Virtual Recruitment and Retention in a Multisite Clinical trial: Descriptive analysis of strategies used to engage Women Veterans with urinary incontinence
This descriptive analysis demonstrates that a pragmatic, virtual clinical trial successfully recruited and retained 286 women veterans with urinary incontinence by leveraging administrative data, flexible scheduling, and remote technologies to overcome specific barriers to care, though such strategies require additional staff time.
Original paper licensed under CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/). This is an AI-generated explanation of the paper below. It is not written or endorsed by the authors. For technical accuracy, refer to the original paper. Read full disclaimer
For many women, the simple act of laughing, coughing, or lifting a heavy object can trigger an embarrassing and disruptive leak of urine. This condition, known as urinary incontinence, is far more than a minor nuisance; it can lead to social isolation, depression, and a significant decline in quality of life. While the general population faces barriers to seeking treatment—such as the cost of care, a lack of awareness about options, or the shame of discussing a private medical issue—women who have served in the military face a unique set of challenges. Their service often involves carrying heavy equipment and enduring long periods without access to restrooms, factors that increase their risk for this condition. Furthermore, the very nature of military service can make women hesitant to visit clinics, and the logistical hurdles of traveling to medical appointments can feel insurmountable. For decades, researchers have wondered if moving these treatments online could solve these problems, but they lacked proof that women would actually sign up for, and stick with, a study conducted entirely through screens and phones.
A team of researchers at the Department of Veterans Affairs set out to answer this question by running a large, real-world experiment. They wanted to see if they could successfully recruit and keep women veterans in a study that offered two different types of virtual care for urinary incontinence. One group received daily lessons through a mobile phone application, while the other group had a single, one-hour video consultation with a specialist. The goal was not just to see if the treatments worked, but to figure out how to get women to join the study and stay involved without ever stepping foot inside a hospital. The researchers found that by removing the need for travel and using flexible, technology-based tools, they could indeed reach their targets, though the process required a significant amount of human effort and patience to guide participants through the digital landscape.
The study took place across three medical centers in the southeastern United States between 2020 and 2023. The team needed to find 286 women who were over 18, had experienced urinary leakage for at least three months, and had received care at a primary clinic recently. To find these women, the researchers did not rely on waiting for patients to walk in the door. Instead, they used three main strategies. First, they looked through electronic medical records to find women who had been diagnosed with the condition. Second, they asked doctors and nurses to recommend the study to eligible patients. Third, they placed flyers with photos of women veterans in clinic waiting rooms. Once they identified potential participants, the team sent them letters inviting them to join. If a woman expressed interest, a study coordinator called her to explain the study, answer questions, and check if she met the requirements.
Getting a woman to agree to join was only the first step. The researchers had to navigate a complex process to get her officially enrolled. In the early days of the study, this involved mailing paper forms for her to sign and return, a process that could take days or weeks. As technology improved, the team switched to using electronic signatures, which sped things up considerably. Once a woman was enrolled, she was randomly assigned to one of the two treatment groups. The mobile app group received daily activities for eight weeks to help them manage their symptoms, while the video group had one detailed conversation with an expert. Crucially, every step of this process happened over the phone or the internet. No one ever had to drive to a clinic, sit in a waiting room, or take time off work to participate.
The results showed that this remote approach worked. The team successfully enrolled 292 women and randomized 286 of them, hitting their goal within the planned timeframe. The vast majority of these women, about 79 percent, were found through the electronic medical records, proving that looking at data is a powerful way to find people who need help. The study also revealed that the women who stayed in the program were generally those between the ages of 45 and 64, a group that makes up the largest portion of the study's participants. While the researchers expected about a quarter of the women to drop out before the study ended, the actual number was slightly higher, with about 31 percent leaving the study early. However, the team noted that half of those who left did so before they even started the treatment, often because they lost interest or could not be reached by phone, rather than because the treatment itself was too difficult.
When the researchers looked at who stayed in the study, they found a small but interesting difference between the two groups. The women who had the one-time video consultation with a specialist were slightly more likely to complete the study assessments than those using the mobile app. This suggests that having a human connection, even just once, might help keep people engaged. However, both groups had strong retention rates overall, with more than two-thirds of the women completing the final assessments. The study also highlighted that the women in the trial were not a perfect mirror of all women veterans; there were more Black women and fewer younger women in the study than in the general veteran population. This reflects the demographics of the specific clinics where the study took place, but it also shows that the remote methods were effective at reaching the specific group of women who were most likely to participate.
The success of this project was not just about the technology; it was about how the human team used it. The researchers found that flexibility was key. They allowed women to schedule calls at times that worked for them, even if it meant late in the evening. They sent regular reminders and helped women troubleshoot technical problems, such as finding a registration email in a spam folder or learning how to log into a new app. The study team realized that while the internet removed the barrier of travel, it introduced new barriers of technology that required extra support. Without the staff spending extra time to guide participants through these digital hurdles, many women would have likely given up. The researchers concluded that while remote trials are a promising way to reach women who might otherwise be left out of medical research, they require a dedicated investment of staff time to be successful. The study proved that with the right mix of technology and human support, it is possible to bring medical research directly to the homes of women veterans, offering them a path to better health without the burden of travel.
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