Clinical Research Directory

School-Based Mental Health Education on Mental Health Literacy Among Adolescents

The goal of this clinical trial was to learn whether a single interactive mental health education session improves mental health literacy among senior high school students in a remote area on the Indonesia-Malaysia land border (Sambas Regency, West Kalimantan, Indonesia). The main question was whether students who attended the session would score higher on the Mental Health Knowledge Questionnaire immediately afterwards than students who received a printed leaflet, after accounting for their scores before the activity. Researchers compared intact classes that attended the session with classes that received a printed mental health leaflet. Participants completed the questionnaire before the activity, then either attended one face-to-face session of about 60 minutes or received the leaflet, and completed the same questionnaire again immediately afterwards on the same day. This record was registered after data collection had been completed.

My Symptoms Young - a New Internet-based Programme for Young People With Persistent Physical Symptoms in Primary Care: Exploration of Effect and Health Literacy Characteristics Among Users

The research programme is an ambitious effort aiming to improve overall functioning and quality of life for young people with bodily distress. Bodily distress is a condition characterized by persistent physical symptoms (PPS), such as headache, nausea or abdominal pain, not explained by a well-defined disease. Over time, PPS can develop into a functional disorder, with detrimental impact on the young person's everyday life and opportunities. Thus, early intervention is crucial, but at present, access to specialized treatment of PPS to young people in primary care is very limited. The investigators have developed the internet-based self-help programme My Symptoms Young as a new digital solution for early intervention of PPS. The intervention was developed using a high degree of user involvement (young people with PPS) and are now ready to be tested. The goal of this clinical trial is to learn and preliminary test the possible effects of the internet-based self-help intervention program My Symptoms Young in young people aged 15-25 who experience PPS (physical symptoms presenting for \>3 months). The main question the investigators aim to answer is: * What are the potential effects of My Symptoms Young In addition, the investigators aim to investigate if participation in the program can reduce overall symptom intensity and interference with daily activity in young people's lives. Finally, the investigators aim to examine if individual levels of health literacy (HL) and eHealth literacy (eHL) will modify the potential effects. * The primary outcomes will be symptom intensity and symptom interference with daily activities * The primary hypothesis will be: Symptom intensity and interference with daily activities will improve after the treatment with My Symptoms Young. The effect will be modified by levels of HL and aspects of eHL. The investigators will include a total of 62 participants. The are no comparison group. Participants will be recruited from a health care professional in primary care (either general practitioner or practising pediatrician; from now on referred to as HCP). The HCP will determine whether referral to the My Symptoms Young programme is relevant. To guide this evaluation, the HCP will use pre-defined inclusion and exclusion criteria for participation. When a young person has been referred to the project group, a research assistent from the investigator group will contact the young person to provide more detailed information on the research project and the programme. If written consent is obtained, the young person will receive access to the programme. Throughout the intervention, the referring HCP is fully responsible for the health care of the young person. Referral and participation will be documented in the participants' primary care medical journal. If participants experience physical or psychological challenges during the project, they are advised to contact the referring HCP, i.e. the responsible healthcare provider. The programme is accessed through a website, using either tablet, mobile or computer. It consists of seven modules, a closing module on relapse prevention, and a module targeting close relatives plus four tools: don't break the chain, goal setting staircase, symptom registration and notebook for reflections. The seven modules target symptom understanding, physical energy, resources and strains, thoughts, feelings, values, and self-care. Participants will gradually gain access to the modules. The programme encourages young persons to work with various exercises throughout the different modules but with freedom to choose what to work with. Besides text and exercises, the programme also includes explanatory animations, audio files on case stories, audio files on brief meditations and videos on physical exercises. At first login (baseline), the participant will need to complete a set of questionnaires to access the programme. When completed the participant receives access to the programme. The researcher will follow up with participants by phone after one week if they have not logged into the programme and after three weeks if they have logged in but remained inactive. Participants can decide individually how long they wish to use the programme, but they are encouraged and recommended to engage actively at least twice a week for a minimum of 30 minutes. Participants will have access to the program for a total of 8 weeks. They will fill in questionnaires at three time points: Baseline (first login to the programme), End of Treatment (8 weeks after baseline) and 3 months after End of Treatment.

MEST : A School- Based Health Literacy Intervention Trial

The purpose of this study is to evaluate the effectiveness of the MEST work strategy in upper secondary schools. MEST is a school based, health promoting intervention delivered by school health services and designed to strengthen students' health literacy and mental well being. The study assesses whether implementation of the MEST work strategy results in improved health literacy and mental well being compared with usual school health services. This study is a pragmatic matched-pair cluster-randomized, parallel-group superiority trial in which upper secondary schools are assigned either to an intervention group implementing the MEST work strategy or to a control group continuing with school health services as usual. Student-reported outcomes are collected using digitally administered questionnaires during school hours at baseline (T0), and at 4-month (T1) and 9-month (T2) follow-up assessments following intervention initiation. Baseline data collection was conducted between August and October 2026.

Designing a Large Language Model Architecture for Shared Decision Making and Informed Intentions

This study investigates a novel, agentic Large Language Model (LLM) architecture designed to facilitate Shared Decision-Making (SDM) in healthcare. While patients increasingly use standard LLMs for health information, these models often struggle with multi-turn conversations and fail to adapt to varying reading levels, disadvantaging vulnerable groups. By utilizing an agentic state-machine, this project aims to overcome common LLM deficits-such as context loss and uncritical agreement-to ensure clinically accurate, participatory patient conversations. The study evaluates whether this architecture improves informed decision-making compared to standard LLMs, particularly for patients with low health literacy.

Mobile Assisted Education on Prenatal Health

This study aims to evaluate the effect of mobile-assisted education on prenatal health literacy, health behaviors, and childbirth outcomes among primigravida women

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.

Podcast-supported Education on Climate Change Awareness, Anxiety, and Health Literacy Levels in Nursing Students

The study was designed with a parallel-group randomized controlled experimental design to determine the effects of podcast-based education on climate change awareness and climate change health literacy levels of nursing students. A podcast-based climate change awareness education will be implemented as the study's intervention. Participants in both groups will complete a pre-test. The experimental group will then receive four sessions of podcast-based climate change awareness education, while the control group will receive no intervention during this phase. After the four sessions, both groups will complete a post-test simultaneously. Subsequently, participants in the control group will receive the same four-session podcast-based educational intervention. Following completion of these sessions, both groups will complete a follow-up assessment at the same time. Hypothesis 0-1: There is no difference in the level of climate change awareness between the experimental group receiving podcast-based education and the control group. Hypothesis 0-2: There is no difference in the level of climate change anxiety between the experimental group receiving podcast-based education and the control group. Hypothesis 0-3: There is no difference in the level of climate change health literacy between the experimental group receiving podcast-based education and the control group.

AI-Simplified Discharge Summaries to Improve Patient Comprehension (ContextCare)

This randomized pilot study will compare standard hospital discharge communication with discharge summaries simplified using ContextCare, an artificial intelligence-assisted application. The study will enroll 50 adults discharged from Scarborough Health Network. Participants will be assigned to one of two groups in a 1:1 ratio, with allocation stratified by baseline health literacy. The main measure is how well participants explain their diagnosis, treatment, follow-up care, and instructions for seeking further help immediately after receiving discharge information. The study will also assess satisfaction, recall after discharge, and selected post-discharge outcomes.

Gamified Interactive Narrative (REPRO-QUEST) on Sexual Health Literacy and Sexually Transmitted Infection Prevention Behaviors

This randomized controlled trial evaluates the effectiveness of an analog gamification-based interactive narrative intervention (REPRO-QUEST) on enhancing sexual health literacy and behaviors aimed at protecting against sexually transmitted infections (STIs) among female university students. Participants in the intervention group participate in the REPRO-QUEST interactive narrative game session, while participants in the control group receive standard evidence-based educational material on sexual health and STI prevention (an Educational Booklet). Sexual health literacy and protective behaviors against STIs are assessed at baseline and post-intervention to evaluate the efficacy of gamified learning compared to standard educational materials.

The Health Literacy for Healthier Mind Study

Health literacy is critical for patient safety, quality of care, and long-term health outcomes, yet health professionals often lack the support, time, and tools to deliver health literacy-sensitive care (health literacy sensitivity is the knowledge, skills, and attitudes health professionals require to effectively meet patients' health literacy needs). Building on a successful feasibility study showing that a targeted intervention can enhance health literacy sensitivity and teamwork without harming mental or occupational well-being. The Health Literacy for Healthier Minds study will build on these positive results and test a scalable, multi-component intervention in four Norwegian hospitals. The study aims to strengthen health professionals' health literacy sensitivity, safeguard their mental and occupational well-being, and explore patients' experiences with health literacy-sensitive care.

Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )

Life Skills Training is a school-based prevention program aiming at promoting wellbeing and at preventig use of substances. It has a version for middle school and another for primary school students. The LST-Primary has been evaluated evaluated in US with partially positive results. Regione Lombardia decided to translate and adapt the LST-Primary program for the Italian population. In a first time, involving the US developers, the program has been translated and adapted to Italian students. The present study is aimed at evaluating the effectiveness of the program adopting an experimental design and a random allocation of the condition.

Development and Reliability and Validity Testing of a Health Literacy Assessment Scale for Nursing Assistants

The goal of this observational study is to develop and evaluate a health literacy assessment scale for caregivers (nursing assistants) working in medical institutions, based on their job characteristics and caregiving needs. The main questions it aims to answer are: Can the newly developed scale validly and reliably measure health literacy among caregivers in healthcare settings? What is the current level of health literacy among caregivers, and which factors are associated with it? Caregivers working in medical institutions (aged 18-65, with at least 3 months of caregiving experience) will complete survey questionnaires about their health literacy, health behaviors, and job characteristics. A subset will repeat the survey 14 days later to assess test-retest reliability.

Online Sleep Education for College Student's Sleep Health and Executive Functioning

The goal of this clinical trial is to determine if asynchronous psychoeducational sleep intervention works to improve college students' levels of self-reported sleep health literacy, sleep quality, and executive functioning. The main questions it aims to answer are: Can an educational sleep intervention improve college students' sleep health literacy and sleep quality? Does improved sleep health literacy impact sleep quality? Does improved sleep improve executive functioning in a college student sample? The hypotheses of the present study include the following: * College students with poor sleep quality will have lower executive functioning * College students who participate in a brief educational sleep intervention will have more improvements in sleep health literacy compared to college students who do not * College students who participate in a brief educational sleep intervention will have more improvements in sleep quality compared to college students who do not * College students who participate in a brief educational sleep intervention will have more improvements in executive functioning compared to college students who do not. Researchers will compare the intervention group to a wait-list control group to see if college students who watch the psychoeducational sleep intervention have more improvements in sleep quality, sleep health literacy, and executive functioning than those who do not. Participants will: * Complete a pre-intervention survey * Respond to a post-intervention survey six weeks after the pre-intervention survey * Be randomly assigned to watch a 30-to 45-minute psychoeducational sleep lecture video either during the pre-intervention survey or after the post-intervention survey

On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women

This randomized controlled study will evaluate whether a hybrid health literacy education program improves sexual function and digital health literacy in postmenopausal women. Hybrid education combines in-person and online sessions. The study will include 128 women aged 45-60 years who have not had a menstrual period for at least 12 months. Participants will be recruited from the gynecology and obstetrics outpatient clinic at Kahramanmaraş Sütçü İmam University Hospital in Türkiye and randomly assigned to an education group or a usual-care group, with 64 women in each group. The education group will receive a midwife-led program consisting of one in-person session and two online sessions over three weeks. The sessions will cover sexual health during menopause, finding and evaluating reliable online health information, and using this information in daily life. Women in the usual-care group will continue to receive routine health services without additional study education. Participants in both groups will complete questionnaires assessing sexual function and digital health literacy before and after the intervention period. Researchers will compare changes between the groups to assess the effects of the education program.

Health Literacy, Rational Drug Use, and Cyberchondria in Rheumatic Diseases

Purpose: This study aimed to evaluate rational drug use (RDU), health literacy (HL), and cyberchondria levels among individuals diagnosed with inflammatory rheumatic diseases, and to investigate the factors associated with these three key health-related variables. Methods: This research was designed as a cross-sectional study and conducted between December 2024 and May 2025. The study enrolled three cohorts: a case cohort comprising patients diagnosed with rheumatic disease as patient group (group 1); a disease control cohort of knee osteoarthritis (group 2), and a reference control cohort of age- and sex-matched healthy participants (group 3). Disease Activity Score 28 (DAS28) was administered to patients with rheumatoid arthritis; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was administered to patients with ankylosing spondylitis; Psoriatic Arthritis Disease Activity Index (DAPSA) was administered to patients with psoriatic arthritis; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) was administered to patients with knee osteoarthritis; and Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Turkey Health Literacy Scale-32 (THLS-32), Rational Drug Use Scale (RDUS), and Cyberchondria Severity Scale (CSS) were administered to all participants. Results: The study sample consisted of 228 participants, with 76 individuals assigned to each of the three groups. Mean age, and gender distribution were similar in all three groups. Statistically significant variations were observed across the three groups regarding THLS-32, RDUS, and CSS scores (p \< 0.001). Group 1 had the highest HL and RDUS scores, and moderate CSS scores. In contrast, Group 2 showed the lowest HL and RDUS scores, while Group 3 demonstrated the highest CSS scores. HL was positively correlated with RDU (r = 0.552, p \< 0.001), and moderately negatively correlated with cyberchondria (r = -0.448, p \< 0.001). These results indicate that higher HL is associated with more rational medication behavior and reduced susceptibility to online health-related anxiety. (p\< 0.001). Conclusions: To our knowledge, this is the first study to simultaneously investigate RDU and CSS in individuals diagnosed with RA, AS, and knee osteoarthritis. Our findings demonstrate that higher levels of HL are significantly associated with more appropriate medication behaviors and lower levels of internet-related health anxiety. These results emphasize the multidimensional role of HL, not only in promoting RDU but also in mitigating maladaptive digital health information-seeking patterns.

Improving Health Literacy on Chronic Kidney Disease Among Diabetics: the Malaysian Nutritional, Emotional and Physical Health Literacy for Optimal Renal Outcome (My-NEPHRO) Trial

The goal of this clinical trial is to learn if a health literacy module via mobile application intervention can improve health outcomes and health literacy in diabetics with chronic kidney disease and could include any of the following: diabetic patients with non-dialysis chronic kidney disease aged more than 18 years old. The main questions it aims to answer are: 1. Are there differences in health literacy between intervention and control group at pre- and post-3 and 6 month exposure to the health literacy module in both intervention and control groups 2. Are there differences in quality of life scores between intervention and control group at pre- and post-3 and 6 month exposure to the health literacy module in both intervention and control groups? 3. Are there differences in renal function(eGFR) and HbA1C in pre- and post- 6 month exposure to the health literacy module between the intervention and control groups? Researchers will compare with normal care to see whether the effect of this intervention is larger than the effect of usual care in improving health literacy and HbA1c level, and impact towards renal disease progression and quality of life in diabetics with chronic kidney disease. Participants will be instructed to access the mobile application weekly.

Digital Health Education to Improve Cardiovascular Health Across Different Socioeconomic Groups: e-DUCASS Advance

The e-DUCASS Advance study is a randomized study evaluating whether a 24-month digital health education program can improve cardiovascular health among people living in Córdoba, Spain, and representing different socioeconomic backgrounds and areas of the city. Approximately 600 participants aged 12 to 79 years will be enrolled. Participants will be assigned by family so that members of the same family remain in the same study group. All participants will first receive an initial basic health education workshop covering healthy eating, physical activity, sleep, tobacco use, and other health-related behaviors. Families will then be randomly assigned to one of two groups. The control group will receive no additional educational intervention, whereas the digital intervention group will receive weekly educational content through a web-based application or messaging channels. This content will include short videos, infographics, knowledge assessments, motivational activities, and access to support. Cardiovascular health will be assessed at baseline, 12 months, and 24 months using the American Heart Association's Life's Essential 8 score. This score evaluates diet, physical activity, nicotine exposure, sleep, body mass index, blood lipids, blood glucose, and blood pressure. The study will compare changes in cardiovascular health between the two groups and examine whether the effect of the program differs according to the socioeconomic characteristics of the participants' areas of residence. Other assessments will include adherence to a Mediterranean lifestyle, health and nutrition literacy, physical activity and sedentary behavior, chronotype, quality of life, anxiety, and depression.

Impact of AI Care Summaries on Caregiver Comprehension

The primary objective is to assess if an AI-generated plain language summary of an inpatient progress note can improve caregiver understanding of their child's hospitalization by measuring differences in Hospital Course Comprehension scores, based on their responses to a survey regarding their child's hospital course. Secondary objectives include exploring the caregiver's perspective on the use of AI in clinical care, as well as 7-day and 30-day readmission rates, 7-day and 30-day emergency department (ED) re-utilization rates, length of stay, and environmental impact measures.

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.

AI-enabled Communication to Advance Research Engagement (AI-CARE)

The objective of AI-CARE is to train researchers and community members to use artificial intelligence (AI) to create plain-language summaries of research studies and to determine whether a co-creation process for developing these summaries improves understanding and relevance of the research, confidence in AI and in institutions, and AI literacy. The hypothesis is that AI-generated research summaries, co-developed with researchers and community partners, will significantly improve confidence in research and institutions, understanding and accessibility of the research, and appropriateness of the summary compared with standard researcher-generated materials, and that the educational and co-creation process will build community members' AI literacy and confidence in using AI, as well as researchers' readiness to use and comfort with using AI for communicating research.

Senior Center Medication Safety and Empowerment Curriculum

Team Alice's Medication Safety and Empowerment Curriculum (MedSEC) helps older adults and caregivers learn how to safely manage medications. Many seniors take multiple medications, which can lead to harmful side effects or unnecessary treatments. This program, developed at the University at Buffalo, will be offered at senior centers in Western New York. It includes two interactive sessions that teach participants how to recognize medication risks and talk with their doctors about safer options. The curriculum uses videos, group discussions, and hands-on tools to build confidence and knowledge. It follows the "4Ms" of Age-Friendly Health Systems: What Matters, Medication, Mentation, and Mobility. A "Train-the-Trainer" model will help senior center staff continue the program long-term. The goal is to reduce medication harm, improve communication with healthcare providers, and support healthy aging in the community.

Patient AI Trust Dynamics Before and After Orthopedic Consultation (ORTHO-OP-GPT)

Patients increasingly consult artificial intelligence (AI) chatbots such as ChatGPT for health information before clinical visits, yet the impact of an actual orthopedic consultation on patient trust in AI-derived information remains unknown. This prospective longitudinal observational study quantifies how a single orthopedic outpatient consultation modifies patient trust in AI chatbots, the concordance between AI-derived and physician-delivered information, and patient anxiety, using a paired pre-post survey design supplemented by a matched physician-side assessment. Adult patients (18 years and older) presenting to two orthopedic outpatient clinics in Cyprus complete a brief pre-consultation questionnaire (T0) capturing demographics, AI use patterns, prior AI consultation regarding the current complaint, baseline trust, expectations, and anxiety. Immediately after their consultation they complete a second questionnaire (T1) assessing concordance with physician advice, trust change, consultation facilitation, post-consultation anxiety, and future intention. The consulting physician completes a brief 30-second post-visit form capturing whether AI was discussed, the medical accuracy of AI-derived information conveyed by the patient, and the effect of the AI discussion on consultation duration. The primary outcomes are the paired within-patient change in AI trust between T0 and T1 and physician-patient concordance on AI versus physician advice. Target enrollment was 180 to obtain 150 paired completed assessments; 350 participants were enrolled.

A TEACH-BACK APPROACH TO INCREASE BREAST CANCER KNOWLEDGE IN WOMEN WITH LOW HEALTH LITERACY: AN INTERVENTION STUDY

Objective: This study aims to evaluate the effectiveness of the "Teach Back" technique in increasing breast cancer knowledge among women with limited health literacy. Method: This research is a randomized controlled experimental study. The study is planned to be conducted with individuals who applied to the KETEM unit of Healthy Life Center No. 1, affiliated with the Karabağlar District Health Directorate in İzmir. Data will be evaluated for normality; dependent samples t-test will be used for pre- and post-education comparisons, and Wilcoxon signed-rank test will be used if normality is not achieved. Baseline differences between the experimental and control groups will be analyzed with independent samples t-test or Mann-Whitney U test, and categorical variables will be analyzed with the Chi-square test. In the study, the experimental group will receive breast cancer education in groups of 5, consisting of 20-minute sessions with a 4-week interval, presented in simple language avoiding medical jargon, and the education content will be re-explained by the participants in their own words. These sessions will consist of general content such as breast cancer risk factors, symptoms, and the importance of early diagnosis. 1. What are the risk factors and symptoms of breast cancer? 2. The importance of early detection of breast cancer (BSE, clinical breast examination (CBE), mammography). 3. What are the treatment options for breast cancer? (Surgical methods, systemic treatments (endocrine therapy, chemotherapy, hormonal therapy), and radiotherapy) (Kiyat \& Akyüz, 2024; Uçkaç, 2022; Altu et al., 2023; Hosseinifar, Afkhamzadeh \& Moayeri, 2024). The control group will be educated using existing educational materials used by the Ministry of Health. The content of these trainings will consist of topics such as breast cancer risk factors, symptoms, and the importance of early diagnosis. The Teach Back technique will not be applied to the control group.

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.