Clinical Research Directory

Comparing Original Patient Educational Materials vs. AI-Simplified Materials to Improve Patient Comprehension and Health Literacy

Poor health literacy and patient comprehension have been associated with adverse health outcomes. Patient educational materials (PEMs) are articles that are intended to assist patients in their understanding of a given medical condition. Given that the average American adult reads at the 8th grade level, the American Medical Association and the Center for Disease Control recommend PEM be written at the 6th grade level. However, literature has found the majority of PEMs to be written significantly higher than the 8th grade level. In order to improve their readability, a number of studies have displayed the effectiveness of large language models (LLMs) such as ChatGPT to simplify the text of a given PEM. Despite the improvement in readability, the effectiveness of these simplified PEMs on improving patient comprehension of the AI augmented material has yet to be investigated. The purpose of our study is to test whether the improvement in readability found in AI-simplified PEMs corresponds to a greater understanding of the material compared to the original PEM. Understanding if AI-simplified PEM truly improves comprehension could further support this use case for AI and aid providers and healthcare organizations in improving the health literacy of their patients. This study aims to answer the following question: Do AI simplified PEMs improve the comprehension of pediatric orthopaedic conditions? Researchers will compare AI-simplified PEMs to their original, unmodified counterparts in order to see if there is any difference in post reading comprehension of the participants. Participation in the study will include: * A brief baseline survey (e.g. demographics and educational attainment) * A randomly assigned reading of either the original PEM or the AI simplified version. * A 10 question post-reading multiple choice quiz

The Effect of Women's Heart Health Awareness Program

The aim of this study is to examine the effect of a gender-specific heart health protection awareness program, incorporating video-supported reminder messages, on knowledge, attitudes, practices (KAP) regarding cardiovascular diseases and health literacy among adult women aged 20 to 64 with no prior diagnosis of cardiovascular disease. The centers where the study is conducted will be divided into intervention (n=4) and control (n=5) groups using cluster randomization. While the intervention group receives a heart health awareness program consisting of three sessions in total, including education, risk factor screening, and individual counseling over a period of three weeks, the control group will receive standard of care. Data will be collected at the beginning of the first session and after the completion of the final session.

Cancer Literacy Education and Awareness Resources for Prostate Care

The CLEAR-PC project addresses the critical issue of low health literacy in prostate cancer prevention and care, recognising that inadequate health literacy leads to difficulties in understanding complex medical information, limits shared decision making, and increases health inequalities. Given the high prevalence and complexity of prostate cancer, the project aims to design and development of a comprehensive strategy to improve health literacy in the Prostate cancer prevention and care, considering individual capacities, the role of healthcare professionals and organisations, and the influence of social and cultural contexts. In the design and development of this new strategy, the investigators apply both action research and cocreation methodologies because by involving all stakeholders (general population, vulnerable population patients, health professionals, policy makers and other target groups), we ensure that the resulting strategy is user-centred, implementable and responsive to their needs. The design and development of the new strategy will follow a systematic cycle: (a) problem diagnosis by assessing individual contexts, healthcare professionals, organisational aspects and the social framework; (b) adaptation of existing health literacy tools to the specific context of prostate cancer prevention and care, integrating them into a new strategy, followed by evaluation of their usability and acceptability; and (c) observation of results in practice and reflection. Co-creation will be a critical component throughout this process, ensuring that stakeholders are actively involved at every stage, from diagnosis of challenges to refinement and validation of solutions. The consortium, composed of institutions from Spain, Portugal, Croatia, Belgium, the Netherlands and Cyprus, leverages multidisciplinary expertise to create digital and non-innovative tools and educational resources to address public health disparities, reduce misinformation and support decision-making on prostate cancer prevention and care.

Addressing Food Insecurity: Plant-Based Food Prescription Program

Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.

Effectiveness of Integrated Network for Student Psychosocial Intervention, Resilience, and Education (INSPIRE) on Mental Health Outcomes Among Indonesian Adolescents in Bandung

The INSPIRE (Integrated Network for Student Psychosocial Intervention, Resilience, and Education) intervention is an 8-week, school-based mental health program designed to enhance adolescents' mental health literacy and resilience while addressing symptoms of depression and anxiety. Implementation is conducted by school counselors who undergo an intensive two-day training program. The intervention is supported by comprehensive curriculum materials including detailed lesson plans, activities, discussion prompts, and instructional slides featuring key concepts, visuals, and explanatory content. Supplementary materials are developed for both participating adolescents and their parents. The study aims to: 1. Evaluate the usability and feasibility of the INSPIRE intervention within the school environment. 2. Assess the intervention's effectiveness in improving: * Primary outcome: Mental health knowledge among adolescents * Secondary outcomes: Attitudes toward mental health, help-seeking behaviors, mental health literacy, resilience, and symptoms of depression and anxiety among adolescents * Secondary outcomes: mental health knowledge, attitudes, help-seeking behaviors, and mental health literacy among parents 3. Explore the experiences of intervention participants (both adolescents and parents) against the control group to develop comprehensive insights into the psychosocial intervention's impact. The research hypothesis proposes that the INSPIRE intervention group will demonstrate significantly higher scores in mental health knowledge, more positive attitudes toward mental health, increased help-seeking behaviors, enhanced mental health literacy, and greater resilience, while simultaneously showing reduced symptoms of depression and anxiety compared to the control group receiving standard care. These outcomes will be measured immediately following the intervention (post-test 1) and at one-month follow-up (post-test 2).

Determinants of Primary Care Health Professionals' Numeracy Skills and Practices and Association With Patient Health Literacy and Quality of Care

To enable appropriate risk representation for patients, health care professionals (HCPs) must have a personal understanding of quantitative data. To date, a limited number of studies on physicians' numeracy skills and practices show that, although physicians perform better than the general population, not all physicians have mastered basic numeracy skills. Low numeracy among physicians was associated with lower quality adherence to good practice recommendations, inaccurate inferences about test results and side effect risks, and reluctance to share numerical information with patients. The primary objective will be to explore the determinants of the objective numeracy level of primary care professionals. A cross-sectional survey will be conducted on a sample of primary care professionals practicing in the west of Occitanie (former Midi-Pyrenées region). Objective numeracy will be measured using the Adaptive Berlin Numeracy Test (ABNT) and the Abbreviated Numeracy Scale, whereas subjective numeracy will be assessed using the Subjective Numeracy Scale (SNS-3). The Health Literacy Questionnaire (HLQ) will be used for patients.

Open Space and Closed Years

The primary objective of this project is to examine the effects of a specific multicomponent physical activity program (MPAP), conducted in an outdoor setting, on the health and functional-motor status (HFMS) of women over the age of 60. Additionally, the study will investigate the influence of sociodemographic factors (SDF), physical literacy (PL), and health literacy (HL) on the baseline HFMS and the subsequent changes resulting from the KTP. Study Methodology The program participants will consist of older women (\>60 years; n=60) whose current HFMS allows for participation in the exercise protocol. They will be divided into two groups: Experimental Group: Will participate in the MPAP. Control Group: Will not participate in the MPAP. The exercise intervention (MPAP) will include a combination of aerobic activities, strength exercises, balance, and flexibility. It will be conducted two to three times per week across two three-month cycles, separated by a three-month break. Data Collection and Environment Assessments: Sociodemographic factors, physical literacy, and health literacy will be measured at the start of the study. A series of HFMS indicators will be recorded before and after each exercise cycle. Setting: The MPAP will be performed outdoors in a public park. Project Significance Beyond analyzing the direct effects of the exercise program and the correlations between the measured variables, this project will contribute to a deeper understanding of the importance of the natural environment in implementing goal-oriented physical activity for the elderly population.

Evaluation of the Effectiveness of Health Literacy Education Given to Women by Teach-Back Method

This study aims to enhance women's health literacy levels and to examine the effectiveness of the teach-back teaching technique in improving women's health literacy. The research was designed as a randomized controlled study. In addition, this study aims to answer the question of whether health literacy education delivered using the teach-back method is effective in improving women's health literacy levels. Within the scope of the study, participants in the experimental group will receive health literacy education using the teach-back technique, while the control group will receive standard care. Data will be collected using a questionnaire method.

The Fit With Us Study

The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.

The Impact of Medical TV Drama in Improving Literacy on Neurocysticercosis

This randomized controlled trial evaluates whether exposure to a medical television drama improves knowledge of neurocysticercosis (NCC) among young adults. Sixty participants aged 18-35 will be randomly assigned to either an intervention group, which will watch a medically relevant TV episode (House M.D., Season 1, Episode 1), or a control group with no media exposure. Both groups will complete pre- and post-test questionnaires assessing knowledge of NCC. The primary outcome is change in NCC-related knowledge. Secondary outcomes include motivation to seek further health information and perceived credibility of the media source

Cocreating Action to Improve Rationality in the Health System

Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity. The scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis. The goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.

Health Literacy Levels of Patients Living With Type 2 Diabetes and Multi-disease and Their Families Using HLQTM

This study aims to identify health literacy strengths and needs among people living with type 2 diabetes and multi-disease and their family members.

Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative

Effective patient education improves health literacy and engagement thus improving long-term health outcomes. Health literacy is imperative to make informed health decisions and relies on the ability to obtain, process and understand health information; and is the cornerstone of safe health management. It is necessary to evaluate educational initiatives to determine their effectiveness in knowledge translation. A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patient teaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required. Electronic KITE teaching modules are infographic visual representations that present information quickly and clearly, integrating words and graphics to tell a story to reveal information. Infographic presentations are tools which facilitate self-directed learning with understandable, accessible information presented in an engaging way with an aim to enhance learning for children and their families. Patients are able to learn at a pace consistent with their learning style to facilitate knowledge development and health literacy.

Nurse-Led Telehealth for Gout

The aim of this clinical trial is to evaluate whether nurse-led telehealth support helps individuals with gout better manage their condition and adhere to urate-lowering medication after discharge from a rheumatology clinic. Eligible patients will be recruited from five rheumatology departments in the Central Denmark Region after achieving two consecutive target serum urate levels-below 0.36 mmol/L, or below 0.30 mmol/L for patients with tophi. Participants will be adults with gout who meet specific medical criteria, are taking medications such as allopurinol or Adenuric, and are able to read and write Danish. Participants will be randomly assigned to one of two groups: * Intervention group: nurse-led telehealth support. * Control group: usual care with follow-up by their general practitioner. The primary goal is to support patients in maintaining healthy uric acid levels after 52 weeks. Participants in the nurse-led group have the option to choose from four support options: I1: App-Based Support - an app provides information and reminders. I2: Letter Reminders - messages are sent via digital or postal mail. I3: Text Reminders - SMS messages are sent every three months. I4: Phone Support - nurses call three times a year to check in.

From Health Information to Health Decisions Integrating Mindfulness Into Digital Learning and Daily Life

This research project aims to explore how combining e-health literacy with mindfulness practices can help university students navigate the complex landscape of e-health information and make more informed, healthier choices. Specifically, the study will assess the current levels of e-health literacy, food literacy, and media literacy among university students, and examine how these factors are related to critical thinking, decision-making confidence, and overall well-being. The project will involve a 4-arm design, including: (1) a mindfulness group, (2) an e-health group, (3) a mindfulness + e-health Group, and (4) a Control Group. Participants in the intervention groups will engage in short mindfulness exercises focused on mindful eating and movement during break times and cool-down sessions of their Physical Education (PE) classes. Additionally, digital health content (e.g., videos and articles) will be provided to enhance e-health literacy. This could lead to better-informed, more confident students who are able to make healthier choices in their daily lives, both during their university years and into the future. Study Aim To evaluate the effectiveness of an 8-week intervention delivered during PE classes, comparing the effects of: 1\. Mindfulness Group 2. E-health Group 3. Mindfulness + E-health Group 4. Control Group The intervention will assess changes in students' e-health literacy, food literacy, media literacy, critical thinking, self-compassion and decision-making self-efficacy over time, with assessments at pre-test, post-test, and 4-week follow-up. Study Hypotheses: 1. Students in the mindfulness group, e-health group, and combined group will show significantly greater improvements in all outcome measures from pre-test to post-test compared to the control group. 2. The combined group will demonstrate the greatest gains in literacy and cognitive outcomes, due to the additive effect of both interventions. 3. Improvements will be maintained at the 4-week follow-up, particularly in the combined group.

Health Literacy and Self-efficacy Expectations in Patients With Alcohol-related Liver Cirrhosis

The goal of this observational study is to quantify the health literacy and self-efficacy in people with alcohol-related liver cirrhosis.

Multimodal Radiology Report to Improve Patient-centered Radiology

The goal of this study is to learn if AI-generated video explanations help people better understand their radiology reports. The main question it aims to answer is: Do AI-generated videos help participants understand their medical imaging results better than written reports alone? Participants will send their own radiology images and written reports to the research team; receive a personalized AI-generated video that explains their results in easy-to-understand language; watch their video explanation (about 1-5 minutes long); and complete 15-minute online survey about how well the video helped them understand their results.

Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare

Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.

Health Literacy in the Perioperative Setting

The purpose of this study is to determine the association of the social determinants of health with perioperative health literacy in caregivers of children presenting for surgery. Another purpose is to determine the association of caregiver health literacy with preoperative caregiver anxiety and postoperative patient pain scores.

Education and Literacy for an Active Life (Educação e Literacia Para Uma Vida Ativa)

Health literacy is essential for children to develop healthy behaviors that persist into adulthood. It enables the access, understanding, evaluation, and application of health-related information, being a key component of health education. This study was designed as a randomized controlled study, aiming to analyze the effectiveness and feasibility of a school intervention to improve health literacy of 5th and 6th grade students on nutrition, physical activity, sleep, and mental health. Intervention will be delivered in two phases. Phase 1 will involve a pilot intervention comprising four sessions conducted over a three-month period in two schools representing distinct socioeconomic contexts. Phase 2 will scale the intervention nationally, expanding to include additional schools across Portugal. This phase will include eight sessions conducted over one entire school-year (September-June), and will integrate adjustments based on the limitations and insights identified during the pilot study. Phase 2 will additionally include 20-month follow-up assessments to be performed at the end of the following school-year (20-month).

Learn to Act - Promoting Mental Health Literacy in Chronic Pain

This pilot randomised controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of an intervention program promoting Mental Health Literacy. A 10-week group treatment, 90 minutes each session, for adults and older adults with Chronic Pain. Half of the participants will receive the intervention immediately (experimental group), while the other half will not receive it initially. Still, they will receive it after the main phase of the study is completed (control group in waiting list). The intervention focuses on increasing Mental Health Literacy and reducing maladaptive beliefs and behaviours associated with pain. It also explores mechanisms and moderators of change.

Health Literacy in Geriatric Patients

Health Literacy is one's ability to understand health information well enough to make informed decisions about their health. Limited health literacy makes it hard for people to understand complex health issues and follow health care recommendations. Limited health literacy is associated with adverse health outcomes such as higher mortality, increased risk of emergency department visits and hospital admissions leading to higher medical costs. Although there are tools to assess health literacy, they are not widely used, so many healthcare providers do not measure their patients' health literacy levels adequately. Health care workers tend to overestimate their patients' health literacy. This is especially important for older adults who often have memory problems and multiple illnesses. This study will evaluate how doctors and team members in a geriatric clinic estimate their patient's health literacy and determine if this matches with the patients' health literacy as measured by a simple validated questionnaire. The investigators will also look at how a patient's relative or caregiver estimates their health literacy using a similar short questionnaire. The research team plans to follow up with a telephone call in 6 months, to see which health concerns if any have occurred since the clinic visit.

Health Care Transition Readiness Short-Form Video Intervention

The goal of this clinical trial is to assess whether social-media style short-form health education videos can increase health care transition readiness, self-efficacy, emotional well-being, health literacy, and appointment attendance, compared with publicly available health education resources in adolescents with chronic illnesses. The main question it aims to answer is: -Hypothesize social media intervention will increase health care transition readiness, self-efficacy, emotional well-being, health literacy, and appointment attendance compared to publicly available health education website immediately post intervention and at 6 month follow up. Participants will be randomly assigned to one of the interventions and access the intervention for 20 minutes and complete 30-60 minutes of surveys.

Adolescents' Health Literacy, Physical Activity and Healthy Eating Self-efficacy Levels

Adolescence is a critical transitional period characterized by rapid and multifaceted changes in physical, psychological, and social dimensions. According to the World Health Organization, adolescence encompasses the age range of 10 to 19 years. Alongside physical changes, this period involves significant developments and transformations in knowledge, skills, and behaviors, driven by the individual's identity formation process. Health behaviors such as nutrition and physical activity play a pivotal role in protecting and promoting adolescent health. However, unhealthy eating habits and insufficient physical activity are highly prevalent among adolescents. These behaviors are associated with physical problems, including obesity, diabetes, hypertension, cardiovascular diseases, delayed growth and development, and psychological issues such as susceptibility to stress, low self-esteem, and lack of confidence. Consequently, fostering healthy eating and physical activity behaviors in adolescents is essential. Given that adolescents spend a considerable portion of their time in school, implementing school-based interventions to promote these behaviors represents an effective approach to preventing lifestyle-related health issues in adulthood. The literature indicates that various interventions aimed at improving nutrition and physical activity behaviors in adolescents are generally effective. Nevertheless, sustaining these behaviors in the long term remains a challenge, as studies have shown that increases in knowledge do not always translate into behavioral changes. One of the most effective strategies for instilling healthy behaviors in adolescents is health education. School-based health education not only facilitates the acquisition of functional health literacy but also strengthens the attitudes, beliefs, and practical skills necessary for adopting and maintaining healthy behaviors. Moreover, health education is a powerful tool for enhancing health literacy components such as accessing, understanding, evaluating, and utilizing accurate health information, enabling adolescents to take responsibility for their health and make informed decisions. This study aims to contribute to fostering healthy eating and physical activity behaviors in adolescents, supporting their transformation into lifelong habits. Additionally, the findings are expected to guide school health professionals, particularly school nurses, in expanding interventions within the scope of school health services.