Clinical Research Directory

Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI

This project aims to evaluate the usability, acceptability, and impact of the Oups! mobile app and a connected Bluetooth dynamometer for at-home PFM training to treat UI. The study will: 1. assess usability and participant feedback on the Oups! app, identifying improvements; 2. evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and 3. measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.

Modifying the Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department for Telehealth

The goal of this clinical trial is to determine the feasibility of eGAPcare, a telehealth modification of the GAPcare fall prevention intervention, in older adults in a community emergency department. The main questions it aims to answer are: * Can telehealth physical therapy and pharmacy consultations be conducted in a community emergency department? * Does the telehealth modification of GAPcare decrease recurrent falls at 6 months? Participants will * Receive telehealth physical therapy and pharmacy consultation while in the emergency department * Participate in follow-up visits over the phone for 6 months following the initial emergency department visit * Complete study questionnaires delivered by study staff.

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 Virtual Doula Services on Birth Outcomes in Rural Communities

This study will assess the impact of virtual doula care on birth and postnatal outcomes among rural mothers. The goal of virtual doula services is to improve access to care in underserved communities and decrease urban-rural differences in key maternal health outcomes including mode of birth (cesarean vs vaginal) and birth satisfaction. By implementing a digital randomized controlled trial, the study team will efficiently recruit a national sample of rural pregnant women to provide evidence of the effectiveness of virtual doula care, the appropriateness of virtual visits for different care and support needs, and the role of virtual care in improving maternal health.

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.

Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults

The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer: \- Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to face-to-face adjustments? Researchers will compare remote fine-tuning (using a smartphone app) to traditional face-to-face fine-tuning sessions in a clinical setting. Participants will: * Be randomized to either the remote fine-tuning group (intervention group) or the face-to-face adjustment group (control group). * Attend five scheduled consultations over a 3-month period, including baseline measurements, hearing aid fittings, and follow-up visits. Participants in the remote fine-tuning group will: \- Set up and use a hearing aid manufacturer's smartphone app to complete fine-tuning sessions from home. Participants in the face-to-face group will: \- Visit the clinic for in-person fine-tuning appointments. Data will be collected through questionnaires (e.g., SSQ-12, IOI-HA, and COSI) and objective measures such as the Speech Intelligibility Index (SII) and speech comprehension in noise (DS-FF). Additional qualitative data will be gathered from interviews with participants in the remote fine-tuning group.

Ostomy Rural Telehealth Training Cancer Survivors

Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates 43,030 rectal cancer cases and 81,190 bladder cancer cases will be diagnosed in 2018.Of these, at least 30,000 will receive ostomies, and an additional unknown number due to gynecologic, other gastrointestinal, or other gastro-urinary tumors. The health-related quality of life impact is tremendous and greater than with many other cancer treatments. An ostomy is often a prolonged or lifelong disabling problem for cancer survivors. The adaptation period is quite variable. In our R01 study, 18% of participants took at least one year to be comfortable, or never felt comfortable, in managing their ostomy care. Importantly, many patients cannot attend in-person self-management programs or patient groups for a myriad of reasons, including distance to travel, lack of access to transportation, monetary outlays, competing demands (such as work), or comorbidities making travel difficult. In addition, a national shortage of OCNs means patients with an ostomy, whether newly placed or a long-term issue, receive little help. It is imperative to study interventions for rural survivors aimed to limit family financial burdens, improve ostomy outcomes, and improve survivors' well-being.

Dance and Blood Flow Restriction as Balance Training for Older Women

Falls are one of the leading causes of hospitalization and mortality among older adults (aged 65+) in Canada. Falls result from postural instability following age-related declines in muscle strength which begin in the 5th decade of life. Older women have higher rates of injury from falls due to greater deterioration of bone mass density and lower levels of physical activity when compared to men. Participation in physical activity and exercise has been shown to slow these age-related declines in postural stability by improving muscle function as well as proprioceptive and sensory systems, however the majority of older women are inactive. Dance has been used to inspire physical activity uptake among older women, and is particularly good for balance due to its both sensory and motor aspects that focus on precise execution of movement. Dance interventions have been found to improve postural stability and balance confidence. Post-pandemic, online dance classes have provided greater accessibility to exercise interventions aimed at promoting balance. These help reach women facing transportation barriers, who have a fear of exercising with others, women with time-consuming caregiver roles at home etc. While beneficial, the intensity of online classes must be lower to ensure safety, thereby limiting physiological stimulus for adaptations. As typically higher intensity exercise is needed to promote muscle strength there may not be adequate stimulus for adaptations. Furthermore, there is little evidence of strength gains even from in-person dance classes. Blood flow restriction may offer an easy and cost-effective way to mimic higher intensity exercise and boost training benefits. Blood flow restriction has been found to boost strength during low-intensity resistance training, but there is little information on adaptations after balance training or potential transfer to reduce the risk of falls. This 12-week online exercise intervention investigates whether blood flow restriction during dance classes can augment strength, dynamic balance and postural stability of older women aged 65 years and above. Two groups of older women will participate in twice weekly 75 minute ballet and modern-dance classes over Zoom. One group will be randomized to wear 5 centimeter elasticised blood flow restriction bands on their proximal thighs during the classes. Bands will be tightened to a 7/10 of perceived tightness. Postural stability will be assessed using 9, 30-second trials of quiet standing on a force platform in conditions of eyes-open, eyes-closed and on a foam block - trials will be staggered to reduce fatigue effects. Trials will also be video recorded for kinematic analysis of shoulder and hip displacement using Kinovea. Dynamic balance will be assessed using the Star Excursion Balance Test. Participants will be asked to stand on one foot in the middle of the star and reach their other leg as far as they can above the line. The distance the participant reaches in each direction will be recorded and normalized by limb length. Strength will be assessed using the 30-second Sit-to-Stand test and Calf-Raise Senior test. Both tests involve participants doing the maximum number of repetitions possible within a 30-second time frame. Finally scales of fears of falling and overall perceptions of health will be collected. It is expected that this study will have great practical implications as the accessibility of this program can provide opportunities to older adults from various remote locations to increase their levels of physical activity in a safe manner. The affordability may also aid in adoption by community health and recreation centers as an easy-to-implement program that helps to reduce the risk of falls of older women, thereby promoting independence and quality of life.

Health Education for Women With Suspeced Infertility Waiting for Specialized Care

Introduction: Infertility is defined as a couple's inability to achieve pregnancy after 12 months or more of regular unprotected intercourse. In Brazil, it affects around eight million people. While health services provide resources for contraception, little attention is given to supporting conception and preserving fertility. Objective: To evaluate the effectiveness of a remote educational and counseling intervention on infertility. Method: Open-label randomized clinical trial. Couples referred for infertility will be identified in the electronic referral system. For inclusion, the woman of the couple must be 34 years old or less, no previous in-vitro fertilization attempts, and have access to telephone or internet. The control group will follow standard care, awaiting in-person consultation. The intervention group will also wait for in-person evaluation but receive additional education and counseling via video call. The primary outcome is the proportion of correct referrals according to local protocols. A total of 206 participants will be included to detect a difference between success rates of 50% and 30%, with 80% power and a 5% significance level.

Hypoglycemia Prevention and Awareness Program

The aim of this project is to examine the effects of the Hypoglycemia Prevention and Awareness Program (HypoPAP) on patient outcomes, including metabolic, psychological, social, and economic parameters, in individuals with type 2 diabetes and impaired hypoglycemia awareness. Through the interventions provided to participants, the study aims to achieve the following improvements: * Physiological parameters: Enhanced glycemic control, reduced hypoglycemia frequency, improved hypoglycemia awareness, and optimized HbA1c levels. * Psychological parameters: Reduced fear of hypoglycemia, increased hypoglycemic confidence, and improved attitudes toward hypoglycemia management. * Social parameters: Decreased social withdrawal due to fear of hypoglycemia, as assessed through relevant items in validated scales. * Economic parameters: Reduced frequency of hospitalizations and emergency department visits. Overall, the program seeks to enhance participants' ability to prevent and manage hypoglycemia, thereby improving their overall well-being.

Promoting Aging in Place Through A Wellness Program

Study explores the impact of an eight-week Healthy Aging Wellness (HAW) group-based program delivered online and in-person to improve hope and well-being in community-dwelling older adults.

Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up. This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.