HydroAssist®

Hydrocephalus Association

Imagine having a headache and two hours later finding yourself in a surgical suite prepped for brain surgery. This is the life of uncertainty and unpredictability faced by individuals living with hydrocephalus. Hydrocephalus is a chronic neurological condition that has no cure and for which the only treatment requires brain surgery. Surgical intervention is often unplanned, as the primary device used to drain fluid from the brain - the shunt - has the highest failure rate of any medical device on the market and can fail at any time without warning. 40% of shunts will fail in the first 2 years of implantation and 80% will fail within 10 years. An alternative neurosurgical treatment eliminating the use of a shunt - an endoscopic third ventriculostomy (ETV) - can close, trapping fluid in the brain. The condition can be fatal if not attended to quickly. There are approximately 200,000 children and adults in the U.S. living with pediatric-onset hydrocephalus. Access to close and competent neurosurgical care is imperative for protecting the brain from irreversible damage and survival.

Patients and parents need a way to track symptoms over time and share those with their doctor so that they can identify a problem early and so that a family can plan for medical intervention and/or hospital admission. Apart from pen and paper, this does not exist. Furthermore, patients need to communicate the details of their current treatment to advocate for proper care with emergency personnel who often do not know about hydrocephalus and the urgency of intervention. Incredibly, the make, model, and setting of one’s shunt valve is typically not known by the patient or loved one because it is either not communicated at the time of implantation or the information is lost. Further, medical records and MRI/CT scans are not readily available, particularly if a patient is being seen at another medical facility. For hydrocephalus patients in countries not allowing patient access to electronic medical records, communicating their treatment and medical history rests solely on the individual and family who are typically under emotional duress and may not have the tools to store or communicate the information. In some cases, the symptoms being experienced by a patient - headache, vertigo, vomiting, dementia-like behavior - can rob a patient of the ability to verbally communicate at all.

HydroAssist® is a free mobile app built for both iOS and Android platforms intentionally designed as both an educational and a patient empowerment tool. The app allows patients to record and store their entire hydrocephalus treatment history, imaging (MRIs, CTs, X-rays), and medical documents. The app stores every U.S. FDA-approved medical device used to treat hydrocephalus including shunts, flushing devices, and casings. Patients can also store detailed information about their diagnosis, current medications, and other information they choose, as well as medical and emergency contact information. Treatment reports can be generated and shared via email. Patients can also track their symptoms over time and send them to their treating physician via text or email.

Hydrocephalus patients build support systems around themselves and need loved ones to be able to assist in the management of their condition. The app puts the patient at the center. Primary users can invite authorized users to assist in managing patient profiles by assigning various levels of permissions for each module within the app. Permissions include none, view, add, edit, and delete rights. Now, a mother, for example, can invite a father to co-manage their child’s information, allowing for real-time updates and access to the information. Medical team contact information as well as emergency contacts are stored in the app. Users also have access to educational resources about their condition and a physician’s directory to find a nearby doctor wherever they may be.

One in 770 babies (4,750) will develop hydrocephalus each year from various causes including genetic, fetal anomalies (eg. spina bifida, Dandy Walker syndrome, Chiari malformation), brain bleeds, stroke, brain tumor, brain infection, or traumatic brain injury. Many have comorbid conditions including epilepsy, cerebral palsy, autism, intellectual disabilities, physical disabilities, developmental delays, ADHD, learning disabilities, and memory challenges. Because of the high failure rate of the shunt, it is not uncommon for children to have more brain surgeries than birthdays during their elementary school years. This life of uncertainty and hypervigilance subjects both patients and families to incredible mental duress. A recent study found that 52% of parents ascribe their symptoms of post-traumatic stress syndrome with their child’s hydrocephalus. Every aspect of life is impacted (ie: sports, vacations), so as not to venture too far from their neurosurgical team or a center that can manage an emergency.

Pediatric neurosurgeons, pediatricians, and other specialized doctors feel the burden of the condition as they try to support the patient’s ongoing medical, social, and educational needs. And there is a care cliff for approximately 24K teenagers transitioning from the pediatric to adult health care systems. Adult neurosurgeons do not want to take on hydrocephalus patients, who require routine care. Many pediatric patients have extensive medical records and a complicated medical history which can include intellectual and/or physical disabilities. Neurosurgeons are accustomed to “fixing” a problem that allows an individual to return to their life or to be under the primary care of another medical professional, versus providing ongoing care. They have little financial incentive to take on care, as the payment for shunt revisions and office visits is low. Transitioning young adults and adult patients find themselves faced with nowhere to go to receive care, increasing the burden of managing their condition.

The paucity in care is particularly dire for individuals living in rural areas in the U.S. or in countries with a low neurosurgeon headcount. It is not uncommon for families in the U.S. to drive over 2 hours for a routine visit with their neurosurgeon or neurologist. In sub-Saharan African countries, it can be a two-day walk to a community health clinic where a family can then be transported to a hospital.

HydroAssist® provides patients with access to their information as needed, on their mobile device. It allows them to track symptoms, helping them see patterns emerging that could indicate a problem with their current treatment. This facilitates meaningful doctor-patient dialogue, allowing patients to engage in shared decision-making around their condition and plan for necessary interventions. It is particularly important for families caring for patients with intellectual or cognitive disabilities. It educates patients on what is in their bodies so that they can be their own advocates, particularly in supporting young adults’ journey from the pediatric to adult healthcare setting. Addressing these needs has far-reaching benefits on the mental well-being of both patients and family members. Patients report feeling like they have the freedom to move independently through their lives and the world.

HydroAssist® version 6 is available for free in both the App Store and Google Play. The app is coded to adhere to GDPR data privacy standards. The data is housed in the AWS environment, with quarterly security audits. There are currently 5,900 active users of the app, with the top users located in the United States, United Kingdom, Canada, and Australia.

Launched in 2016, the app has evolved from a simple means for patients to record their current treatment and store it on their mobile device to a multi-module cloud-based app. The latest version contains patient-requested features including the ability to manage multiple patient profiles (eg. families with multiple children with hydrocephalus), the ability to store medical documents and neuroimages, and the ability to track symptoms over time. Multiple individuals can assist in managing a patient’s medical information through permission-based access. Each version of the app is tested by a focus group of patients, caregivers, and medical providers. Coding has started, but is currently on hold, for the process of transferring patient profile ownership, facilitating young adults owning their medical information.

The main means for patients to record their current treatment was a paper card, similar to a business card, where they could write down the make, model, and setting of their shunt valve. This could be shown to emergency medical providers, radiologists, and other doctors, as needed. Many patients never received the card. For those that did, cards were lost, damaged, or worn over time. The advent of mobile apps allowed for the digitization of this card, which led to the first version of HydroAssist®. Imaging has continued to lag behind so, while many patients in the U.S. can access their medical record and even neuroimages through apps such as MyChart, these systems cannot be accessed across medical institutions by doctors. Other countries, like the UK, do not have user portals to access medical records. When patients request their MRIs or catscans, they are given their images on CD (not a thumb drive) to take with them if they are traveling. These barriers still challenge both doctors and patients. Doctors needed quick access to three key brain images to aid in the evaluation of a visiting patient, which led to the addition of the Image Library in the app. With the primary hydrocephalus medical information and history in the app, it was a natural evolution to include the ability for patients to track their symptoms and share those with their doctor.

The simplicty of uniting and digitizing has improved the lives of patients, encouraged doctor-patient communication and shared decision-making, and assisted in smoothing the journey for a young adult to the adult medical care system. We are just starting to see these benefits and the long-term impact they can have on patients and within the medical system.

However, the broader impact of the app is in the potential to support research and development that could lead to new interventions, treatments, and programs for patients and families. The data stored in HydroAssist® is data that has never been collected from patients living with hydrocephalus. It is a rich tapestry of the patient's lived experience side by side with treatment type and effectiveness. Researchers and industry have expressed interest in accessing the data as is. We see the HydroAssist® data as one part of a larger robust data repository that can bring together our patient-reported registry data and clinical data from our research networks to create a holistic view of the patient experience. This data set does not currently exist. There is no mandated reporting of hydrocephalus by the CDC.

HydroAssist® faces a financial challenge that is creating a barrier to growth and potential future self-sustaining revenue channels. The Hydrocephalus Association (HA) is a small non-profit with a $4 million annual operating budget. A gift from a private donor for the app has been exhausted. A small portion of the Amgen prize would allow us to complete the final feature set for the current version of the app as well as launch a marketing campaign to our user base. The association has a limited marketing budget and has been waiting to aggressively market the app until the release of this current version which incorporates the majority of user-requested features. Most marketing over the last 6 years has been driven by doctors asking their patients to begin using the app to assist in managing their care. The provider referrals indicate that doctors acknowledge and approve of its usefulness. 

The majority of the prize would focus on creating the interface that would facilitate querying the dataset for various stakeholders. We chose AWS as our data repository so that we could leverage their data visualization tools, machine learning, and AI to return meaningful de-identified, aggregated query results. The costs for this work would include the developer fees as well as legal fees for consultations to ensure that we are meeting all data privacy and security requirements to protect our patient data. Additionally, as the data will be used for research, we will engage a reputable third-party Institutional Review Board (IRB) to oversee the use of the data. Finally, the app will need to be coded to accommodate and track patient consent to opt-in to participate in any use of their de-identified data.

The HydroAssist® design team is comprised of a pediatric neurosurgeon, an adult neurologist, and the mother of a 23 year-old living with hydrocephalus who is also the COO of the Hydrocephalus Association. Dr. Jesse Skoch of Cincinnati Children’s Hospital is both a research scientist and a dedicated neurosurgeon. 40% of his patients are children living with hydrocephalus. Dr. Abhay Moghekar runs the Hydrocephalus and Cerebral Fluid Center at Johns Hopkins Medicine, is a research scientist with the Adult Hydrocephalus Clinical Research Network, and an advocate for hydrocephalus among his neurology colleagues. Amanda Garzon lives the hydrocephalus journey with her daughter who has undergone 17 brain surgeries to manage her hydrocephalus. Her daughter lives with epilepsy, executive function challenges, ADHD, memory impairments, and anxiety. Amanda oversees support, education, and advocacy programs at HA, leads video series, webinars, and educational sessions on various medical and lifestyle topics related to the hydrocephalus journey, and runs a support group in the Washington, DC area. While these three individuals bring their personal and professional experiences into the design of the app, they also understand that each patient and family’s journey with the condition is unique. Therefore, a focus group was formed pulling from a diverse group of individuals across age, etiology, treatment type, cognitive ability, race, educational attainment, socioeconomic strata, and geographic location. This group tests each version of the app prior to launch and provides suggestions and feedback on the roadmap of the app, assisting in prioritizing features and functionality. HA is able to unite a diverse and robust focus group because of its active engagement within the community through its various support groups, support hotline, and community events.

In the short term, we have two goals in addition to growing our user base:

Empower patients with information to be their own best advocates. We will accomplish this by listening to patient feedback through comments, surveys, and focus groups. We will measure this by the number of users that are actively using the app (new users, uninstalls of the app, and length of time between opening the app).

Increase the number of doctors adopting the app in their clinics. Hydrocephalus patients have a unique relationship with their neurosurgeons and other specialists. There is a doctor-focused awareness campaign led by Dr. Skoch to facilitate doctor adoption of the app. We will measure this goal by requests for marketing cards to HA, and the doctors' names captured in the database.

Over the next five years, we will work to:

Support the successful transition from pediatric to adult health care systems. Doctors have told us that HydroAssist® is a powerful tool to educate their patients and families on their treatment and to prepare teenagers for taking ownership of their medical care. Patients have told us that it helps them learn to talk to their doctors about the symptoms they are experiencing and opens up dialogue about their condition. In conjunction with a program HA is undertaking to work closely with pediatric neuro-focused advanced practice providers on transitioning patients to adult care, we will incorporate HydroAssist® and the “Transfer Ownership” trigger as a KPI. 

Provide new insights into the hydrocephalus patient experience. The goal is to open HydroAssist® up to be used as a research tool by both research scientists and industry partners. Measurement will be based on the successful development of the portal as well as the number of queries requested. We will also be working to unite HydroAssist with other key data sets to expand the insights into the patient population and the value of the data. 

We believe that HydroAssist® will have a positive impact on the mental health of patients and caregivers. We gather informal feedback on this through comments on digital media, feedback emailed directly to theHydroAssist® team, and in focus groups. We plan to survey users of the app to determine their attitudes and feelings related to managing hydrocephalus before and after using the app. We will probe for secondary and tertiary benefits through open-ended questions to bring forth those that are not readily apparent to the HydroAssist® team. We hope to see that patient and doctor communication is improved, particularly on the adult healthcare side. Dr. Skoch has discussed conducting a formal Quality Improvement study with the intent to publish in a reputable medical journal. 

HydroAssist® can be a valuable tool in the transition process. HA is working with the American Academy of Pediatric Neurosurgeons (AANS) Pediatrics Section to help inform the process of a successful transition to employ in clinics. HydroAssist® will be put forward as a tool patients should download and use. While this won't solve the challenge of adult providers not wanting to take on their care, it could make their care easier by having an informed and empowered patient, thereby lessening the perceived burden of this patient population. 

Doctors and neuropsychologists struggle to develop phenotypes of hydrocephalus to inform care and support for this patient population. Researchers want to focus their studies on interventions and treatments that alleviate the largest medical and social burdens of these patients. This is no recorded natural history of this patient population and the various subtypes of the disease. Additionally, there is no data that can connect symptomology with treatment effectiveness. HA is poised to be the leader in providing these insights with the various datasets they own, including HydroAssist®. We may finally be able to understand this patient population to serve them and their families better.

One full-time staff member, two volunteer medical consultants, one Amazon Web Servies contractor, one project manager and two developers through a contracted app development company.

9 years

The Hydrocephalus Association is committed to delivering programs and resources that are accessible to and serve the diverse community of individuals and families living with hydrocephalus, inclusive of race, ethnicity, ability, education, location, and socioeconomic status. Hydrocephalus does not discriminate and neither do we. With a small staff, one way we can reflect the makeup and meet the needs of our community is through the creation of focus groups and task forces to advise on the development of our educational programs and resources

HA’s Diversity, Equity, and Inclusion Statement

At the Hydrocephalus Association, we are committed to fostering an inclusive and equitable environment where all individuals, regardless of their backgrounds, experiences, or identities, feel valued, respected, and empowered. We believe that embracing diversity in all its forms strengthens our organization, enriches our perspectives, and drives innovation to better serve our community.

DIVERSITY

We recognize that diversity encompasses a wide range of characteristics, including but not limited to race, ethnicity, age, gender, sexual orientation, disability, socioeconomic status, religion, and cultural background. We embrace and celebrate this diversity as it contributes to the richness and strength of our organization and the hydrocephalus community as a whole. 

EQUITY

We are dedicated to promoting equity by ensuring fair treatment, equal access to resources, and opportunities for growth and development. We strive to dismantle systemic barriers and address disparities that may exist within our organization and the broader hydrocephalus community. By advocating for equity, we aim to create an environment where everyone has an equal chance to thrive and succeed.

INCLUSION

We are committed to fostering a culture of inclusion where all individuals feel welcomed, heard, and valued. We actively seek diverse perspectives, encourage open dialogue, and promote collaboration to create a safe and supportive space for everyone. By embracing inclusion, we aim to foster a sense of belonging, encourage authenticity, and empower individuals to contribute their unique talents and experiences to the betterment of our organization and the hydrocephalus community.

ACTION

We recognize that achieving true diversity, equity, and inclusion requires continuous effort and ongoing education. We are dedicated to implementing policies, practices, and programs that promote diversity, foster equity, and cultivate inclusion at all levels of our organization. We commit to regularly assessing our progress, listening to feedback from our community, and evolving our approach to ensure that we are continuously improving and creating a more inclusive and equitable environment.

Together, as a united community, we will work toward a future where everyone impacted by hydrocephalus can thrive, regardless of their background or circumstances. By embracing diversity, promoting equity, and fostering inclusion, we will drive positive change, advance research and treatment, and empower individuals to live their fullest lives.

The Hydrocephalus Association (HA) was founded in 1983 by parents of children with hydrocephalus. At a time when there was little to no information about the condition, we provided support services and educational resources to individuals and their families. Today we have grown into a national organization and have expanded to include four program areas: support, education, research, and advocacy.

Support and Education Our team includes staff and volunteers with extensive knowledge and personal experiences with the condition. We provide invaluable assistance and guidance for both people who are newly diagnosed and those who have been living with hydrocephalus through one-on-one support, online and in person support groups, and our pen pal program. We produce numerous free publications and our mobile app, HydroAssist. We host webinars, education days, and conferences with leading experts, providing individuals with current, relevant information about research, medical technologies, and educational resources. We have a dedicated Medical Advisory Board of clinicians and scientists who advise on the creation of our publications and programs. We are fully committed to providing accurate and trusted information and supporting patients and families every step of the way. Through our resources, events, and support services, we aim to connect individuals with a strong, supportive community of peers who understand their experiences. HA is there as our community navigates and manages their condition.

Advocacy Our Hydrocephalus Action Network (HAN) empowers our community to assure that the federal government is investing adequate funds to support hydrocephalus research for improved treatments and cures as well as appropriate programs that support those affected with hydrocephalus, particularly around healthcare, education, and labor issues. 

Research Our Research Program funds innovative, high-impact research to prevent, treat, and ultimately cure hydrocephalus. We are the largest private funder of hydrocephalus research in the country and sustain two clinical research networks, the pediatric-focused Hydrocephalus Clinical Research Network (HCRN) and the Adult HCRN (AHCRN), as well as a basic science network, the HA Network for Discovery Science (HANDS). Through collaboration with industry, scientists, and clinicians, we advance treatments, support new devices and drugs coming to market, enhance clinical care, and bridge the gap between basic and clinical science. Since starting our Research Program in 2009, there is now a 36% decrease in shunt infection rates and over 11 drug therapies are in various stages of testing. Over those 15 years, HA has invested $14 million into research and our return on investment has been $74 million, as our funded scientists and clinical networks have gone on to secure even greater funding amounts through the National Institutes of Health (NIH), the Department of Defense (DOD), and other foundations. Our research is driving change and creating a better future for individuals with hydrocephalus.

Our commitment is to provide HydroAssist free of charge to our patient community, particularly those most vulnerable and underserved by the medical system, including individuals with limited income, disability, and/or living far from their medical institution.

To this point, HydroAssist® has been funded primarily through budgeted programmatic funds and, more recently, a 2023 donation of $70,000 from a private donor and two small grants from other non-profit partners. Harry’s HAT in the United Kingdom provided a $5,900 grant. Hope for Hydro awarded Dr. Skoch and HydroAssist® the 2022 Hope Award with a grant of $5,000. We take advantage of nonprofit programs through TechSoup and Amazon, providing a $1,000 credit to offset AWS expenses. Current annual expenses vary depending on whether we are in a programming push to launch new features or in maintenance mode. Base annual maintenance of the app costs $20,000.

The goal is for HydroAssist® to work on an integrated service subsidization business model. We have made some steps in this direction. We already provide annual $2,500 subscriptions to nonprofit and industry partners to link their company websites to relevant products listed in the app. This has covered about 50% of current maintenance expenses. Other advertising opportunities (banners and push notifications) are poised to be added to the app and to diversify our subscription levels. There are new industry and non-profit partners that we have the opportunity to approach to grow this revenue stream.

In addition to marketing opportunities in the app, we want to focus on big data and the application of data visualization tools as a primary source of revenue-generating activities. We know there is a demand for access to the insights this data can provide. The data will become more valuable as we grow the user base. The data can be used to support research applications as well as pitches to angel investors for start-ups in this field. Access to data will be provided on a fee-for-service model. 

The ultimate goal is to expand the data set by connecting the various clinical and patient-provided databases that we own, thereby increasing the amount of queriable data available to key stakeholders. To fund this big data project, we will apply for government or technology grants. 

We believe these monetization efforts will make it possible for us to continue the current model, and still grow the capabilities of HydroAssist®.