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.

Feasibility and Efficacy of Ambulance-Based m-Health for Pediatric Emergencies (FEAMER) Trial

Investigators hypothesize that in a low-resource setting, linking ambulances that transport acutely ill children to a remote pediatric emergency physician using a simple audio-video device will improve the quality of these children's medical decisions and health outcomes. For this purpose, the investigators will conduct a study in Karachi, Pakistan, where they will collect medical data for ill children at the time of ambulance pickup, hospital drop-off, and during hospital triage. During transport, one group will receive a telemedicine call from a trained physician, while the other group will receive basic paramedic treatment. The investigators will then compare both groups.

App-based Breathing Program for Migraine Relief

Migraine is one of the most common neurological disorders, characterized by recurrent headaches, sensitivity to light and movement, nausea, and autonomic dysregulation. Although mind-body interventions like biofeedback have shown their efficacy, they remain underutilized due to barriers such as transportation, time constraints, lack of awareness, stigma, and cost. A targeted approach to enhancing HRV is HRV biofeedback (HRVB), a technique using visual or auditory feedback to help people regulate HRV through slow-paced breathing and positive emotional regulation to promote ANS balance and emotional resilience. Investigators will conduct a remotely delivered pilot RCT of an 8-week, 10 min/day, novel app-based HRVB intervention compared to a sham control intervention (matching intervention time and attention with no biofeedback component) in adult with chronic migraine. Investigators hypothesize data collected from the study will: a) support the feasibility and acceptability of the remotely delivered app-based HRVB intervention among adults with chronic migraine, and b) provide insights into refining the intervention by examining patterns of change in migraine and psychological outcomes from pre- to post-intervention.

mSaada: A Mobile Health Tool

In the R21 phase of this project, investigators will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness in assisting community health volunteer-led home-based HPV screening, and implementation factors. Investigators will carry out a six-month pilot of mSaada with community units in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a to determine effectiveness. In the R33 phase of the project, investigators plan to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. Investigators anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.

A Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment

Evira is a digital support system newly developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, enabling fast and easy communication with the clinic, parents and the clinicians can easily follow the child's weight development. The purpose of this randomized controlled study is to evaluate the effect of adding Evira to the already locally used life-style treatment of childhood obesity.

Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends and Family of Intimate Partner Violence Survivors

This research will support and empower friends/family (F/F) of intimate partner violence (IPV) survivors in Thailand, where IPV is critical and common, and survivors first and foremost seek help for abuse from their F/F. myPlan app (www.myPlanapp.org) is a free mobile evidence-based intervention app to prevent IPV. The app was first developed in the United States (US) and has been disseminated to high-income countries (e.g., New Zealand, Canada, Australia) and lowincome (Kenya). One new hope for improving survivors' psychological and well-being is adapting and introducing the myPlan app for the concerned friends/family who support survivors in Thailand. Therefore, the propose of this longitudinal research study, Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends/Family of Intimate Partner Violence Survivors in Thailand, will have two consecutive phases with three aims: 1) To tailor the myPlan app content for concerned F/F members of Thai IPV survivors, 2) To integrate the adapted myPlan app content for concerned F/F members of Thai IPV survivors, 3) To test the feasibility and acceptability of the adapted myPlan app with concerned F/F members of Thai IPV survivors. Phase 1 (Year 1-2) will achieve aim 1-2 to tailor the myPlan app with Thai survivors and friends/family. The investigators will review current content and conduct in-depth interviews with survivors and concerned F/F members on social norms associated with IPV, informal support systems and the role/responsibility in helping survivors, safety strategies used by concerned F/F members and negative consequences for both survivor and F/F member providing support. Moreover, in phase 1, the adapted content will be pilot tested with concerned F/F members of survivors by using cognitive techniques and theater-testing methodology. Phase 2 (Year 3-4) will achieve aim 3 to test the feasibility and acceptability of the adapted myPlan app with F/F. The investigators will conduct a two-group RCT design with concerned F/F member randomized to receive a) the myPlan app for F/F member, or b) standard usual-care safety planning information. Primary outcomes for F/F members include change in knowledge and attitudes towards IPV and F/F empowerment to plan and take safety support survivor. Secondary outcomes will examine change in F/F' distress, frustration and consequences for supporting the survivor. This phase will also collect feasibility and acceptability data to informed a planned R01 submission in Year 3 of the study. The K43 application outlines a four-year plan to support a candidate who is a nursing instructor with 15 years of work in diverse projects, settings, and disciplines; which positions her for a successful career as an independent researcher in research field of intimate partner violence. The career development plan provides a sequence of carefully selected training and mentoring experiences, including coursework to increase research capacity, leadership skills, mentored research leading to a R01 proposal, peer reviewed publications, and professional networking, that will catapult this research to the next level of research achievement. The team will be a collaboration between the Boromarajonani College of Nursing Khon Kaen (BCNKK), Khon Kaen One Stop Crisis Center (OSCC), Johns Hopkins University (JHU), Notre Dame of Maryland University (NDM), and Auckland University of Technology (AUT), New Zealand.

SpiroGym App-Aided Cough Rehabilitation

The pilot study by Srp et al. (2021) proved that the SpiroGym app was feasible for supporting expiratory muscle strength training (EMST) in Parkinson's disease (PD) patients. Two weeks of intensive EMST coupled with SpiroGym were sufficient to significantly improve the participants' voluntary peak cough flow (PCF). The improvement was quantitatively comparable to the results of other intensive EMST studies with longer durations. When interpreting such rapid improvement, the impact of SpiroGym's visual feedback was considered. It was assumed that visual feedback increased training effort compared to regular training without immediate control. However, comparative studies were required to verify the possible additional effects of visual feedback on voluntary PCF compared to EMST without feedback.