Adhera Health Pioneers Family-Focused Digital Health Solutions for Children with Chronic Conditions

Reveals Transformative Research Results at ISPAD 2024

Adhera Health unveiled groundbreaking research at the International Society for Pediatric and Adolescent Diabetes (ISPAD) conference showcasing how innovative digital interventions can enhance wellbeing for families affected by Type 1 Diabetes (T1D) and childhood obesity.

The first study (NCT05483803), "Impact of a Personalized Digital Intervention on the Wellbeing of Caregivers of Children with Type 1 Diabetes and Diabetes Management," revealed a significant link between caregiver stress and the child's overall wellbeing. The findings underscore the critical importance of providing comprehensive support to the entire family in managing chronic conditions. The study enrolled 90 families of children with type 1 diabetes aged 8-15 years. Caregivers interacted with the Adhera® Caring Digital Program which emphasized education, provided motivational, gradual, and substantiable change recommendations along with a dedicated coach. Caregivers completed surveys on their own wellbeing and their child's quality of life at the start and end of the 3-month program.

Results showed a significant correlation between caregiver stress and poorer child wellbeing (r=-0.37, p<0.001), emphasizing the importance of addressing caregiver wellbeing. Post-intervention, the percentage of families reporting good wellbeing increased from 31.8% to 43.4%, while those with poor caregiver wellbeing decreased from 38.8% to 9.6%.

Adhera Health also presented initial findings from an ongoing study sponsored by the National Institutes of Health/National Institute on Minority Health and Health Disparities (1R43MD018551-01). The presentation was titled " Adaptation of a Digital Health Intervention for Chronic Condition Related Fatigue to the Latino Population.”

This research seeks to rigorously assess the acceptability of a digital intervention within the Latinx community and devise a tailored strategy for its effective implementation in urban Latinx neighborhoods. Adhera Health conducted over 15 participatory workshops, engaging more than 150 families and stakeholders, including parent groups from diverse backgrounds such as African American and non-Hispanic white families. These sessions provided critical insights into the unique needs and preferences of the Latinx population, establishing a foundation for culturally sensitive, community-driven solutions in chronic disease management. Latinx parents of children with T1D rated the Adhera Caring Digital Program positively (77.5-88), while parents of children with obesity scored even higher (94-100). All participants would recommend the program, describing it as "easy," "understandable," and "user-friendly."

"These findings validate our mission to adopting a holistic approach that supports the entire family unit,” said Ricardo C. Berrios, Co-Founder and CEO of Adhera Health. “Our research proves that personalized digital interventions significantly enhance caregiver wellbeing, which in turn enables families to more effectively manage their child’s chronic condition, ultimately leading to improved quality of life for the child and the family as a whole.”

Adhera Health is actively scaling its family-focused model to encompass a broader range of pediatric chronic conditions and communities across the US. Its vision is to ensure that all families of children with chronic illnesses have equitable access to innovative digital health solutions that are tailored to address their specific needs and improve health outcomes.

Adhera Health at HLTH 2024

Adhera Health's team will showcase live demonstrations of the Adhera Caring Digital Program at the Scale Health booth (#3210-13) at HLTH 2024, where attendees can experience how the program empowers families managing pediatric chronic conditions through engaging and personalized support.

This blog article is a reprint of the press release - https://www.einpresswire.com/article/750051619/adhera-health-pioneers-family-focused-digital-health-solutions-for-children-with-chronic-conditions

New Study Reveals Impact of Personalized Digital Companion on Caregivers of Children with Type 1 Diabetes

Adhera Health’s AI-Precision Digital Companion Improves Wellbeing of Caregivers for Children with Type 1 Diabetes

Groundbreaking research on the beneficial effects of Adhera Health’s AI-Precision Digital Companion on the wellbeing of caregivers of children with type 1 diabetes and its effectiveness to support personalized pediatric care is set to be unveiled at the 46th Congress of the Spanish Society of Pediatric Endocrinology – SEEP 2024.

Led by researchers from Hospital Universitario Miguel Servet and Adhera Health and sponsored by Novo Nordisk, this study (CARING-T1D) sheds light on the transformative potential of personalized digital interventions to enhance health outcomes for families managing chronic conditions. Building upon previous findings released at SEEP and other endocrinology conferences, the study underscores the pivotal role of personalized digital companions in providing tailored support, empowering caregivers, and driving positive engagement and behavior change to better integrate care for families affected by type 1 diabetes.

Dr. Antonio de Arriba, Pediatric Endocrinologist at the Hospital Universitario Miguel Servet and the principal investigator, will present the new findings at this year’s SEEP meeting, which takes place May 8 to 10, 2024, in Las Palmas de Gran Canaria (Spain).

“The findings highlight how Adhera Health’s personalized digital companion and interventions impact the wellbeing of caregivers and children with type 1 diabetes, revolutionizing pediatric healthcare by offering targeted support, educational content, and empowering the entire family unit,” remarked Dr. de Arriba, “This study illustrates the potential of delivering precision medicine that acknowledges the uniqueness of each family, which is essential in pediatric care for all conditions.”

Results of the new study demonstrate that a digital intervention program delivered by the Adhera AI-Precision Digital Companion had a positive effect on the overall wellbeing of the parents while also supporting integrated care via advanced AI algorithms. This means that the intervention not only positively impacted the parents’ emotional and psychological state but helped clinicians better understand the needs of families.

"The wellbeing of the entire family is paramount in managing diabetes effectively," emphasized Ricardo C. Berrios, co-founder, and CEO of Adhera Health. "Our study, alongside others we've conducted, highlights the importance of involving the whole family unit in the design of interventions and treatment plans for pediatric diabetes. It's crucial for healthcare strategies to address the needs of both children and their primary caregivers to achieve better health outcomes. Our findings support that data-driven solutions can help personalize pediatric care by considering the distinct needs of each family."

The study results also show that stratifying families based on the child’s metabolic control and the wellbeing of the caregiver provides a valuable approach for assessing the overall wellbeing of the family unit. By considering these factors together, healthcare professionals can gain a more nuanced understanding of the family’s health, and subsequently tailor interventions more effectively to meet the specific needs of each family.

This blog article is a reprint of the press release - https://www.einpresswire.com/article/709927170/new-study-reveals-impact-of-personalized-digital-companion-on-caregivers-of-children-with-type-1-diabetes

National Minority Health Month - Be the Source for Better Health

Since 2002, the National Institute on Minority Health and Health Disparities (NIMHD) has annually celebrated National Minority Health Month in April. This initiative traces its roots back to 1915 with the establishment of National Negro Health Week by T. Washington, marking a longstanding commitment to addressing disparities in healthcare access and outcomes*.

The FDA defines health equity as “the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, and other factors that affect access to care and health outcomes.” Despite strides made in awareness and policy, significant work remains to achieve this vision.

In the realm of digital health, there’s growing evidence of the positive impact digital tools can have on chronic condition self-management. However, studies indicate a concerning trend: low adoption rates among minority populations in the U.S., which often stem from poor adaptation of digital health solutions to minorities’ specific needs. This can be attributed to a systemic lack of involvement of minority groups in the design of these digital health solutions. Consequently, this is raising concerns about potential exacerbation of health inequalities.

Recognizing the potential of digital health solutions to improve health outcomes, Adhera Health prioritizes inclusiveness as a value in both our daily operations and our product development. We believe that personalized solutions tailored to the unique needs of health minorities are essential for achieving health equity. In line with this commitment, we were honored to receive a NIH/NIMHD award in September 2023 for advancing our Adhera Precision Digital Companionä platform for chronic conditions and adapting it to the U.S. Latinx population with the aim of reducing health inequalities.

Adhera Health is privileged to collaborate with Dr. Jennifer Raymond, MD, MCR, Chief of the Division of Endocrinology, Diabetes, and Metabolism at Children’s Hospital Los Angeles, on the NIH/NIMHD award. Dr. Raymond is enthusiastic about our project and is particularly eager to spearhead the clinical research on pediatric diabetes, encompassing the comprehensive care of both the physical and mental wellbeing of family caregivers of Latinx children with type 1 diabetes.

Dr. Raymond strongly advocates for leveraging digital health technologies to alleviate distress among young individuals with diabetes, particularly those residing in marginalized communities. A study published in 2023 by the Journal of Diabetes Science and Technology, led by Dr. Raymond and her colleagues, revealed that adolescents and young adults with type 1 diabetes who primarily engage in diabetes clinic visits via telehealth exhibit improved overall attendance and experience lower levels of diabetes-related distress compared to those attending in person.

To support our efforts and raise awareness, we encourage you to explore the Minority Health and Health Equity Resources Catalog, which offers a comprehensive list of resources available in multiple languages: https://www.fda.gov/consumers/minority-health-and-health-equity/minority-health-and-health-equity-resources

Together, let’s strive for a future where everyone has equal access to quality healthcare, regardless of their background or identity. 

Sources: 

* https://www.nimhd.nih.gov/programs/edu-training/nmhm/

Unlocking Insights with Kwame Ulmer: A Journey Through MedTech, FDA, and Venture Capital

This interview with Kwame Ulmer is part of a larger series of interviews where we discuss the intersection of healthcare and technology with subject matter experts from Adhera Health’s Advisory Board.

Kwame Ulmer leads MedTech Impact Partners (MIP), bringing over twenty years of experience evaluating medical technologies from both government and private sectors. In addition, Mr. Ulmer is a venture partner at Wavemaker Three-Sixty Health, the leading Southern-California based, early-stage venture capital firm focused on the healthcare industry. His career highlights include a 12-year tenure at the FDA in roles such as Deputy Director and Branch Chief, as well as serving as Vice President of Regulatory Affairs and Quality Assurance at Implant Direct, a subsidiary of Danaher Corporation. In addition to Adhera Health, Mr. Ulmer is a board member for Essenvia Inc. and Strados Labs Inc. He is a lecturer and researcher at the University of California, Los Angeles, and the founder of MedTech Color, a nonprofit aimed at enhancing the representation of persons of color in the medical device industry.

During your 12 years at the US Food and Drug Administration, you occupied leadership roles including deputy director and branch chief. How have the insights and challenges faced in these roles shaped your current approach at MedTech Impact Partners and Wavemaker 360 Health, specifically when advising startups on their journey through the FDA's rigorous evaluation process?

“There are a couple of ways my time at the FDA informed my decision-making afterward.” In his positions at the FDA, Mr. Ulmer was able to review a variety of products, “from medical devices to diagnostics, to digital health solutions – and a range of applications.” As Mr. Ulmer explains, the knowledge he gained at the FDA engaged him with “a sense of the core issues regarding establishing safety and effectiveness for any product and the basic processes and principles for evaluation that I could apply to a range of technologies when I left.”

Mr. Ulmer says that his time with the FDA taught him about the importance of knowing how to talk to the FDA. “What really became apparent after I left, was the impact of questions from the FDA and the activities that set off that accompany.” Companies put a lot of energy into “effectively responding to the FDA, and it really is a bit daunting.” When interacting with the FDA, “one has to be mindful, first of all, are the FDA asking the right questions, not having a whole laundry list of not critical or not germane or not necessary questions?” When you’re outside of the agency interacting with the FDA, you are working with companies “to effectively and efficiently answer their questions as quickly as possible, while using the right amount of resources in the organization and hopefully, not having the entire organization seize up.”

You have experience evaluating over 1000 medical technologies throughout your career. What patterns or trends have you observed in the evolution of medical technologies and how do these patterns inform your investment decisions at the venture capital level?

Mr. Ulmer explains how he has seen shifts in the medical technology industry over the last couple of decades.

“I’ll talk about the people and then the technology.” When Mr. Ulmer first began working in the regulatory space for medical technologies, he saw the same “teams” of individuals. “There was a leadership profile, and it was a clinician who had discovered a novel way to treat a pain point; sometimes they teamed up with a business-oriented person, and I would be sitting across the table with them talking about some safety or effectiveness issue. Now the profile is more diverse. It could be a former Google employee who found software to treat a mental health condition. It could be someone with no traditional medical device background at all who teams up with someone who came from pharma who wants to take a stab at the medical device industry.” While the type of entrepreneur has shifted somewhat, it still retains that traditional profile. 

“The other thing that has changed over the years is the agency's focus and the industry's focus on all aspects of software-related issues. 10 years ago, the vice president at the time was in danger of having his defibrillator hacked. So, cybersecurity has been around for over a decade for medical devices. It is only in the last three or four years that there has been staffing for FDA experts in software, specifically in cybersecurity, so it has become one of the last elements of holistically established safety effectiveness. So, that is another megatrend: software as a medical device and software in a medical device, and the FDA having the capability to address it in terms of safety and effectiveness.”

What resources exist within the FDA, in terms of technical and technology knowledge, to address the rapid development of tech? For example, for generative AI applied to health care – how can they keep up with new advances?  

“Yeah, it’s a challenge.” says Mr. Ulmer. “This is from reading the publicly available data about how the FDA is responding: number one, an unintended consequence of the pandemic is that there was a surge in staffing these for the FDA to get emergency-use authorizations through effectively.”

The staffing requirement is still there, “in the latest user fund negotiation, the FDA asked for additional staff. I think those staff are still coming online.” Specifically, explains Mr. Ulmer, “software experts are still coming online,” who can be difficult to find because those individuals have a lot of career options, especially in the private sector. “So that is a challenge. Getting that top talent who can address issues like cybersecurity.”

You have great experience overseeing various aspects of fund management, from deal sourcing to advising portfolio company management teams. What pitfalls do you observe startups taking in the MedTech space, and how do you leverage your experience to guide them? 

“Over the years, I've been fortunate enough to establish relationships with the key stakeholders that are needed to build a high quality, safe, and effective medical device, med tech solution, and early on for rarely reasonable reasons, the founding team doesn’t always have access to all the experts that they need. So, a pitfall is not having, within arm's reach: the biostatistician, the clinician, the cyber expert, the biocompatibility experts – all the key team members you need to establish a proof of concept, and later safety and effectiveness. And that's obviously an issue of funding.”

Another pitfall is “companies not knowing, through really any fault of their own, not just that non-dilutive capital like NIH and NSF funding is there, but that most companies do not successfully get their grant approved on the first go around. It normally takes a couple of attempts to get that first a hundred thousand. And then for phase two, you know, for over a million dollars.”

As one of the founders of MedTech Color, you've made a significant effort to advance the representation of persons of color in the medical device industry. What challenges and gaps do you perceive that led to the establishment of this nonprofit? And how do you envision the future of diversity within the medical technology sector?

“The first gap, that was born out of my personal experience and the experience of other executives in the industry, was that it was a lonely experience – which impacted retention.” When people don’t feel a sense of community they tend to leave. “That was something I was dealing with professionally at the time. And so MedTech Ccolors originally was intended to build community, and we did that over the years. We have a network of over 43000 people from a range of ethnic groups and allies.”

In the time Mr. Ulmer spent as a consulting partner, he found that “early-stage companies with diverse teams, despite being more likely to have outsized returns, were not receiving commensurate capital – early-stage investment.” So, he helped to create a pitch competition “to serve as a magnet to attract additional capital from other sources like the NIH and the NSF, their partners for this pitch competition, but also large private companies who could buy strategically aligned companies to enter into their corporate accelerators.”

“So,” says Mr. Ulmer, “those are two examples, community and capital, that are a problem in the industry, and how MedTech Color aims to solve those problems.”

Adhera Health recently won an award specifically to address certain underserved populations in this U.S. and we understand that we still have a long road to a truly equitable future. Have you seen progress since you began MedTech Color?   

“First, I think of four key stakeholders for this to be successful. One is the startups. And I'll give you a brief example. Over the last four to five months, we've seen at least five to six companies focused specifically on treating women going through menopause. That's great, the startup is trying to solve the problem there. The second element to success would be organizations in the government that could provide non-dilutive capital. Right now, there are a handful of sources of capital where you can focus on health equity. The National Institutes for Aging has a challenge where you can address health equity and receive a grand prize. And then, you have the venture capital community. If you look at just women's health investment, it's been flat, so we haven't seen a lot of activity there. And so, the fourth element is a nonprofit community and MedTech Color and MedTech Women are there to serve as a beacon for talent focused sometimes on health equity.” And while Mr. Ulmer believes these organizations are growing and thriving, “the hard truth is the venture capital dollars have not been increasing as much as they could be. And there are some early programs focused on health equity from the government side, but there's still a-ways to go for those two communities.”

Drawing from your experience as a lecturer and researcher at the UCLA Anderson School of Management, as well as your experience as a board member for the University of Virginia’s Licensing & Ventures Group, how do you see the role of academia in shaping and supporting the future of the med tech industry? And how do you ensure that the knowledge and innovations from these academic platforms transition effectively into real-world applications? 

“There are two elements that I've observed for the successful translation of great ideas out of the university and into the private sector to reach patients. One is capital; larger research institutions like UCLA have wonderful innovation funds that can make significant investments to get companies to the prototype stage by de-risking regulations – sometimes even with reimbursement. Those early-stage questions that any company would need to face – they can get the capital before they even form a company through these innovation funds. So, at the University of Virginia where I went to school, there's a seed fund that plays that role. Sometimes they invest alongside angels. And then at UCLA, there's an innovation fund. So, the capital is one piece and that's the role that university should play.” 

Mr. Ulmer explains further, “The other, beyond capital, is the university incentivizing professors to be able to work on these products beyond just a six-month sabbatical. This is hard,” laughs Mr. Ulmer, “but if it can be written, this should be written into the policies and procedures as to what is a factor for getting on tenure track or getting promoted; if part of the incentive for the factors that are considered to promote a faculty member could be formation of entrepreneurial projects, that would be the other major lever. And we talked about that some at the University of Virginia. How do we incentivize faculty to really be entrepreneurial? It's by saying this is a factor in your promotion.”

Why did you choose to join the Adhera Health Advisory Board and what do you see as Adhera Health’s top contributions to the current state of person-centric digital health platforms?  

“Early on at the fund that I work at, and by nature of my work outside of the fund. We started thinking about megatrends, and one megatrend is personalized solutions. Some people call it personalized medicine. There are other terms, but fundamentally more and more software-enabled solutions are targeting the person, and it was really intriguing to be able to be associated with a company like Adhera Health which is focused on a personalized solution. As the company grew and established markets and patients to reach, I had a personal connection to the potential future ability to impact patients with autoimmune diseases because it has directly impacted my family. And professionally, I'm attracted to companies with diverse leadership teams, and that's immediately what I saw when I met you and got to know other members of the team,” he says, speaking to Ricardo Berrios, CEO of Adhera Health, “and I thought that that was going to be an advantage for you moving forward. So, for those reasons and many more, I'm delighted to be associated and work with you, Ricardo, and the company. There is going to be an amazing impact on patients, and I'm just delighted to be with you on this journey.”