Clinical Research Directory

Feasibility Study of a Relaxation and Guided Imagery Intervention Research Protocol for Use in School Settings.

The goal of this study is to gather information that (1) will be used to determine whether or not a research protocol for investigating the efficacy of a relaxation and guided imagery intervention for improving K-12 students' social-emotional, behavioral, and learning outcomes is feasible for use in school settings and (2) can be used to refine the research protocol.

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic

The goal of this clinical trial is to learn whether virtual reality (VR) can be added to routine knee injection appointments at a VA outpatient pain clinic without slowing down or disrupting clinic operations. The study will enroll 45 adult veterans who are scheduled for a knee injection at the Atlanta VA Arcadia pain clinic. The main questions it aims to answer are * Can a VR headset be set up and used during a knee injection with minimal time disruptions? * How many patients agree to take part, how many need to stop using the headset early, and how satisfied are patients and clinicians with the experience? Researchers will compare patients who wear a VR headset during their injection to patients who receive the usual injection without VR. This will show whether VR may change anxiety, time spent thinking about pain, satisfaction, and memory of the procedure. Participants will: * Be assigned by chance to one of two groups. Two out of every three participants will use VR, and one out of every three will receive usual care only. * If in the VR group, wear a headset showing a virtual environment with little motion. A research team member will place the headset before the needle goes in and remove it after the injection is finished. * Receive their scheduled knee injection as usual from their clinician. * Complete a short survey right after the procedure. Taking part happens during one clinic visit and takes about 30 minutes. The knee injection itself is standard care and is not changed by the study.

Pilot Study of a Behavioral Program for Depression in Skilled Nursing Facility Residents and Care Partners

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and care partners. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 8 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

PROtective Ventilation With FLOW-Controlled Ventilation

The investigators want to investigate in patients undergoing robot-assisted laparoscopic surgery (a minimally invasive procedure) how applicable flow-controlled ventilation is, and whether it might also be safer than the current ventilation techniques, as well as its impact on potentially reducing the risk of lung-specific complications. Flow-controlled ventilation has already been tested in several studies on animals and humans and has proven to be a safe form of ventilation for patients undergoing surgery under general anesthesia. When patients undergo major surgery, general anesthesia is required and, as a result, mechanical ventilation of the lungs. Especially in long and complex surgeries, ventilation can become more difficult or lead to complications postoperatively. These patients may then experience shortness of breath, coughing, or require medication to improve lung function. In some cases, reintubation or additional mechanical ventilation may be necessary for support. Previous human studies have shown that flow-controlled ventilation is less stressful and, therefore, potentially safer for the lungs compared to traditional ventilation techniques, and that less supplemental oxygen is required. This effect and the safety of flow-controlled ventilation have been demonstrated in several studies. Therefore, in this study, the investigators aim to explore whether flow-controlled ventilation is potentially safer and easier to apply than traditional ventilation techniques and whether it can reduce the risk of lung-specific complications following robot-assisted surgeries, thereby improving the recovery process postoperatively.

Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 6 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality in College Students: A Pilot Study

The goal of this single-arm feasibility, pilot study is to assess the feasibility, acceptability, and potential effectiveness of the Herbs and Spices Nutrition Education Program (HSNP-focusing on incorporating herbs and spices into the diet for adherence to the DGA's) for determining the scalability of implementing this intervention for a larger scale, more comprehensive study The main questions it aims to answer are: * What is the feasibility and acceptability of incorporating herbs and spices into the diet along with DGA-focused nutrition education through the HSNP in college students with poor dietary quality? * What are the preliminary effects of the HSNP on dietary intake/quality, cardiometabolic, and gut health in college students with poor dietary quality? * What are the barriers associated with HSNP implementation in college students with poor dietary quality? Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the clinical study site for a Pre-HSNP and Post-HSNP Study Visit (within two weeks prior to starting the HSNP and after week 6 of completing the HSNP) for assessments of cardiometabolic and gut health. * Be asked to come to the Nutrition Center for weeks 1 and 3 of the HSNP, where they will receive education on the Dietary Guidelines for Americans and the health benefits of herbs and spices, have a sensory evaluation of foods, be provided budget-friendly recipes and resources, and given take-home herbs, spices, and supporting materials * Be asked to complete 3-Day Food Records throughout the 6 week study period for assessment of dietary quality (4 total)

PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.

The study investigators aim to test an online support platform for Michigan youth aged 8-18 years enrolled in elementary, middle, or high school and their parent/caregiver. The online support platform will be hosted on the Computerized Intervention Authoring System (CIAS) 3.0 and will provide evidence-based cognitive behavioral coping skills for physical (pain) and mental (stress, mood) health symptoms, with additional substance use prevention content for youth aged 12 and older. Evaluations will occur at baseline and then a post assessment approximately 8 weeks later.

Automated ABPI in Peripheral Arterial Disease a Pilot Study

The aim of this pilot study is to investigate the diagnostic accuracy of two automated ABPI devices across the spectrum of PAD (asymptomatic PAD, suspected symptomatic PAD \[IC; including mild moderate and severe IC based on the Rutherford classification (21) and CLTI\] and post-bypass surveillance). A second aim is to assess their useability and tolerability through semi-structured interviews with patients and clinicians. This means the research will be split into two workstreams.

Study on the Association Between the Introduction of Complementary Feeding and Infant Gut Microbiome Composition

The goal of this observational study is to assess the feasibility of investigating the association between the introduction of complementary feeding and gut microbiome composition in infants. The main question it aims to answer is: Can we reach the feasibility targets for questionnaire completeness and data quality, the proportion of stool samples suitable for analysis, protocol adherence, and recruitment rate? Parents will complete questionnaires about their infant's health and nutrition and collect stool samples from their infant at three timepoints around the introduction of complementary feeding.

HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG

Typically, PET scans involve an IV injection of 18F-FDG that helps identify cancer. Patients are scanned 60 minutes after injecting 18F-FDG. This study aims to assess the feasibility of a different method of administration - oral ingestion (rather than IV) of 18F-FDG through delayed imaging to identify the optimal time for scanning after consuming the drug. The study will aim to recruit 15-24 individuals who will receive two PET scans - one using delayed oral 18F-FDG imaging and a second regular 18F-FDG. The analysis will focus on establishing a suitable protocol for this administration route while considering patient preference and image quality.

Building Capacity and Healing: A First Nations-led Study of Education for Psychedelic-Assisted Therapy

Building Capacity and Healing: A First Nations-Led Educational Pathway for Psychedelic-Assisted Therapy is an educational initiative led by the First Nations Health and Social Secretariat of Manitoba (FNHSSM). The goal of this clinical trial is to learn if a First Nations-led, culturally grounded education program for psychedelic-assisted therapy is feasible and acceptable by health practitioners working within First Nations communities. The main questions it aims to answer are: * Is a First Nations-led educational and culturally grounded intervention feasible in a land-based setting? * Do participants complete the intervention and follow-up assessments? * Does a First Nations-led program improve acceptability and knowledge comprehension of psychedelic-assisted therapy? Researchers will compare quantitative and qualitative data from those in the intervention who receive land-based training compared to virtual training modules to see if it improves acceptability, adherence, and knowledge comprehension. Participants will acquire a full medicine bundle (spiritual, ethical, cultural, and scientific knowledge) through land-based teachings with respected Elders and Knowledge Keepers. No medicine administration occurs in this study.

Digital Support Strategies for Caregiver Home Practice

This project is a pilot trial of the Engaging Families home practice smartphone application (or "app") as an add on to a family-based prevention program. Although there are many evidence-based preventive interventions delivered to caregivers to prevent youth substance use and mental illness and promote youth positive family and youth outcomes, the impact of these interventions is often limited by low home practice of intervention skills among caregivers. The Engaging Families home practice app is a digital behavior change intervention that was developed to support caregivers in practicing intervention skills at home. Researchers will ask participants if the app was acceptable and feasible for daily use at home. Researchers may also compare how often caregivers who use the study app do home practice of intervention skills compared with caregivers who do not receive the home practice app but are encouraged to use an app to help schedule their activities.

Feasibility of a Modified Dental Comfort Position for Pediatric Patients Receiving Dental Exams

The goal of this study is to learn if a modified bottom-to-bottom comfort position is a feasible alternative to the traditional knee-to-knee position during dental hygiene examinations for patients aged 12 months to 5 years. In the modified position, the patient sits in their caregiver's lap and reclines their head on the dental chair, allowing for both parental contact and dental provider access to the patient's mouth. This study will also examine the modified position's impact on the patient's distress and cooperation during the exam, parental satisfaction, and provider perception. The main questions are: Is the modified comfort position a safe and feasible alternative for young children undergoing dental hygiene exams? How does the modified comfort position impact patient completion rate and dental exam duration? How does the modified comfort position impact patient distress and cooperation, parental satisfaction, and provider acceptability? Participants will: Utilize the modified comfort position with the guidance of a Certified Child Life Specialist. Undergo a routine dental hygiene exam. Answer survey questions about parental satisfaction and patient psychological and developmental diagnoses. Dental providers will answer survey questions about acceptability and feasibility.

AI-Based Personalized Exercise Prescription Through Mobile Health on Physical Activity and Health Outcomes in Older Adults: A Feasibility Study

The purpose of this research is to investigate the feasibility, acceptability, appropriateness, and preliminary efficacy of a wearable and artificial intelligence-driven mobile application-based exercise prescription grounded in self-determination theory (SDT) and behavioral change techniques (BCTs) among older adults. As no data exists on the feasibility of AI-driven exercise programs grounded in SDT and multiple BCTs specifically for older adults, this will be a pioneering study to explore the feasibility of wearable and AI-driven exercise program protocols and the rates of acceptance and appropriateness of the exercise prescription intervention among older adults. In addition, this study will test the preliminary efficacy of the intervention on physical activity (PA), mental health, and quality of life. This study follows the National Institute of Health (NIH) stage model, and it represents stage 1b of the NIH stage model, which emphasizes the feasibility and actionable processes for delivering a new health intervention. Specifically, this study will: 1.Evaluate the research protocol feasibility of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs (of goal setting, self-monitoring, graded task, and demonstration) on older adults over 8 weeks 2. Evaluate the acceptability and appropriateness of a wearable, AI-driven, mobile application-based exercise prescription grounded in SDT and BCTs among older adults over 8 weeks. 3. Evaluate the preliminary impact of a wearable and AI-driven mobile application-based exercise prescription grounded in SDT and BCTs on older adult PA (steps per day and daily duration of light PA and Moderate-vigorous PA), sedentary time, sleep, mental health (depression and anxiety), and quality of life.

Feasibility of the Reality PAWS Program for Children in Isolation

The goal of this clinical trial is to learn if a mixed reality program, Reality PAWS, delivered on a Meta Quest 3 VR headset, is a feasible intervention for pediatric patients in isolation. It will also evaluate the safety of the program and its effect on pain, anxiety, and loneliness. The main questions the study aims to answer are: What is the feasibility of utilizing Reality PAWS MR as a substitute for in-person dog therapy for children under isolation precautions? Are patients compliant with using Reality PAWS MR? What are the interventional outcomes of Reality PAWS MR? Participants will: Wear a Meta Quest 3 VR headset with the Reality PAWS program. Interact with the program. Answer surveys regarding demographics, anxiety, pain, loneliness, sickness, perceived exertion, and immersion in the program.

The Increasing Mindfulness Engagement Project

The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application. 1. Does receiving text messages increase engagement in a mindfulness app? 2. Does an integrated gaming app increase engagement in a mindfulness app? Researchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they engage in additional gaming app on their smartphone. Participants will: 1. Use a mindfulness and gaming mobile health application for 28-days. 2. Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.

Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward

The goal of this feasibility study is to explore the use of wireless continuous vital sign monitoring in an orthopaedic setting among orthopaedic nurses and patients undergoing adult spinal deformity surgery. In addition to the standard care National Early Warning Score the participants in this study will be monitored by CPC12S a wearable sensor that is worn on the chest using electrodes measuring electrocardiography single lead (ECG), Heart rate, respiratory rate, SpO2, blood pressure and temperature. Main hypotheses: The use of wireless continuous vital sign monitoring in daily clinical practice for patients undergoing ASD surgery is feasible in terms of increased acceptability among orthopeadic surgical nurses measured over 12 months with a response rate of at least 80% with an average score of ≥5 at the last measurement in each of the four dimensions of the USE questionnaire: Usefulness, ease of use, ease of learning and satisfaction. The following parameters will be evaluated: Primary outcome: 1. The feasibility in terms of acceptability of the concept of wCVSM among orthopedic surgical ward nurses. Secondary outcomes: 2. The feasibility in terms of acceptability of the concept of wCVSM in patients undergoing ASD surgery. 3. The technical fidelity of wCVSM, assessed by data collected of vital signs, display of alerts to staff nurses and response to the alerts. 4. The frequency of vital sign deviations in patients after ASD surgery using wCVSM compared to NEWS2. 5. Clinical outcomes of patients undergoing ASD surgery including surgical complications, reinterventions, ICU admissions, unplanned ward transfer, and admissions to another department.

THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility)

THRIVE-Belize is a school-based program being developed to support the health and well-being of adolescents in the Toledo District of southern Belize. The program covers seven topics: communication and emotional regulation, healthy expressions of masculinity, sexual and reproductive health, healthy relationships, mental and physical health, substance use prevention, and environmental health. Before testing whether the program works, the research team needs to learn whether students, teachers, parents, school staff, and community members find it acceptable, appropriate, and practical to deliver at Toledo Community College. This study (Phase I) does not deliver the program to anyone. Instead, it gathers feedback through surveys, focus groups, and interviews with about 280 participants across these five groups. The information collected will be used to refine the program and decide whether to move forward to a future pilot study. No medical or educational intervention is given to participants in this phase.

A Psychomotor Group Intervention for Young Adults With Anxiety Symptoms

The goal of this clinical trial is to learn if a psychomotor (a body-oriented therapy) group intervention can be feasibly delivered to a group of young adults (age 18-35) with anxiety symptoms within a higher educational setting. The main questions it aims to answer are: * Is it possible to recruit and retain participants in this intervention? * Is the intervention acceptable and tolerable to participants? * Do participants complete the planned sessions and assessments? Participants will: * Attend one weekly group session over ten consecutive weeks * Participate in active and contemplative body-based exercises * Complete questionnaires about their mental health and interviews about their experiences of participating

Optimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial

Up to 40% of patients experience suboptimal recovery in the days following major surgery, limiting their return to functional independence. Few preventive interventions exist, but intravenous dexmedetomidine and lidocaine administered during general anesthesia represent simple strategies that may significantly impact recovery and other patient-centred outcomes after surgery. The goal of this pilot trial is to determine the feasibility of conducting a phase 3 pragmatic adaptive multicentre trial to evaluate the impact of dexmedetomidine and lidocaine administered during major non-cardiac surgery on patient-centred outcomes.

Physical Activity Intervention for Older Family Carers

The goal of this pilot trial is to learn whether a six-month physical activity program tailored for older family caregivers can be successfully delivered and whether participants are willing and able to take part in it. The study will also explore possible effects of the programme on physical activity, physical function, health, and well-being. The main questions it aims to answer are: * Can enough participants be recruited to the study? * Do participants adhere to the study and complete follow-up assessments? * How often do participants take part in the program activities? * How acceptable and useful do participants find the program? * What are the possible effects of the programme on physical activity, health, and wellbeing. Researchers will compare the physical activity program with a control group that receives health information and education about healthy ageing. Participants will: * Complete health, physical functioning, and questionnaire assessments at the beginning of the study, after 6 months, and after 12 months * Wear an activity monitor on their wrist for 7 days and nights at the beginning of the study and after 6 months * Will be randomly assigned to either a six-month physical activity program designed for older family caregivers, or a control group that receives health information and education about healthy ageing. * If assigned to the physical activity program, participants will take part in weekly group-based and remote exercise sessions for 6 months. * Provide feedback about their experiences of the program

Evaluation of a Multi-Component Intervention to Support HIV Testing and Linkage to Services Among MSM in Peru

This study is testing a new program designed to improve access to HIV testing and help connect people with available treatment or prevention services, based on their test result. The version of the program being tested in this study was designed for men who have sex with men (MSM) in Lima, Peru. The program has two main parts: 1) offering HIV testing at venues where people go for sex (called "sex-on-premises venues" or SOPVs), and 2) a text messaging app that shares useful information about HIV treatment/prevention; users can also message back to get support from a healthcare worker. Before doing this study, the researchers worked with community members and healthcare providers in the area to make sure that the HIV testing approach and mobile app were designed in a way that would be engaging and meet their needs. Every Thursday, Friday, and Saturday night during recruitment, the researchers will go to SOPVs popular among the MSM community in Lima and invite people to take an HIV test. On each recruitment date, they will offer one of the following HIV testing options: 1. A rapid HIV test done on-site (participants will get their result right away) 2. An HIV self-testing kit to take home 3. A coupon for a free HIV test at a participating health center 4. Their choice of any one of the previous three options Only one of these options will be offered at a time, depending on the date. The specific HIV testing option offered on each date will be randomly assigned. All participants will receive the mobile app, which will send weekly messages with links to different types of online content (infographics, maps, videos) over the next 3 months. The specific sequence of messages and content will be different depending on the type of HIV test the person received and their HIV test result, once it is known. The study will measure two main outcomes related to the acceptability and feasibility of the program: * The number and percentage of people who accept the program when offered * The number and percentage of participants who continue to engage with the mobile app after 3 months The study will also measure: * overall satisfaction with the app (based on a questionnaire sent at 3 months) * the number and percentage of participants who completed any form of HIV testing after 3 months * the number and percentage of participants who started HIV treatment (out of those with a positive HIV test) * the number and percentage of participants who started HIV pre-exposure prophylaxis, or "PrEP" (out of those with a negative HIV test) All follow-up will be done remotely. Participants will have the app for 3 months. After 3 months, they will get a follow-up questionnaire asking about their experiences with the program. The researchers will keep tracking results related to the HIV treatment/prevention services that people receive for up to 6 months.

Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

The goal of this interventional study is to assess the feasibility of two bedside techniques for confirming central venous catheter (CVC) placement and detecting complications: * Intracavity ECG monitoring to confirm internal jugular vein CVC tip position. * Thoracic point-of-care ultrasound (POCUS) to rule out pneumothorax following CVC insertion. Participants who require an internal jugular CVC as part of their routine care and meet all inclusion and no exclusion criteria will be randomised to receive either: * Standard care, or * The intervention, consisting of intracavity ECG guidance and thoracic POCUS. The CVC will be inserted either on the left or right side of the neck. All participants will undergo a post-procedure chest X-ray regardless of study arm, to allow comparison of the intervention methods with standard care.