Clinical Research Directory

Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

The Effect of Family Member Voices on Dopamine, Serotonin Levels, and Pain in Patients in Intensive Care Units

In intensive care units, the frequent use of analgesics leads to polypharmacy and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their quality of life. Listening to the voices of family members is expected to have positive effects on patients due to its ease of implementation, low cost, and non-invasive nature.

Data Science and Qualitative Research for Decision Support in the HIV Care Cascade

The goal of this study is to determine whether clinical prediction algorithms derived using statistical machine learning methods can be used to improve patient outcomes in large HIV care programs in sub-Saharan Africa and elsewhere. There are two main questions to be answered. First, can the prediction algorithms accurately identify those who are at risk for (a) missing scheduled clinic visits and/or (b) treatment failure, evidenced by elevated HIV viral load? And second, can the risk predictions be used in a structured way to (a) improve retention in care and/or (b) reduce the number of patients having elevated viral load? Researchers will develop machine learning prediction algorithms, incorporate the risk prediction information into the electronic health record, provide guidance to clinical health workers on use of the point-of-care interface tools that display risk prediction information, and incorporate feedback from clinic staff to modify and co-develop the protocol for using risk predictions for improving patient outcomes. They will then compare the proportion of patients having missed visits and longer-term loss to follow up, and the proportion with elevated viral load, between clinics that use the information from the risk prediction algorithms and those that do not.

Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes

The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.

Optimizing Cardiovascular Preventive Care for Women Following Hypertensive Disorders of Pregnancy

Cardiovascular disease is the leading cause of death among women in the United States, and women with hypertensive disorders of pregnancy have a 2-fold higher risk for cardiovascular disease later in life compared to women with uncomplicated pregnancies. This research investigates a patient-centered intervention during the postpartum period to promote engagement in cardiovascular preventive care.

At-home Breast Oncology Care Delivered With E-health Solutions

The COVID-19 pandemic has significantly impacted healthcare service delivery, highlighting the need for high quality virtual patient care. Our team has developed a multi-dimensional remote eHealth solution for newly diagnosed breast cancer patients and their practitioners to use during the diagnostic and follow-up period. The ABODE study involved development of a Breast Cancer Treatment Application (app) which will facilitate virtual consultations, deliver patient education material, and collect patient reported outcome measures (PROMs). Using a randomized controlled trial design, the team will evaluate a variety of outcomes for breast cancer patients who will use the app throughout their diagnosis and treatment period. Primary Objective: To compare changes in patient activation (assessed by PAM-13) over 1 year among newly diagnosed breast cancer patients between those using the app and those receiving standard care. Secondary Objectives: 1. Compare additional PROMs between the standard care and intervention groups 2. Describe health service outcomes among app users 3. Explore end-user experience of using the app 4. Measure activity levels using wearable devices

Patient Engagement in PTSD Treatment (PEP)

The goal of this clinical study is to improve the outcome of outpatient PTSD treatment at two clinics treating majority ethnic Danes and refugees with PTSD respectively. The study will consist of two similar randomized controlled trials. The main questions the study aims to answer are: * Does an added motivation enhancement module as a precursor for PTSD treatment reduce dropout and increase treatment outcome? * Does an added Shared Decision-Making session which facilitate individualized treatment yield a superior outcome compared to PTSD treatment and PTSD treatment supplemented by motivation enhancement? Participants are recruited at two different clinics, Psychotherapeutic Unit (PU) and Competence Centre for Transcultural Psychiatry (CTP). At PU the participants are randomized to one of two arms, and at CTP to one of three arms. One arm is the control group where participants will receive treatment as usual (TAU), one arm is the first intervention group where the participants will receive an Introductory PTSD module consisting of four sessions focusing on enhancing motivation for PTSD treatment, before continuing in TAU. The last arm is the second intervention group, which will only take place at CTP. Here the patient will receive the Introductory PTSD module followed by a session of Shared Decision Making, where the participant together with the MD decides which of four standardized treatment courses they will receive. The treatment for all patients will last between 8-13 months.

Virtual and Video Counseling Versus In-Office Counseling for Laparoscopic Hysterectomy

Compare preparedness for total laparoscopic hysterectomies between patients who undergo virtual visits and those who undergo in-office visits for pre-operative counseling.

Use of Back Support After Transfemoral Angiography

In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.

AI-Augmented Motivational Interviewing Training for Primary Care

This study will examine the impact of training primary care providers (PCPs) in motivational interviewing (MI) using artificial intelligence (AI) to augment the training process. MI is a patient-centered approach to engaging patients in their own care. There will be a control group and two intervention groups, with the intervention groups receiving a different amount of MI training. The hypothesis is that the AI-augmented MI training will result in improved patient outcomes, improved clinician wellbeing, and reduced behavioral manifestation of clinician biases. This mixed-methods project will also collect qualitative data from structured interviews and focus groups with participating PCPs to examine perceived facilitators and barriers to the use of the MI approach in primary care.

Melanated Group Midwifery Care (MGMC)

This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.

PREMs In Vascular SurgERy Enhancement Study

THE PROBLEM: Patient Reported Experience Measures (PREMs) ask patients about their healthcare service experience. It gives them a voice to share their views. PREMs allow healthcare providers (HCPs) to see where care is good, and where they could improve. Vascular surgery is a surgical speciality looking after people's blood vessels (arteries and veins). There is no PREM available for vascular patients. The research team want to create a PREM for this patient group. WHY IT IS IMPORTANT: A PREM allows HCPs to record and understand patients' experiences of their treatment. It gives patients a way to provide feedback on their healthcare experience. PREMs can help HCPs make changes to patients' care, identifying areas of good practice and areas for improvement. The Welsh Government is keen to support the use of PREMs. AIMS: To develop a PREM specific to vascular surgery patients. RESEARCH PLAN: The research team will summarise the literature about PREMs in surgery. The research team will then run focus groups and interviews with patients and staff to create a 'draft' PREM for vascular patients in Wales. The 'draft' PREM will be translated into Welsh. In the second phase, a larger number of vascular patients (100-300 depending on how long the 'draft' PREM is) from hospitals across Wales will complete the questionnaire. Statistical tests will look at the results to see if the questionnaire works well to capture patients' experiences. Based on these results, small changes will be made to make the 'draft' PREM better. This will make sure the 'final PREM' is ready for widespread use in Wales and beyond. PATIENT AND PUBLIC INVOLVEMENT: The patients' experience team at CAVUHB has reviewed our patients' materials. Our research team includes PPI co-applicants (DC and AH). DC a double amputee who has had many vascular operations. DC has experience raising awareness about vascular disease through public forums like the Limbless Association Charity and BBC Radio Wales. AH has issues with her leg due to smoking and had a keyhole operation to help with that. She had some problems after the procedure This is her first time as a PPI representative. DC and AH supported our research design and will be steering group members. Also, our research focuses on giving patients a voice and will include patients across Wales. A diverse group of patients will be involved across all stages of the PREM development.

Collaborative Open Research Initiative Study (CORIS-1)

The Collaborative Open Research Initiative Study (CORIS) is a groundbreaking international research endeavor aimed at exploring vital topics within the field of health professions education. At its core, CORIS embodies the spirit of inclusivity by opening its doors to contributors from all corners of the globe, putting the power of research into the hands of the global community and fostering an environment of open collaboration and meaningful contribution. We invite anyone and everyone to join as collaborators and suggest questions for inclusion in the survey, ensuring that the research process is enriched by diverse perspectives. As a collaborator, you will not only have the opportunity to actively engage in survey design, question formulation, and the entire research process from start to finish, but also gain the prospect of achieving valuable publications, which may boost your professional career.

Improving Access to Lung Cancer Clinical Trials

There are \~85,000 lung cancer patients (LCPs) in the UK; yet only around 8% were recruited into clinical trials in 2021/22. LCPs need opportunities to take part in clinical trials to access new treatments, increasing their quality of life, treatment choices and life expectancy. Discussions with nurses can help patients make better treatment decisions, improving experiences of care. However, research has shown that lung cancer nurses (LCNs) often feel unable to discuss participation in trials with patients due to lack of knowledge, confidence, time and training. This study aims to develop and test a research recruitment tool for LCNs, to support LCPs to enter clinical trials. Objectives include to: * Explore reasons for low uptake of LCPs into clinical trials * Develop a tool for LCNs to talk to patients about clinical trials * Test whether the tool improves the number and quality of discussions nurses have with LCPs about clinical trials The study has four phases: Phase 1: A literature review will identify problems that make clinical trial uptake difficult for LCPs, carers and clinicians Phase 2: Six group discussions with LCNs, patients and carers will explore issues that create potential barriers for patients taking part in clinical trials. The groups will take place online, last approximately one hour and be recorded. Phase 3: Part 1\&2 findings will help us develop a LCN research recruitment tool. The tool will contain information on how nurses obtain information about LC clinical trials, research teams, communication issues, practical issues and how to reach LCPs. Phase 4: The research recruitment tool will be tested in four UK NHS hospitals. A survey will identify any changes in nurses' clinical trials awareness and confidence before and after using the tool. Interviews with LCNs, patients and carers will explore their views on the tool, clinical trials participation and experiences of care.

Testing Design Thinking Methodology to Engage Hispanic and Latino Families of Autistic Children in Research.

The goal of this study is to compare the level of engagement in the Hispanic and Latino parents of autistic children and culturally adapt the protocol of Ayres Sensory Integration to improve participation and health outcomes. The main questions it aims to answer are: Does the Design Thinking process result in higher stakeholder engagement and satisfaction in the research process in comparison to Focus Groups? Secondary question: Do cultural adaption using DT data yield higher scores of acceptability and implementation feasibility in comparison to FG methods? Participants will: * Be randomized into two groups of engagement (focus groups and design thinking) * Be blinded (clinicians, selected caregivers, autistic persons, and cultural experts) and will rate the acceptability, feasibility, and cultural appropriateness of the protocol based on DT data higher than the protocol based on FG data.