Clinical Research Directory

Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents

The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.

Mobile Application for Women With Polycystic Ovary Syndrome

Objective: The aim is to develop a mobile application based on the Health Promotion Model for the management of PCOS and to determine the effect of this application on improving nutrition and exercise behavior in women with PCOS. Method: The study population will consist of 114 women diagnosed with PCOS according to the Rotterdam criteria (2003) by a specialist in Obstetrics and Gynecology (G power 3.1.9.7). Inclusion criteria are being over 18 years old, female, diagnosed with PCOS, willingness to participate in the study, owning a smartphone with Android or iOS operating system, having digital literacy, and not having a diagnosed psychiatric condition. Exclusion criteria include being pregnant or planning to become pregnant during the study, having musculoskeletal, neurological, respiratory, or cardiovascular diseases, undergoing any surgery or having health issues that could affect physical activity for more than a month, unwillingness to participate in the study for any reason, and not having internet access. Participants will be randomly assigned to either the experimental or control group. The experimental group will receive a PCOS-specific exercise and nutrition program through the mobile app based on the Health Promotion Model, while the control group will receive the program via a pamphlet and it will be applied over 8 weeks. The mobile application will include an exercise program, nutrition counseling, and health coaching for PCOS management, all aligned with the Health Promotion Model. At the beginning and end of the study, participants' blood measurements, anthropometric measurements, physical activity levels, exercise behavior, and adherence to the Mediterranean Diet will be evaluated.

MOBILE EDUCATION AND COMFORT IN OSTOMY PATIENTS

Purpose of the Study This study aims to understand whether a mobile education program can improve comfort levels in people living with a stoma. A stoma is a surgical opening created on the abdomen to allow stool or urine to leave the body. Living with a stoma can affect daily life in many ways, including physical comfort, emotional well-being, social life, and the home environment. The education program used in this study is based on Kolcaba's Comfort Theory. This theory focuses on comfort as a whole and includes physical, emotional, social, and environmental aspects of a person's life. The study will compare people who receive mobile education with those who receive standard hospital care only. Who Can Take Part Adults aged 18 years and older who are scheduled to have colostomy, ileostomy, or urostomy surgery may take part in this study. Participants must be able to communicate in Turkish, read and understand written information, and agree to join the study voluntarily. People with severe cognitive problems, serious communication difficulties, or major vision or hearing problems will not be included. What Will Happen in the Study Participants will be randomly assigned to one of two groups: Mobile Education Group Standard Care Group Both groups will receive routine care provided by the hospital. Participants in the mobile education group will also receive access to a mobile application designed specifically for people with a stoma. This application includes: Easy-to-understand information about stoma care Animated educational videos showing step-by-step stoma care practices Guidance on skin care, pouch changing, and hygiene Information on common problems and when to seek medical help Reminders to support daily stoma care routines The mobile application can be used on smartphones and does not include diagnosis or treatment. It is for education and support only. Participants in the standard care group will receive usual hospital education and care. After the study is completed, they will also be offered the mobile education program. What Participants Will Be Asked to Do All participants will be asked to answer questionnaires that measure comfort levels at several time points: Before surgery One day after surgery Fifteen days after discharge (by phone) One month after surgery (during a clinic visit) Participants in the mobile education group will be shown how to use the application and may use it as often as they wish. Researchers may contact participants to ask about their experience using the app and to identify any difficulties. Possible Benefits Participants may gain better understanding of stoma care and feel more confident managing daily life with a stoma. The mobile education program may help reduce discomfort, support emotional well-being, and improve overall quality of life. The results of this study may help healthcare professionals develop better education tools and support programs for people living with a stoma. Risks and Safety This study does not involve experimental medical treatments. The mobile application provides education only. Personal data will not be collected through the app, and all information will be kept confidential. Participants may leave the study at any time without affecting their medical care. Why This Study Is Important Access to stoma care education can be limited due to time constraints, staff availability, and hospital resources. Mobile education may provide an easy and accessible way for people to receive reliable information whenever they need it. This study will help determine whether a comfort-focused mobile education program can support people living with a stoma and improve their overall comfort and well-being.

Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing

As many as 25% of pregnant women report mental health problems such as depressiveness and anxiety. This is a major concern as mental illness during pregnancy can have severe and long-lasting consequences for the pregnant woman, the baby, as well as the partner. Digital interventions (e.g., apps) have shown to be promising in promoting mental wellbeing, at scale, however, the majority of tools have been developed and evaluated in a general population rather than tailored for pregnancy. The objective of this trial is to investigate the effectiveness of a new digital tool (HealthyMoms4MentalHealth-app) on mental health outcomes during the perinatal period.

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

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

Mobile App-Based Infection Monitoring in Familial Mediterranean Fever

Familial Mediterranean Fever (FMF) is an autoinflammatory disease characterized by recurrent episodes of fever, abdominal pain, and serositis. FMF attacks often present with fever and systemic symptoms resembling infectious diseases, making it challenging in clinical practice to distinguish between an attack and an infection. Moreover, infections are known to trigger FMF attacks; however, the number of prospective studies evaluating this association remains limited. In the current literature, the frequency of attacks and triggering factors in FMF patients have mostly been assessed through retrospective chart reviews. Such methods are prone to incomplete or recall-based data regarding the onset of attacks and infection-related symptoms. With the growing availability of digital health applications, it has become possible to record disease symptoms in real time and on a regular basis, providing more reliable data for both clinicians and researchers. The present study aims to prospectively evaluate the relationship between infections and disease flares in FMF patients by systematically recording infection symptoms and attack characteristics through a mobile application. This approach is intended to achieve a better understanding of the infection-flare association, improve patient management, and prevent unnecessary treatments. In addition, the feasibility of mobile application-based patient monitoring will be assessed, and its potential contribution to routine clinical practice will be explored.

CesiKids Trial: Enhancing Psychological Resilience in Adolescents With Cancer

This study will develop and evaluate a mobile-based co-design intervention (CesiKids) to enhance psychosocial resilience in hospitalized adolescents aged 12-18 diagnosed with cancer. The program will be created using Bronfenbrenner's Ecological Systems Theory and designed in collaboration with nurses, recovered adolescents, and parents. A randomized controlled design will be used. The intervention group will participate in a four-week structured program, while the control group will receive standard care. Psychosocial resilience and coping outcomes will be assessed at baseline, post-intervention, and follow-up. This research aims to offer an evidence-based, scalable model to support resilience among adolescents with cancer in clinical settings.

Evaluation of the Effectiveness of a Mobile Application Developed for Hemodialysis Patients.

This study aims to evaluate the effectiveness of a mobile health application developed for adult patients undergoing hemodialysis treatment. The mobile application includes modules on adherence to medication, diet, and fluid restrictions, symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, and motivational content. It also features reminder notifications, an "Ask the Expert" module, and personal symptom tracking. The research will be conducted as a single-center, single-blind, randomized controlled experimental study. Participants will be assigned to intervention and control groups using block randomization. The intervention group will receive the mobile application, while the control group will receive standard care. Assessments will be carried out at baseline (T0), 1st month (T1), and 2nd month (T2). The measurement tools to be used include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, clinical parameters such as serum potassium, phosphorus, and albumin will be evaluated. A total of 72 patients (36 intervention, 36 control) will be included in the study. This study aims to assess the impact of a mobile health application on treatment adherence, symptom management, and clinical parameters among hemodialysis patients, and to develop a digital health model that can be integrated into nursing care.

Addressing Pregnant Women's First Trimester Worries and Information Needs With mHealth Solutions

The first 12 weeks of pregnancy, known as the first trimester, can be one of the most worrying times for women. (Where this lay summary refers to women, it should be taken to include people who do not identify as women but who have the capacity to become pregnant). Many experience nausea, bleeding, or anxiety about whether the pregnancy is progressing normally. Despite this, most women do not see a midwife or doctor until around 10 weeks into the pregnancy. This leaves a gap where they may have important questions but little professional support. As a result, many turn to mobile phone applications or the internet to find answers - but the quality of information online is mixed, and it can be confusing or even unsafe. This research aims to understand what support women really need in early pregnancy, what concerns they have, and whether a mobile health application (mHealth app) could help fill this gap in current pregnancy care in a safe and personalised way. The study will also ask healthcare professionals and digital health experts what such an application should include, and how it can be made accessible, and easy to understand for all women - including those with different levels of health knowledge and digital skills. To carry out the research, we will use a combination of online surveys and interviews. Women who are currently pregnant or have had a baby in the last two years will be invited to take part, along with healthcare professionals such as midwives and doctors, and experts in digital health. The survey will ask about their experiences in early pregnancy, how they have used digital tools or apps, and whether they felt their questions were answered before their first NHS appointment. The interview stage will allow participants to talk in more depth about what support they wanted and what would have helped them most. All participants will receive information about support services because we realise that discussing unmet information needs or worries in early pregnancy may be upsetting for some women. The views collected will inform the design of a new mobile application to support women during early pregnancy. The application will use artificial intelligence (AI) to personalise information based on each woman's needs and background, and to explain things clearly and simply. The content and design of the application will be reviewed by doctors and digital health specialists to make sure it is safe, accurate, and easy to use. Public and patient involvement is central to this project. A diverse group of women and representatives from grassroots organisations will be invited to shape the questions we ask, review the design of the application, and help us make it inclusive for people from different backgrounds. This research will help us create a practical, trustworthy, and inclusive tool to support women during one of the most vulnerable times in pregnancy when women don't usually see a doctor. If successful, it could be used widely across the NHS to help reduce anxiety, improve understanding, and ensure women get the right support earlier in their pregnancy with the long-term aim of improving outcomes for women, babies, and families across the UK.

Effect of a Mobile-Based Hydration Tracking Program on Knowledge, Attitudes, and Behaviors in Older Adults

This randomized controlled trial aims to evaluate the impact of a mobile-friendly, web-based hydration tracking application (named "SIVI") on hydration-related knowledge, attitudes, and behaviors in older adults. Inadequate fluid intake is a common and modifiable risk factor for dehydration in the elderly, leading to increased morbidity, hospitalizations, and functional decline. However, many older individuals forget to drink fluids or face barriers such as fear of incontinence, mobility limitations, or cognitive challenges. This study will include 70 community-dwelling older adults aged 65-84 years, recruited from a Family Health Center. Participants will be randomly assigned to either the intervention or control group. The intervention group will use the SIVI application for two months. The app is specially designed for older adults and includes features such as personalized fluid goals, reminders, hydration education modules, feedback, and a user-friendly interface with large fonts and high contrast. Participants will log their daily fluid intake, receive motivational messages, and access videos and information about healthy hydration habits. A water bottle will be provided to standardize measurement across groups. The control group will receive only routine care. Both groups will complete questionnaires measuring demographics, hydration knowledge, attitudes, behaviors, and fluid consumption habits at baseline, one month, and two months. Data collection will be conducted face-to-face by the researcher, and analysis will be performed using SPSS 22.0. Statistical tests will include descriptive statistics, Shapiro-Wilk for normality, chi-square for categorical data, and t-tests and ANOVA for comparisons over time. The results are expected to show that the SIVI application improves older adults' hydration knowledge, fosters positive attitudes, and promotes healthy fluid intake behaviors, thus supporting self-management of hydration and potentially reducing dehydration-related health risks.

Nurse Parental Support Using a Proactive Mobile App in Symptom Management for Children With Mechanical Ventilation

The aims of this study are to test the effectiveness of a nurse support using a proactive mobile app to enhance parental self-efficacy in symptom management for children using mechanical ventilations, and alongside identify factors facilitating or deterring the program implementation. A single group pre-post quasi-experimental study on parents of CMC requiring mechanical ventilation. Parents will be recruited from a non-government office, with an estimated sample size of 52 parents. Self-administrated questionnaire, and semi-structured interview guide will be used for data collection.

Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms

Forty percent of people living worldwide with Parkinson's disease (PD) are women. Twenty percent of patients have PD onset under the age of 60 years, a time when women may encounter significant caregiving responsibilities along with occupational and other competing demands. Studies with surveys of women with PD (WwPD) have reported worsening of PDrelated symptoms especially in the week prior and the week of menses. However, prospective evidence is scarce and clinical guidelines to manage this issue do not exist. As a result, care is either non-existent or fragmented. The investigators propose a French multicentre prospective pilot study to capture changes in PD symptoms in relation to the stages of the menstrual cycle aiming at reducing hormonal related worsening in PD symptoms through neurologist intervention and/or patient selfmanagement. Digital technology will remotely enable patient reported outcome (PRO) tracking through the My Moves Matter app changes in PD symptoms during several months. This information will then help neurologists to customize treatment. Changes in motor symptoms will also be highlighted by tracking through the use of a wearable device (PDMonitor) to objectively detect motor changes together with the app. This will further support the reliability of the app. This study will provide evidence for the impact of the menstrual cycle on PD and help neurologists and patients to better manage PD symptoms related to these hormonal changes.

Effectiveness Evaluation of a Mobile Application for Rheumatoid Arthritis

The aim of this experimental study is to develop a mobile application for patients with rheumatoid arthritis based on evidence-based recommendations and to evaluate the effectiveness of the developed application. Research Questions 1. Is the mobile application developed for patients with rheumatoid arthritis effective in improving their quality of life? 2. Is the mobile application developed for patients with rheumatoid arthritis effective in reducing their disease activity? The researchers will enable the intervention group to use the mobile application in order to assess its effectiveness, while the control group will receive routine care throughout the study period. Participants in the intervention group will use the mobile application for 12 weeks. Changes in the parameters determined by the researchers will be examined before and after the usage period. Patients in the control group will be evaluated after the initial consultation and at the end of 12 weeks. At the conclusion of the study, the control group will also be provided access to the mobile application.

A Digital Health Intervention to Promote Self-management in Patients With Chronic Obstructive Pulmonary Disease

Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. This patient group requires lifelong treatment in healthcare. A mobile application was developed to facilitate adherence to evidence-based guidelines for tailored breathing and airway clearance techniques to enhance self-management. The app is only in Norwegian and has a Norwegian name which is "Pust Deg Bedre" (PDB). The PDB app is fully developed and tested and can be downloaded for free. The app seems promising as a treatment tool, but has not yet been clinical evaluated. This project aims to 1) explore the feasibility of providing the app for patients with COPD, 2) explore the patients' with COPD experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 3) explore the physiotherapists' experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 4) explore the physiotherapists' experiences with implementing the PDB-app in treatment of patients with COPD, 5) explore the patients' experiences with the education in use of the PDB-app, and 6) At a 6-month follow up: explore the physiotherapists experiences with the usefulness and applicability of PBD-app, and to generally explore their experiences with participating in the project.

eHealth in Treatment of Gestational Diabetes (eMOMGDM)

The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way. In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.

Social Needs App for Oncology Patients Phase II

SNAP ON II is a two-arm, parallel-group, multi-center, randomized trial for patients diagnosed with cancer who are planning to undergo expected uncomplicated surgical intervention for their cancer. The study seeks to test whether a mobile app (developed by PistevoDecision) that identifies and connects patients to resources to meet their basic needs (e.g., housing, food, transportation, etc) ccan improve patient outcomes. Prior to their scheduled surgery, patients will download a mobile/web app that asks about their social needs. Then, the treatment group will be connected to community-based resources through FindHelp and the control group will receive access to the Centers for Disease Control tool called Lets Talk: Sharing Info About Your Family Cancer Risk.

Development of a Mobile Application and Determination of Its Effects

It has been determined that patients who have undergone heart surgery have a lack of knowledge about preoperative preparation and postoperative intensive care unit. In order to eliminate the lack of knowledge, patient education has gained importance in the preoperative period. At the same time, it is stated that nurses working in cardiovascular surgery intensive care units need continuous education to cope with the difficulties related to the increasing complexity of patient conditions and technology. With the advancement of technology, mobile applications have become an integral part of the continuous education of patients and nurses. This project was planned to evaluate the effect of the mobile application to be developed for patients who will undergo heart surgery on patient outcomes and the effect of the mobile application to be developed for nurses who provide patient care in intensive care units on the self-efficacy of nurses. In the first step of the project, the content of the mobile application will be developed, expert opinions will be obtained and the comprehensibility of patients and nurses will be tested. The software of the mobile application will be completed by shooting the necessary videos for the final content. In the second step of the project, the effect of the developed mobile application on anxiety, comfort and intensive care unit experiences in patients who meet the inclusion criteria will be examined. A randomized controlled experimental design will be used in this stage. State-Trait Anxiety Inventory, Early Postoperative Comfort Scale (EPQI), Intensive Care Experiences Scale will be used to collect data. Self-Efficacy Scale will be applied to nurses without randomization before and after using the mobile application. Data obtained in the study will be evaluated in a computer environment using SPSS data package program. In statistical decisions, p\<0.05 level will be accepted as a significant difference indicator.

The Effect of an Anti-Smoking Mobile Application on Self-Efficacy, Decision Making and Breath Carbon Monoxide Levels

Purpose:This research aims to examine the effect of a mobile application developed against smoking behavior on teachers' self-efficacy, decision-making and carbon monoxide levels in breath.The research was planned as a randomized controlled experimental type.Working in public schools in Izmir/Narlıdere District teachers constitute the universe of the research. According to the calculations made, it was decided to include 35 people in the experimental group and 35 people in the control group. After obtaining institutional permissions, teachers who meet the inclusion criteria will be determined.To ensure homogeneity, control and intervention groups will be stratified according to age, gender, and addiction levels.Assignment to intervention and control groups will be made by simple randomization method.The average scores of teachers' self-efficacy, breath carbon monoxide and decision-making levels are the dependent variables of the study.The status of using the mobile application is the independent variable. "Personal Information Form", "Fagerstrom Nicotine Dependency Test (FNBT)", "Self-Efficacy Scale", "Classification of Stages of Change Scale", "Decision Making Scale" and "Carbon Monoxide Measurement Values Tracking Form" will be used in this research. SPSS 26.0 Package program will be used to analyze the data in the study. It will be evaluated statistically at a 95% confidence interval and a significance level of p\<0.05. Number and percentage distributions for sociodemographic characteristics will be used in the analysis of the data.In comparisons between groups, parametric or nonparametric tests will be used after evaluating the normal distribution feature of the scale scores. Hypotheses 1 H1:There is a difference between the breath CO level scores of intervention and control group teachers according to time (pre-test - 1st month, 3rd month and 6th month). Hypotheses 2 H1:There is a difference between the self-efficacy scale scores of intervention and control group teachers according to time (pre-test, 1st month, 3rd month, 6th month). Hypotheses 3 H1: There is a difference between the decision-making level scores of teachers in the intervention and control groups according to time (pretest-1st month, 3rd month and 6th month).

Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy

To examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (DIBH), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care.