69 Clinical Trials for Various Conditions
The primary goal of this SBIR Direct to Phase II is to expand upon the existing training platform to create an "all-in-one" digital product, FBT 2.0, that offers an integrated suite of intervention components, including (a) dynamic, personalized, self-paced program for children and parent/caregivers; (b) e-training and ongoing support for interventionists; and (c) family engagement and monitoring tools for interventionists. Investigators will create a comprehensive, e-learning digital intervention with engaging, interactive, and personalized online tools for youth and their parents/caregivers that are integrated into the broader interventionist platform.
The goal of this SBIR is to develop and test Assist-MH, a new interactive digital support system for SMH providers. Assist-MH will offer an innovative interactive planning tool to help providers create a treatment plan customized to the student's specific needs. Based on inputs, the system will generate both provider-led MH strategies to optimize time spent with the student and self-paced digital strategies (video, game-based, interactive) for students to augment in-person treatment and provide unique between-session learning and practice. SMH providers will use Assist-MH to plan and assign individualized MH strategies as well as monitor student progress over time (completion and MH functioning).
The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention.
Investigators will conduct a randomized controlled evaluation of standard nutrition education vs. standard education + Nutri, and interactive clinical software that automates diet assessment and guides resident physicians through personalized and evidence-based diet counseling. Investigators will evaluate differences in resident-reported diet counseling competence and self-efficacy using survey measures. Investigators will evaluate skills using a simulated patient appointment and coding scheme described in prior work.
The goal of this clinical trial is to determine the effects of an app to reduce opioid and cocaine use when layered atop methadone treatment as usual among people using both opioids and cocaine. The main questions it aims to answer are: * Do people who use the app remain in methadone treatment longer than people who receive only treatment as usual? * Do people who use the app report using opioids and/or cocaine less often, and do they report better improvements in their quality of life, than people who receive only treatment as usual? * Does using the app more lead to better methadone treatment outcomes among people using the app? Participants in this study will be randomly assigned to receive either the app or methadone treatment as usual. Participants randomly assigned to the treatment as usual group will receive access to methadone services as normally provided, including scheduled access to medications, information about the consequences of opioid and other drug use, and any onsite services (including group based interventions and/or 12-step programs). Those randomized into the app-using group will receive all the same services as the treatment as usual group, but will also be given a phone with the app already installed, or will have the app installed on their existing phone if they already have one. At random times throughout the week, the app will ask participants to submit drug tests for opioids and cocaine, which participants will be able to do remotely without having to physically "go to" a testing site. For each test that demonstrates the participant hasn't used opioids or cocaine, the participant will be rewarded with money directly into a debit card. Participants will also be able to earn rewards for picking up treatment-related medications, attending onsite appointments, and other treatment-related activities.
Mental health disorders are one of the most challenging chronic conditions to identify, treat and manage. This is largely due to the fact that diagnoses are almost entirely based on the patient's recall of current and past subjective experiences of symptoms; and then further interpreted by a healthcare professional introducing multiple layers of information biases in the formulation of a diagnosis. Accordingly, mental health conditions remain prevalent with high rates of misdiagnosis, inappropriate treatment and delayed intervention. In light of the heterogeneity across and within mental health conditions, a personalized interventional approach holds merit, yet the tools to effectively track an individual's day to day objective and subjective experience needed to achieve an individualized care approach have not until recently existed. Digital technologies such as passive and active sensing from smartphones and from wearable devices are shedding light on the capabilities of tracking new objective measures of health that could translate to key symptoms of mental health conditions. 'Multimodal data' approaches are those that attempt to translate a variety of electrical signals from digital devices to relevant health outcomes. The combination of digital devices to detect multimodal measures of mental health symptoms offers a unique opportunity to take a ground up approach in understanding the fluidity of mental health symptoms occurring at the individual level that might lend insight into new phenotypes of mental health illnesses that could have a physiological underpinning. The Study Investigators aim to characterize the multiplexing and fluid nature of mental health symptoms across individuals experiencing mental health symptoms and conditions using digital tools (i.e., wearables and mobile apps) and additional context information collected from virtual study support calls. The Investigators hope to know how objective measures from sensor data translate to core symptoms, episodes and flares across mental health disorders, and develop new (or new applications of) machine learning anomaly detection approaches and determine whether anomalies in expected symptom portraits can be reliably detected and enhanced by the addition of objectively measured data.
The purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.
The current study is a randomized pilot trial to test the feasibility of a psychoeducational virtual reality experience to increase motivation for behavior change among children with overweight or obesity.
The purpose of this study is to evaluate whether a short interactive video game device is associated with performance on standard measures of attention and problem solving in patients with systemic lupus erythematosus(SLE). The study is also designed to see if playing the video game for four weeks improves attention and problem solving in patients with SLE.
This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.
This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.
The purpose of the study is to evaluate the effectiveness of Welch Allyn PanOptic Plus Ophthalmoscope with smartphone adaptor, and assess residents' opinions on acceptability and usability of the device and curriculum vs the conventional non-digital device used in current clinical practice.
The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is: • What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities? o Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition; Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful. Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes. Participants will complete the following tasks: * Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups. * Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes. * Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.
The purpose of this one arm pilot was to assess the feasibility and acceptability of REPS w/BANDS and evaluate for signals of improvement for depressive symptoms, anthropometrics, and muscular endurance. Participants completed a 12-week personalized in-home resistance exercise program that was delivered in real-time via a smart home video device along with a buddy system for peer support.
The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer. Participants will be randomized to either an intervention or control group. Outcomes such as symptom severity, quality of life, and resource use will be examined.
Rheumatoid arthritis patients being seen at one of the participating clinical sites in a U.S. network of community rheumatology practices who are starting treatment on adalimumab or upadacitinib will be enrolled into a 24-week study combining clinical data from physicians, self-reported patient outcomes from the ArthritisPower registry app, and activity and sleep data from a Fitbit wearable device. The primary objective of this study is: • Evaluate longitudinal associations between biometric sensor data (activity and sleep measures), physician-derived data (including clinical disease activity index (CDAI), Rheumatoid Factor (RF) lab results and other relevant biomarkers, current medications and disease duration), and patient-reported outcomes (PROs) (including PROMIS pain interference, physical function, fatigue, sleep disturbance, satisfaction with participation in discretionary social activities, and anxiety). The secondary objectives of this study are as follows: * Explore the reliability and predictive validity of biometric sensor data to classify changes in RA disease activity and associated symptoms, including PROs. * To assess adherence and predictors of adherence with use of biometric sensor * Assess/track changes in upadacitinib and adalimumab patients using combined physician, PRO and biosensor data.
The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.
The coronavirus disease 2019 (COVID-19) pandemic has uprooted conventional health care delivery for routine ambulatory care, requiring health systems to rapidly adopt telemedicine capabilities. The digital divide, has been well documented with lower rates of technology and broadband adoption among racial/ethnic minorities. Additionally, Black patients suffer a disproportionate burden of hypertension and cardiovascular disease. This study will implement a text-based home hypertension monitoring program among Black Medicaid patients with hypertension and cardiovascular disease (CVD) and compare its uptake to the currently available blood pressure monitoring program using the patient portal that is integrated into the electronic health record (EHR).
The Validation of a Digital Diet Method project is very innovative because it links three methods to address the gap in measuring food intake of HS preschool children. Data collection is based on EMA theory; participant burden is low, and the Food Image App decreases participant and staff burden even further. Data management and analysis are semi-automated and relies on advanced computer algorithms. A strength of this approach is its semi-automation, which allows us to leverage the strengths of human operators and computer automation.
The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Participants will then engage in the iENDURE intervention (described below) for 4 weeks. At the end of the intervention period, participants will complete another brief assessment of self-report measures and a qualitative interview about their experience with the program. Participants will be compensated for completing the baseline and post-intervention assessments
Under a grant from the Department of Defense's PD program, Dr. Morley's is investigating new approaches that 1) use "gamification"- applying rules of games like point scoring, achieving silver, gold or platinum levels and competition-- to increase physical activity in PD; 2) identify whether certain PD patient respond differently to gamification interventions than others.; 3) use readily and commercially available (including Fitbits) digital health technologies to perform all study activities remotely and enable a "touchless" study where patients don't have to come in person for any studies visits. The study is underway and actively recruiting.
The purpose of this study is to identify the independent and combined effects of two types of self-monitoring and two types of micro-interventions when combined with standard cognitive behavioral treatment for bulimia nervosa (BN) and binge eating disorder (BED). The primary aims of this study are (1) to evaluate the optimal complexity of Self-Monitoring and Micro-Interventions on eating pathology (at post-treatment and at 6 and 12-month follow-ups and (2) to test the hypotheses that the optimal complexity level of each component is moderated by baseline deficits in self-regulation. The secondary aim will be to test target engagement for each level of complexity for each component, i.e., to test whether higher complexity of each technological components is associated with better rates of therapeutic skill use and acquisition and that improvements in skill use and acquisition are associated with improvements in outcomes. A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that component complexities may partially depend on each other).
The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.
A digital intervention to provide supplemental infant feeding support to mothers enrolled in WIC. The trial begins prenatally and continues through 3-months postpartum and tests the feasibility and acceptability of a text messaging intervention aimed at increasing responsive bottle feeding as well as breastfeeding duration and exclusivity among mothers enrolled in WIC using evidence-based components such as interactive self-monitoring and feedback. Recruitment and enrollment never started at Duke for the Intervention represented in this record. The overall status of recruiting and actual start date were previously entered in error.
In an effort to personalize medical care, novel approaches have been used to categorize sub-populations of patients with type 2 diabetes (T2D). These are based on biological and genetic variables, allowing identification of clusters with significantly different clinical characteristics and risks of complications that may be more amenable to targeted and precise therapeutic interventions. Increasingly, wearable and other digital health technologies have the potential to capture additional and objective information to support personalized medicine but at present underserved populations have largely been excluded from clinical trials incorporating digital health. With this study, the Investigators aim to build on prior work using specially trained community health workers ("Community Scientists") to support engagement with an underserved population and to encourage adherence to using wearables and other digital health technologies. In the US, this is especially imperative for the Hispanic/Latino population, which is at high risk for T2D and associated complications.
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes.
This platform will enable investigation the cardiovascular risk reduction and the increase in participant engagement in their heart-healthy goals, through the use of virtual care/telemedicine with a digital platform that connects them to their own doctors, nurses, and dietitians.
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.
The purpose of this research study is to determine the influence of a regular yogic breathing practice on sleep, and to find out primarily if a regular practice of 8-week yogic breathing would enhance sleep quality as well as if it would improve participant's quality of life, and reduce existing stress. Study participants will be randomized into two arms for different breathing practices.
The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer is: which intervention is most effective in uptake of genetic testing for the target population? Participants will receive genetic testing and counseling that may initiate life-saving screenings.