Clinical Research Directory

Promoting Walking Among Older Adults Through Affective Communication and Step-Monitoring

Physical inactivity increases substantially after age 60 and represents a major public health challenge in older adults, as it is linked to increased risk of functional and cognitive decline and aging problems. Walking is one of the most accessible and recommended forms of light-to-moderate physical activity for this population. However, promoting sustained engagement in walking remains difficult, as traditional informational approaches often fail to activate personally meaningful motivations. This study tests whether persuasive affective messages can promote walking by leveraging self-continuity, meaning the use of autobiographical memory to maintain the sense of being the same person across time and contexts, connecting the past, present, and future self. Self-continuity is associated with psychological resources such as self-esteem, self-efficacy, and a sense of meaning in life. The affective mechanism that sustains self-continuity is nostalgia: both promote emotional and behavioral regulation and support goal achievement. Building on this framework, the present trial examines whether activating feelings of self-continuity and positive nostalgic memories can strengthen older adults' motivation to engage in walking behavior. In addition, the study investigates whether combining self-continuity messaging with a self-regulation strategy (daily step monitoring) enhances intervention effectiveness. Self-monitoring is a well-established behavioral technique that supports goal pursuit by increasing awareness and feedback. Using a 4-arm randomised controlled factorial design, the study compares the effects of self-continuity messages, step-monitoring reminders, their combination, and an active control condition on walking behaviour and its psychological determinants. A national sample of 1,000 Italian adults aged 65-74, recruited through a certified panel provider (Ipsos) and balanced for age, gender, and geographic region, will be randomly assigned to one of the four conditions. All participants will receive one message per day through a mobile application over a 14-day period. Participants in the step-monitoring conditions will also be asked to track and report their daily step count using a pedometer application. Behavioral, psychological, and process measures will be collected at baseline, post-intervention, and follow-up. The study therefore aims to provide experimental evidence on the role of self-continuity as a motivational driver of health behaviour change, and to clarify whether combining affective and self-regulatory strategies enhances intervention effectiveness in older adults.

Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.

Reminder Strategies to Improve Meal-Logging Adherence

This study is a single-center micro-randomized trial, aiming to examine the effects of two theory-driven reminder strategies on adherence to repeated, image-based meal logging in adults age 45 and older. Three times daily, participants are automatically randomized to receive one of three reminder messages prior to each habitual mealtime. The main research questions the trial aims to answer are: * Do loss-framed reminders (emphasizing loss of a daily financial reward for not logging) increase meal logging adherence in the two hours following a reminder, compared to a neutral reminder? * Do logging consistency reminders (providing feedback on recent logging streaks) increase meal logging adherence in the two hours following a reminder, compared to a neutral reminder? * Do the effects of loss-framed and logging consistency reminders differ from each other? Primary aim: To estimate the proximal effect of each reminder type on whether a participant logs a meal within two hours of receiving a reminder. Secondary aim: To examine whether within-person physiological patterns (e.g., heart rate variation) moderate response to reminders, with the goal of identifying physiological markers of receptivity to behavioral prompts. The trial aims to enroll 200 adults aged 45 and older. Participants attend a baseline visit for onboarding, consent, and device setup, followed by a 28 day remote intervention period during which they should photograph their meals three times daily (breakfast, lunch, dinner) and wear a smartwatch and smart ring continuously. Prior to each mealtime, they receive an automatically randomized reminder message. Participants earn a daily financial reward contingent on completing meal logging for that day. Note: This trial was registered retrospectively as enrollment began prior to registration. However, registration was completed before data collection was finished and before any data analysis was conducted.

Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY

The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes. The main questions it aims to answer are: 1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)? 2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)? 3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care? This study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care). Participants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.

Smartphone Use in Healthcare Settings Among Nurses

This study assessed patterns of smartphone use among nurses and evaluated its impact on clinical performance and patient safety in healthcare settings in Egypt, using a convergent mixed-methods design. A cross-sectional survey was conducted between October 2025 and February 2026 across diverse clinical settings at Alexandria University Hospitals, including critical and emergency care, medical-surgical wards, operating theaters, outpatient clinics, home care services, and psychiatric support units. Of 900 nurses invited, 368 completed the online questionnaire via Google Forms (response rate: 40.9%). Quantitative data assessed nurses' patterns of smartphone use and its impact on patient care using an adapted validated scale. Qualitative data were collected through two open-ended narrative questions exploring smartphone-related clinical incidents and recommendations for safe use. A total of 105 clinical incidents attributed to smartphone distraction were identified and categorized into four themes, while 176 respondents provided actionable recommendations categorized into five strategic pillars for safe clinical integration.

Use of a Comprehensive, Mobile Application to Assist Cancer Patients With Diet, Nutrition and Activity

The overarching purpose of this study is to assess whether patients will use the app throughout treatment on a regular basis, as the ultimate goal is to provide an educational platform that can impact patient behaviors and understanding towards health.

Effect of a Pender Model-Based Mobile App on Symptom Severity, Quality of Life, and Sleep in Menopausal Women With Urinary Incontinence

Objective: This randomized controlled trial aims to examine the effects of education and counseling delivered through a mobile application based on the Pender Health Promotion Model on symptom severity, quality of life, and sleep quality in menopausal women with urinary incontinence. Methods: The study was conducted at Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, targeting women who presented to the urology outpatient clinic and met the inclusion criteria. The sample consisted of 82 participants, with 41 women in the intervention group and 41 in the control group. To account for potential dropouts during the mobile intervention, the sample size was increased by 20% above the calculated requirement. Data collection tools included the Descriptive Information Form, Incontinence Quality of Life Questionnaire (I-QOL), Incontinence Severity Index (ISI), International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), and Pittsburgh Sleep Quality Index (PSQI). The intervention group received an 8-week mobile application-based education program developed in line with the Pender Health Promotion Model. Additionally, participants in the intervention group were contacted twice weekly by phone for counseling and support. The control group received no educational intervention but was assessed with pre-test and post-test measurements. Results: Data were analyzed using descriptive statistics, independent and paired sample t-tests, one-way and repeated measures ANOVA, Pearson correlation analysis, and chi-square tests for group homogeneity. The study aims to determine whether the mobile application-based intervention significantly improves urinary incontinence symptoms, quality of life, and sleep quality compared to the control group. Conclusion: This study may provide evidence supporting the use of mobile health interventions based on health promotion models like Pender's to enhance the management and overall well-being of menopausal women with urinary incontinence.

Smartphone vs Manual Interpretation of Biomarkers for Ovulation and Luteal Phase Detection (SMOM Study)

This study will compare different combinations of fertility signs (cervical mucus (CM), luteinizing hormone \[LH\], pregnanediol glucuronide \[PDG\], and basal body temperature \[BBT\]) to determine which are most reliable for identifying ovulation and luteal phase length. Thirty existing Premom App users will track daily observations for three menstrual cycles. Participants will record mucus, perform urine tests, upload test strip photos to the Premom App, and measure BBT. Both participant readings and AI-assisted app readings will be analyzed. The main goal is to find which marker pairings give the most accurate picture of ovulation timing and luteal phase length. Secondary goals include understanding ease of use, the number of tests required, and whether the app improves accuracy.

The Effect of Education on Quality of Life, Adherence to Immunosuppressive Therapy and Symptom Control in Organ Transplant Patients

Organ transplantation is the most effective method for treating end-stage organ failure and allows patients on the verge of death to continue living. Organ transplantation involves removing all or part of an organ or tissue from the body and transplanting it to suitable patients experiencing failure. Therefore, transplants are performed to treat diseases, save lives, improve patients' quality of life, and extend their life expectancy. The World Health Organization (WHO) defines quality of life as individuals' perceptions of their goals, expectations, standards, and concerns regarding their place in life, within the context of the culture and value systems they live in. Achieving an adequate quality of life after transplantation is considered an indicator of therapeutic success, which is increasingly important to measure by the transplant care team. Individuals who undergo transplantation and their families often perceive transplantation as a rebirth. However, 30% to 40% of patients report no better health-related quality of life after kidney transplantation compared to dialysis. This is attributed to frequent checkups and monitoring, new medications and their strict dosing schedules, and the unexpected discomfort of potential side effects. Even after the psychological challenges of waiting and the joy of a successful transplant, transplant recipients take on new responsibilities. Problems such as accepting transplantation risks, acute and chronic organ rejection, and adherence to lifelong medication regimens can arise. Persistent side effects of various immunosuppressive agents, adaptation and maintenance of the new organ, and uncertainty about the future due to rejection of transplanted organs and the subsequent re-transplantation process can all lead to physical and psychological distress. Immunosuppressive therapy represents a lifelong endeavor for transplant recipients. These medication regimens involve complex protocols, not only due to the number of pills required, but also due to blood level monitoring, side effects, and frequent dose adjustments to avoid rejection. Non-adherence to immunosuppressant regimens has been shown to be high in organ transplant patients. Non-adherence rates in this population are reported as high as 65%. The highest immunosuppressant non-adherence rate is found in kidney transplant recipients, with a prevalence of 36-55%, while this rate is 15-40% in liver transplant recipients. Studies have found that 16-36% of graft losses are associated with non-adherence. The ever-growing population of transplant recipients and the limited number of transplant centers, particularly those living farther away, necessitate innovative healthcare delivery models to monitor and improve the use of transplant center resources. With the advent of smartphones and mobile medical devices, mobile health has become a popular way for healthcare professionals to manage patient care. Mobile health can serve as an adjunct method for delivering health education information, sending reminders to patients to take their medications, and implementing online education. In particular, converting paper-based education to video format can significantly increase knowledge on various topics. It is necessary to address the problems and challenges patients face after discharge and the practices that can potentially address these issues. These results suggest that healthcare professionals can do more to provide comprehensive care to patients, promote successful home-based treatment regimens, symptom control, and quality of life.

Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience

The study focuses on patients who require outpatient infusion of therapy ("Infusions, Intravenous"\[Mesh\]) "Administration, Intravenous"\[Mesh\] ("Home Infusion Therapy"\[Mesh\]) "Parenteral Nutrition, Home"\[Mesh\] via a peripherally inserted central catheter (PICC) ("Central Venous Catheters"\[MeSH\] "Catheterization, Central Venous"\[MeSH\] "Catheterization, Peripheral" \[MeSH\] "Vascular Access Devices"\[Mesh\] )

Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation

This study is a single-center, prospective, randomized controlled trial targeting endometrial cancer (EC) patients undergoing fertility-sparing treatment at Peking University People's Hospital from March 2025 to March 2027. The aim is to evaluate the efficacy of an intelligent mobile application (APP) based on the Adaptive Behavioral Intervention (ABI) framework in weight management for obese or overweight endometrial cancer patients receiving fertility preservation therapy. Additionally, the study seeks to explore its potential advantages in improving body mass index (BMI), tumor regression, and glucose and lipid metabolism profiles.

The Effect of Peer Mentoring Model Supported by Mobile Application

This study investigates the effects of a peer-guided model supported by a mobile application on nursing students' educational processes. The primary goal of the research is to assess the potential impact of this model on students' self-efficacy, university adaptation, and academic success. The study will be conducted as a randomized controlled experimental design with 70 nursing students. The experimental group will have 35 students, while the control group will also include 35 students. The data collection tools will include a student diagnostic form, university adaptation scale, satisfaction with educational methods scale, academic self-efficacy scale, and academic achievement scale. The research process will include the application of the student diagnostic form, the development of the mobile application, an informational meeting about the peer-guided model for students, randomization, mentor-mentee assignments, initial data collection, and the stages of initiation, training, separation, and re-evaluation. The use of the peer guidance model and mobile application will be emphasized during the educational process. Motivating peer leaders and achieving the program's objectives will be ensured through peer leader seminars. Data analysis will be performed using SPSS 25.0 software, with an initial examination of the data distribution. T-tests or one-way ANOVA will be used for normally distributed variables, and the Scheffe test will be applied to identify differences. Mann-Whitney U and Kruskal-Wallis tests will be used for non-normally distributed variables. Additionally, Pearson correlation analysis will determine relationships between continuous variables. The effects of independent variables will be evaluated using multiple regression analysis (Backward method). Statistical significance will be assessed at a p-value of \<0.05. This study has been designed according to CONSORT standards, and all necessary ethical approvals and institutional permissions have been obtained.

Designing a Mixed-initiative Recipe Recommender App for Vegan and Vegetarian Sub-groups

The goal of this study is to test the usability and applicability of a mobile application which recommends recipes. We will recruit up to 52 vegan/vegetarian participants in Belgium, and provide them with an iDOO hydroponic plant growing unit (https://www.idooworld.com/products/idoo-20pods-indoor-herb-garden-kit-hydroponics-growing-system-with-led-grow-light) as well as seeds and plant nutrients to grow certain herbs at home. Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.

Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment

In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal preoperative assessments when the participants are evaluated through a web based application (Preanestes@s) versus the traditional outpatient interview.