Press category: Mobile Health

SEATTLE & NEW YORK–(BUSINESS WIRE)–Sage Bionetworks, a nonprofit biomedical research organization, in collaboration with The Michael J. Fox Foundation for Parkinson’s Research (MJFF) today announced the launch of Parkinson mPower (mPower), a patient-centered, iPhone app-based study of symptom variation in Parkinson’s disease.

mPower (Mobile Parkinson Observatory for Worldwide, Evidence-based Research) uses the new ResearchKit software framework announced today by Apple to make it easy for people with Parkinson’s disease to contribute data to researchers investigating symptom variation. ResearchKit turns iPhone into a powerful tool for medical research by enabling participants to complete tasks or submit surveys right from the mPower app. This new software framework delivers a simple way to present study participants with an interactive informed consent process, which helps explain the study’s purpose, how data will be used and the app’s privacy policy.

MJFF also announced the launch of Fox Insight, a Web-based virtual clinical study open to individuals of any age, both with and without Parkinson’s disease, worldwide. Later this year, data collected from participants who enroll in both mPower and Fox Insight will be used to validate the power of these two approaches in accelerating Parkinson’s disease research.

“MJFF recognizes patients and their families and loved ones as vital partners in Parkinson’s research,” said Todd Sherer, PhD, chief executive officer of MJFF. “Technologies such as ResearchKit, in combination with the mPower app and Fox Insight study, expand the opportunity for these key stakeholders to propel research forward by contributing data from their daily experience.”

mPower: App-Based Study of Parkinson’s Disease Variation

mPower is a unique, iPhone app-based study developed in collaboration with Ray Dorsey, MD, at the University of Rochester and Max Little, PhD, at Aston University, United Kingdom. By combining surveys and tasks that make use of iPhone sensors to collect data on abilities affected by Parkinson’s disease, including dexterity, balance/gait, and certain vocal characteristics, mPower aims to offer insight into the variability of Parkinson’s. The study will also highlight how mobile devices and sensors can help measure the disease and its progression, advancing research and care practices and ultimately helping to improve quality of life for people with Parkinson’s.

“Researchers who have made the effort to work together in the kinds of communities enabled by Sage’s platforms are becoming massively more productive,” said Stephen Friend, MD, PhD, president of Sage Bionetworks and mPower principal investigator. “But we need more data. In a traditional clinical study, you’d be thrilled to find 500 research ‘subjects.’ But imagine what is possible when you can quickly and reliably activate 20,000 research ‘partners.’ More importantly, participants need to be equal partners and be able to track changes in their own symptoms. It is through sharing insights and data among patients and researchers that we all find ‘windows of intervention.’”

mPower will collect real-time, objective data through a series of well-validated tasks. The app will remind users to complete the tasks before and after taking medication, and at the end of each day. The study also will collect additional patient-reported data, such as from wearable devices and surveys.

“We know that Parkinson’s disease symptoms fluctuate over the course of a day, or a week, but that has never been measured objectively,” said Dorsey, co-director of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center. “The mPower study will enable us to learn from patients, and we’ll be able to give information back to patients so they can manage their conditions regardless of where they live and regardless of their mobility.”

Sage Bionetworks is a strong proponent of open-source innovation. As such, participants in the mPower study can choose to make their data available for future studies conducted by researchers worldwide.

In addition to Dorsey and Little, Sage Bionetworks, led by senior physician Andrew Trister, MD, PhD, was advised in development of mPower by Karl Kieburtz, MD, MPH, at the University of Rochester, Caroline Tanner, MD, PhD, at the University of California San Francisco, and Bas Bloem, MD, PhD, at Radboud University Medical Centre in Nijmegen, the Netherlands.

mPower is available for download today on the App Store. The mPower study is open to all U.S. residents over age 18, regardless of a diagnosis of Parkinson’s disease.

Fox Insight: The Patient Experience Fueling Research

Fox Insight (foxinsight.org) is a virtual clinical study aiming to gather an unprecedented dataset and provide research with a holistic view of the lived experience of Parkinson’s disease. Fox Insight seeks to collect user-generated data gathered initially through surveys and “virtual clinic visits.” Over time, the site will evolve to work in concert with apps such as mPower, wearable computing, and other emerging technologies for increasingly passive and non-burdensome data collection from patients and control volunteers around the world. The study is open to any Parkinson’s patient with a computer and access to the Internet, as well as to individuals who do not have Parkinson’s disease.

The goal is to capture and analyze clinical data that can contribute to broader understanding of Parkinson’s, help establish reliable outcome measures for drug development, replace outdated clinical patient assessments and accumulate critical masses of data large enough to reveal previously undetectable aspects of PD and open up new avenues of PD research.

Core to the MJFF philosophy, all data collected through Fox Insight will be de-identified and made available to researchers worldwide for independent studies. Making this data available to the research community at large can rapidly accelerate progress by reducing cost and effort spent across individual projects and promoting replicable results.

mPower/Fox Insight 2015 Combined Study

Later in 2015, MJFF and Sage Bionetworks, along with Sage’s mPower collaborators, will jointly conduct a study of participants contributing data through both mPower and the Fox Insight platform. The combined study aims to amplify the voice of Parkinson’s patients and elevate their role as partners in research.

mPower participants with a diagnosis of Parkinson’s disease will be given the opportunity to consent to provide their data to the combined study. Additionally, MJFF will make Fox Insight users aware of the opportunity to download the mPower app and participate in the combined study.

Pending results of the combined study, MJFF will further develop and customize mPower to leverage the potential synergies of the mPower mobile app study platform and the Fox Insight platform.

A Commitment to Developing Emerging Technologies for Patient Benefit

Sage Bionetworks works to redefine how complex biological data is gathered, shared and analyzed. Through Sage’s efforts, patients and researchers become partners and together accelerate discoveries for patient benefit.

The Michael J. Fox Foundation is committed to developing emerging technologies for the benefit of Parkinson’s patients. In August 2014, the Foundation announced a collaboration with Intel Corporation to develop big data analytics and wearable technologies to speed Parkinson’s drug development. This ongoing effort is an important step in enabling researchers and physicians to measure progression of the disease and to speed progress toward breakthroughs in drug development.

 

Press Release on BusinessWire

SEATTLE–(BUSINESS WIRE)–Sage Bionetworks, a nonprofit biomedical research organization, together with collaborators Ray Dorsey, MD, at the University of Rochester and Max Little, PhD, at Aston University in the United Kingdom, today announced the launch of Parkinson mPower (“mPower”), a patient-centered iPhone app-based study of symptom variation in Parkinson’s disease. The study is sponsored by Sage with funding from the Robert Wood Johnson Foundation.

mPower uses the new ResearchKit software framework announced today by Apple to make it easy for researchers to gather data more frequently and more accurately from participants using iPhone apps. ResearchKit enables participants to easily complete tasks or submit surveys right from the mPower app and delivers a simple way to present participants with an interactive informed consent process. mPower utilizes Sage Bionetworks’ Bridge server platform.

“One reason to build these apps and run these studies is to see whether we can turn anecdotes into signals, and by generating signals find windows for intervention,” said Stephen Friend, MD, PhD, president of Sage Bionetworks and mPower principal investigator. “We’re most interested in disease variations, and the hourly, daily, or weekly ebb and flow of symptoms that are not being tracked and completely missed by biannual visits to the doctor.”

“Researchers who have made the effort to work together in the kinds of communities enabled by Sage’s platforms are becoming massively more productive,” said Friend. “But we need more data. In a traditional clinical study, you’d be thrilled to find 500 research ‘subjects.’ But imagine what is possible when you can quickly and reliably activate 20,000 research ‘partners.’ More importantly, participants need to be equal partners and be able to track changes in their own symptoms. It is through sharing insights and data among patients and researchers that we all find ‘windows of intervention.’”

mPower will use technologies in iPhone to collect real-time, objective data through a series of well-validated tasks designed to assess and measure tremor, balance and gait, certain vocal characteristics, and memory, before and after taking medication and at the end of each day in a large and diverse set of Parkinson’s disease patients. The study will collect additional patient-reported data, including data from wearable devices and surveys. The data-collection tasks were pioneered and validated by Max Little, PhD, a mathematician and lecturer at Aston University.

“We know that Parkinson’s disease symptoms fluctuate over the course of a day, or a week, but that has never been measured objectively,” said Ray Dorsey, MD, Professor of Neurology and Co-Director of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center. “The mPower study will enable us to learn from patients, and we’ll be able to give information back to patients so they can manage their conditions regardless of where they live and regardless of their mobility.”

The University of Rochester Medical Center is home to one of nation’s largest Parkinson’s disease programs. Approximately 100 individuals – physicians, scientists, and research staff – are involved in both treating patients with the disease and investigating new therapies. Over the last 30 years, researchers there have played a leading role in helping bring to market four new drugs to treat Parkinson’s. Dr. Dorsey has been a pioneer in the use of telemedicine to increase access to specialized care for individuals who suffer from the disease. The new app is an extension of these efforts to empower people with Parkinson’s to participate in research and help scientists and clinicians develop a more complete understanding of the disease.

“We hope the mPower app will re-engage a person with Parkinson’s disease, and by that engagement research partners will begin to notice things about the patterns of their disease and interventions,” said Andrew Trister, MD, PhD, senior physician at Sage Bionetworks. “Once we understand more about the daily lives of people living with Parkinson’s, and those modulators that might make a person feel better or feel worse, then that knowledge can be applied by others.”

“Physicians who dedicate their lives to improving the quality of life for people with Parkinson’s still have no idea how patients are actually functioning at home,” said Professor Bas Bloem, MD, PhD, medical director of the Parkinson’s Center of Excellence at the Radboud University Medical Center in Nijmegen, The Netherlands. “mPower will, for the first time, give us a real perspective on patients’ everyday functioning so we can deliver much better, tailored care.”

“If you are carrying around an iPhone, you are carrying around the potential to collect a great deal of information about yourself and about your health,” said Arno Klein, PhD, director of neuroimaging and SIMPL(E), which seeks and interprets meaningful patterns and latent explanations in data, at Sage Bionetworks. “We know so little about symptom variation in Parkinson’s disease, and so the point of this project is not to presume to know exactly what data to collect from a patient according to a pre-specified hypothesis, but instead to work with patients to learn about the disease, with the app serving as an intermediary.”

Beyond improving individuals’ health, the data generated by mPower could enable researchers to decrease the costs associated with future Parkinson’s disease clinical trials by better understanding disease phenotypes. “What might now need to be a multi-year study involving a thousand patients might become a shorter study involving fewer patients, if one really understood the subtle fluctuations of individuals’ disease and how those individuals broke out into subpopulations, and were able to look at the derivative of those fluctuations,” said Friend.

“There is untapped, latent demand for tools by which individuals can measure the course of their disease and get feedback on how they’re doing,” said Dorsey. “To have a dedicated Parkinson’s disease app backed by validated research, that will allow patients to engage with their care and get feedback on their condition, is amazing. And to make that data, in the aggregate, publicly available for research is heartening. Five years ago it would have been inconceivable.”

“A Parkinson disease patient is more likely to know his or her cholesterol number than their tremor score, and many Parkinson’s patients aren’t regularly seen by a neurologist. But if a patient that might not be very mobile, or who lives far from a specialist, can use an app to figure that out, independently of having to go to the doctor’s office and fill out three thousand forms, that’s a major advance,” said Dorsey.

Press Release on BusinessWire

SEATTLE–(BUSINESS WIRE)–A unique iPhone app introduced today is the basis for a research study that will allow participants and researchers to create better, more effective strategies to enhance breast cancer patients’ quality of life. This new app can help women track the physical, mental, and emotional after-effects of breast cancer treatment.

Using iPhone sensors and participant surveys, the Share the Journey: Mind, Body, and Wellness after Breast Cancer app tracks five common issues related to breast cancer treatment: fatigue, cognitive difficulties, sleep disturbances, mood changes, and reduction in exercise performance.

Share the Journey uses the new ResearchKit software framework announced today by Apple to make it easy for researchers to gather data more frequently and more accurately from participants using iPhone apps. ResearchKit enables participants to easily complete tasks or submit surveys right from the Share the Journey app and delivers a simple way to present participants with an interactive informed consent process.

Share the Journey is being developed by the nonprofit biomedical research organization Sage Bionetworks in collaboration with leading breast cancer researchers and global cancer institutions, including Patricia Ganz, MD, at the University of California Los Angeles, Kathryn Schmitz, PhD, MPH, at the University of Pennsylvania, and Ann Partridge, MD, MPH, at Dana-Farber Cancer Institute. The study, which will be continually improved based on feedback from participants, is sponsored by Sage with funding from the Robert Wood Johnson Foundation.

Share the Journey will be launched with essential support and guidance from the breast cancer community, chiefly the breast cancer organizations Susan G. Komen, Breastcancer.org, the Avon Foundation for Women, and Dr. Susan Love Research Foundation. The iPhone app-based study can transform the way research is conducted in a community that is clearly motivated to participate in projects for patients’ shared benefit and the mutual value of everyone affected by breast cancer.

Women who have undergone surgery, radiation, or drug therapy to treat breast cancer may experience symptoms that affect quality of life and impede recovery. Participants in Share the Journey may choose to set personal exercise goals and write about activities that positively or negatively affect their symptoms.

Collecting women’s experiences after breast cancer treatment in this unique, patient-centered study can create a trove of data based on well-validated surveys and measurements which can be analyzed for insights that can be relayed back to the breast cancer community. Participants will also be asked for feedback on how to enhance the study or better reflect their interests. In all, these tasks and surveys should take no more than 20 minutes per week, and women can participate in every aspect of the study or in only elements of their own choosing. They also can decide if they want to make their non-identifiable data available only to Share the Journey investigators or to qualified researchers worldwide working to solve puzzles in the area of breast cancer and beyond.

“Researchers who have made the effort to work together in the kinds of communities enabled by Sage’s platforms are becoming massively more productive,” said Friend. “But we need more data. In a traditional clinical study, you’d be thrilled to find 500 research ‘subjects.’ But imagine what is possible when you can quickly and reliably activate 20,000 research ‘partners.’ More importantly, participants need to be equal partners and be able to track changes in their own symptoms. It is through sharing insights and data among patients and researchers that we all find ‘windows of intervention.’ In the pool of spontaneous thoughts and anecdotes that come from individuals are precious insights on how to improve or speed recovery from these symptoms.”

Share the Journey is open to women in the U.S. between the ages of 18 and 80, with or without a history of breast cancer. Women without a history of breast cancer will contribute important data to Share the Journey that will help researchers understand which symptoms may be related to previous cancer treatment and which may be part of the normal aging process. A Spanish-language version of the app and efforts to expand the study to additional geographies are under development. Sage Bionetworks and its collaborators are also working to extend the study to include men who have been treated for breast cancer.

“We know that women and men face significant life changes after breast cancer therapy that they often don’t talk about,” said Judith A. Salerno, MD, MS, president and CEO of Susan G. Komen. “For some, there are patterns that they may not even notice, or that they dismiss, which affect their quality of life. This app gives them the ability to chart their individual progress and setbacks, all while contributing to a larger body of knowledge that will help all breast cancer patients in the future.”

“After the initial breast cancer treatment is completed, far too little attention is paid to the factors that can significantly impact a woman’s survivorship which include adhering to a long-term treatment plan and making healthy lifestyle choices,” said Marisa C. Weiss, MD, president and founder, Breastcancer.org. “If we can better understand how the side effects of treatment interfere with a woman’s various activities and her quality of life, we can provide smarter solutions to help extend and improve her life beyond breast cancer.”

Breastcancer.org provides millions of women affected by breast cancer with personalized expert medical information and support to enable the best possible decisions and outcomes.

“Share the Journey will provide real-world data after breast cancer treatment,” stated Marc Hurlbert, PhD, executive director, Avon Foundation for Women. “This new study and app is important for all women facing breast cancer, especially for those with metastatic disease who are often on one treatment regimen with its side effects, and then as those treatments fail, they are switched to a new regimen with a new set of physical, mental, and emotional issues.”

“Share the Journey is an important milestone in patient-centered research,” said Dr. Susan Love, chief visionary officer, Dr. Susan Love Research Foundation. “Our Army of Women volunteers stand ready to participate in new research that will benefit all patients. And we look forward to comparing Share the Journey results with our own patient-reported research on the Collateral Damage of treatment through our Health of Women [HOW] Study™.”

In addition to Patricia Ganz, Kathryn Schmitz, and Ann Partridge, Sage Bionetworks, led by senior physician Andrew Trister, MD, PhD, was advised in development of Share the Journey by Judy Garber, MD, MPH, at Dana-Farber Cancer Institute, and Susan Love, MD, MBA, chief visionary officer of Dr. Susan Love Research Foundation.

Press Release on BusinessWire

SEATTLE–(BUSINESS WIRE)–Sage Bionetworks, together with collaborators Patricia Ganz, MD, at the University of California Los Angeles, Kathryn Schmitz, PhD, MPH, at the University of Pennsylvania, and Ann Partridge, MD, MPH, at Dana-Farber Cancer Institute, today announced the launch of Share the Journey: Mind, Body, and Wellness after Breast Cancer, a patient-centered, iPhone app-based study of the causes of symptom variations in the breast cancer community. The study is sponsored by Sage with funding from the Robert Wood Johnson Foundation.

Share the Journey uses the new ResearchKit software framework announced today by Apple to make it easy for researchers to gather data more frequently and more accurately from participants using iPhone apps. ResearchKit enables participants to easily complete tasks or submit surveys right from the Share the Journey app and delivers a simple way to present participants with an interactive informed consent process. Share the Journey utilizes Sage Bionetworks’ Bridge server platform.

Women who have undergone surgery, radiation, or drug therapy to treat breast cancer may experience symptoms that affect quality of life and impede recovery. Participants in Share the Journey will be prompted to set personal exercise goals and write about activities that may positively or negatively affect their symptoms. By collecting this and other data from iPhone sensors, participant surveys, and health diaries, Share the Journey tracks five common consequences of breast cancer treatment: fatigue, cognitive difficulties, sleep disturbances, mood changes, and reduction in exercise performance.

Participants will also be asked for feedback on how to enhance the study or better reflect their interests. These tasks and surveys should take no more than 20 minutes per week, and women who take part can participate in every aspect of the study or in only elements of their own choosing. Collecting women’s experiences after breast cancer treatment in this unique study can create a trove of data based on well-validated surveys and measurements continuously improved upon based on feedback from study participants.

“One reason to build these apps and run these studies is to see whether we can turn anecdotes into signals, and by generating signals find windows for intervention,” said Stephen Friend, MD, PhD, president of Sage Bionetworks andShare the Journey principal investigator. “We’re most interested in disease variations, and the hourly, daily, or weekly ebb and flow of symptoms that are not being tracked and completely missed by biannual visits to the doctor.”

“Researchers who have made the effort to work together in the kinds of communities enabled by Sage’s platforms are becoming massively more productive,” said Friend. “But we need more data. In a traditional clinical study, you’d be thrilled to find 500 research ‘subjects.’ But imagine what is possible when you can quickly and reliably activate 20,000 research ‘partners.’ Similarly, gathering data a few times per year is the traditional gold standard, so imagine the possibilities when we are able to gather data continuously, all the time.”

Share the Journey is open to women in the U.S. between the ages of 18 and 80, with or without a history of breast cancer. Women without a history of breast cancer will contribute important data to Share the Journey that will help researchers understand which symptoms may be related to previous cancer treatment and which may be part of the normal aging process. A Spanish-language version of the app and efforts to expand the study to additional geographies are under development. Sage and its collaborators are also working to extend the study to include men who have been treated for breast cancer.

“Because of the successes of early detection and better cancer treatments, we’ve created a situation where there are now 14 million cancer survivors, many of whom will live for decades as a brand-new chronic disease population,” said Kathryn Schmitz, PhD, MPH, Professor of Epidemiology, University of Pennsylvania Perelman School of Medicine. “Patients don’t often know they should be expecting these sometimes persistent adverse effects. They don’t know, or they simply believe that it’s just what they should expect and there’s nothing that can be done about it. The Share the Journey app is a tool that may help breast cancer survivors become more empowered to care for themselves.”

“We need to better understand some of the long-term negative treatment effects, such as fatigue, that can be associated with the disease control benefits of cancer therapies. What are the biological mechanisms that underpin those effects and why some survivors are more vulnerable to those effects than others,” said Patricia Ganz, MD, professor at the UCLA Fielding School of Public Health and Director of Cancer Prevention & Control Research at UCLA’s Jonsson Comprehensive Cancer Center. “With Share the Journey, women can tell us when something’s wrong, and the app has the potential to capture valuable information on the patient experience. Our current cancer care system lacks the ability to predict or treat these chronic and enduring symptoms, but Share the Journey can set us on a path toward understanding why some people recover and some do not.”

“This is a beautiful marriage of technology and medicine, and a potentially extraordinary resource for research and for learning about how what people are doing day-to-day may affect their post-treatment symptoms,” said Ann Partridge, MD, MPH, Founder and Director, Program for Young Women With Breast Cancer, Director, Adult Survivorship Program, and Senior Physician at Dana-Farber Cancer Institute. “For breast cancer survivors, this is an opportunity to work on improving health by harnessing a technology that is already part of their daily lives, where their experiences can be shared with the broader breast cancer community so they can support each other and learn from each other.”

“Dana-Farber is very excited about any tool designed to help survivors map out a clearer plan for living well after cancer. For our patients in particular, this tool holds the potential to be a strong complement to Dana-Farber’s existing survivorship services, which help survivors build an exercise plan, improve sleep habits, learn mindfulness techniques, and much more. We are also excited to learn in real-time from the experiences of patients using the app, which will be a very powerful research tool to ultimately improve how we counsel patients about what helps and what doesn’t help after cancer treatment,” said Partridge.