study. The doctors in both study arms will be asked to do the following: 1. Allow study staff to observe the interaction between them and their patients. 2. Complete a brief survey at the end of their 2-week work rotation. Doctors who are in the intervention arm will be asked to use suggested strategies when visiting with patients in the hospital. Patients are secondary subjects for this study. Patients of participating doctors may be asked to do the following: 1. Allow study staff to observe the interaction between them and their doctors. 2. Complete a brief survey after meeting with their doctor.

RECRUITING
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Description

The purpose of this clinical trial is to learn whether existing treatments for posttraumatic stress disorder (PTSD) can be improved. Two treatments for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) will be studied. CPT and PE are effective treatments that are widely available, but interventions are needed to improve patient outcomes in these treatments. The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health communication strategies to enhance CPT and PE by improving communication between patients and therapists about patients' experiences in treatment. This research will investigate whether adding AWARE to CPT and PE will lead to better treatment outcomes compared to CPT and PE provided as usual without AWARE. AWARE includes a brief writing task asking patients about their experiences in treatment, as well as guided therapist responses to improve patient-therapist communication about patients' experiences in treatment. In the first phase of the study (case series phase), CPT or PE with AWARE will be provided to four adults with PTSD to pilot test adding AWARE to CPT and PE, seek patient and provider feedback, and refine AWARE. The first four participants who enroll will be part of the case series and will receive CPT or PE with AWARE. Then, in the second phase of the study, the randomized controlled trial (RCT) phase, the investigators will enroll 50 more adults with PTSD who will be randomly assigned (like flipping a coin) to receive CPT/PE as usual or CPT/PE with AWARE. It is expected that 25 participants will be randomized to CPT/PE with AWARE and 25 participants will be randomized to receive CPT/PE provided as usual. The goals of the RCT phase are to study whether AWARE is acceptable to patients, whether it is feasible to add AWARE to CPT and PE, and whether adding AWARE to CPT and PE improves patient-therapist communication and treatment outcomes compared to CPT/PE as usual.

ENROLLING_BY_INVITATION
Choose It and Use It: Choice, Implementation Intentions and At-Home Colorectal Cancer Screening
Description

The goal of this study is to improve use of colorectal cancer screening among screening eligible African Americans who are served by Federally Qualified Health Centers in Michigan. The main questions it aims to answer are: * To what extent to individual prefer and select to complete screening with colonoscopy versus stool-based (FIT Kit or sDNA) options? * Can full completion of (i.e. follow-through with) screening with a selected modality be enhanced by delivery of a culturally targeted intervention? Participants will learn about colonoscopy, FIT Kit and sDNA as recommended and widely used screening options. Participants will select a modality to complete their own screening with. Participants will then be randomized to one of three arms (usual care, standard intervention, culturally targeted intervention). Researchers will compare the extent to which intervention arms enhance completion rates across each of the three screening modalities.

COMPLETED
Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva
Description

This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. This iteration will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.

COMPLETED
Impact of E-Cigarette Prevention Messages on Adolescents
Description

The purpose of this trial is to determine whether a vaping prevention text message program reduces susceptibility to vaping among adolescents and young adults. This study addresses this issue by exposing participants to a vaping prevention text message program over a 28-day period in a randomized controlled trial with a matched attention control condition. A follow-up assessment is also made 4 weeks after the text messaging ends.

Conditions
COMPLETED
Nicotine and Tobacco Message Framing Among LGBT Young Adults
Description

This trial refines and evaluates how cultural targeting influences the effectiveness of anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine how cultural targeting can be applied to communicate polytobacco use risk to at-risk LGBT young adults.

COMPLETED
Effects of Sugary Drinks Counter-marketing Messages
Description

This study aims to examine consumer responses to traditional and counter-marketing messages discouraging sugary drink consumption, including effects on intentions to consume sugary drinks and perceived weight stigma. Because prior research has suggested that counter-marketing may be especially effective among younger populations, the investigators will examine effects overall and by age group (young adults \[ages 18-29 years\] vs. middle and older adults \[ages 30+ years\]).

COMPLETED
Understanding Factors in Decision Making for Children with Medical Complexity
Description

The goal of this clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. The objective of this study is to identify the most effective ways to communicate decision-related risks and benefits to improve the quality of caregiver decision making for children with medical complexity. Participants will view a video of a simulated clinic visit and related medical information and complete a survey about their experiences. Researchers will compare participant survey responses to see if decision quality changes based on the information reviewed by the participant.

ENROLLING_BY_INVITATION
Study to Understand Risk Information to Support and Empower
Description

The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.