To understand what’s working in methods and measures for mHealth research we conducted an informal review of funded research. Not a review of what’s been published, but what’s funded, by what agencies, what investigators and what condition or disease is funded. Search sites included NIH RePORT which is if you’re not familiar with the acronym is the NIH Research Portfolio Online Reporting Tools, clinical trials.gov (registration site for clinical trials), HSRProj (site which may list funding of government funding other than NIH, foundations, payors and includes research outcomes that are health services research in addition to patient clinical outcomes). Time period for the informal search was the previous 6 years for completed or current projects. Most federally funded projects are funded 3-5 years.
486 projects identified using search terms mobile, mobile health, telehealth. 29 were actually using some aspect of mobile health in the research intervention For a range of conditions: diabetes, HIV, obesity, cancer were top on the list followed by hypertension, patient compliance, physical activity, major depression, asthma, smoking, COPD Types of mobile interventions being evaluated included mobile phone, behavioral mobile technology, peer mobile phone, texting, SMS support, internet coaching, telemedicine (terms used by study investigators.
The importance of this informal search found that there is still not much in the pipeline of major federal funding for mobile intervention. Most major publications need to have funded studies before publication. The gold standard which is sought for better or worse is NIH funding, especially in academic medical research. The needle is beginning to move and there is great opportunity for innovators, industry and academic researchers to collaborate to move the needle further. My own observations are that the fastest pace as a business and collaborative research model, is being done by the National Cancer Institute through the SBIR, STTR funding mechanism, but the majority of projects are still more genomic and or pharma based interests. SBIRs/STTRs small funding, one –two years, take as much work as the larger NIH R01s. Encouraging are recent announcements by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), Technologies for Independent Living RFA and the NIH Office of Behavioral and Social Sciences recent call for white papers. If anyone is interested in working with my team on either of these project areas, please contact me.
When we started in 2006, deciding to focus on mobile diabetes health, NIH wasn’t interested, no pilot data. Our team sought funding from state of Maryland which encourages collaboration between industry and academic researchers. Many states have these funding programs to encourage academic-bbusiness partnerships with the ultimate goal in Maryland being job creation. Maryland is called the Maryland Industrial Partnerships (MIPS); fund average about $100,000 for a one year project, can be funded for second phase. Great for start-ups to receive additional business, legal, and technology resources. For the Academic researcher MIPS gives enough funding for a decent pilot study, proof of concept, publishable. Based on our work with the first company, WellDoc, we used MIPS funds to conduct a 30 subject study, published, providing pilot data to develop other proposals for funding. The funding for the larger RCT study, direct and indirect funding, came from Maryland Carefirst Blue Cross Blue Sheild, Lifescan, Sprint, and WellDoc through a research services agreement with the University of Maryland. Our team has a current third MIPS pilot funded with TelCare, a start-up also in the mobile diabetes space.
While working on the pilot and then with the results of the WellDoc pilot study, we put together a collaboration of funders. frankly because we knew there was interest and to go through the NIH writing and review process without a guarantee of success would take too much time. We also wanted to conduct a study to attempt to address the identified gaps in the research methods, many of which still exist and were mentioned yesterday. We decided to conduct a cluster randomized clinical trial, by enrolling physician practices, randomizing at the practice level and then patients were treated and followed based on the randomization assignment of the practice. This would allow us to have treatment fidelity. We also choose to conduct the study among community primary care provider practices where 90% of diabetes care takes place. “Real world as possible”. One year intervention so that we could study whether we could achieve change in diabetes status and would the behavior be sustained.
What works in measures for RCTs can be to identify the clinical gold standard. In diabetes research it’s hemoglobin A1c a measure of how well a person’s blood glucose has been maintained for the previous 3 months. Seems obvious to study the clinical gold standard but more interesting for where mobile health field is currently may be in the secondary outcomes. Of more interest for mobile health research is to understand not only if something works but how does it work. Most persons do not go around in everyday life and say I’m diabetic and I’d like to manage my disease. Persons are more likely to say to health providers or peers, I’d like to walk more but my feet hurt (clinically diabetes may cause neuropathies which cause pain and other sensations in feet). So in our study we identified secondary measures which might provide more information along secondary outcomes. Worked with Carlos DiClemente to create a Diabetes Behavior Stages of Change measure for the study. Just fortuitous Carlos is on faculty at a sister campus and the East Coast BJ Fogg. Provider and patient satisfaction- created our own. No good tools published.
Because there was so little in the research literature, my team wrote up the design of the study, published in Contemporary Clinical Trials. I’m sure you all have that journal on your coffee table and have read it! But it puts our methods out there for all to see….and critique. The results for the primary research outcome are in manuscript review and I hope to be published soon. So I can not discuss. We’re pleased by additional analyses we’ll be able to do, including a chance to study my passion for differences in outcomes by patient age. Hugh opportunity for mobile health to impact lives of aging population. Diabetes is a low hanging fruit, 10.9 million Americans, 65 and older have diagnosed and undiagnosed diabetes. 27% of this age group, making it the highest rate among all age groups. And older adults can and will use mobile health.
Themes we observed in the mobile intervention which work and we see more of this appearing in recent literature: Including expectations of persons with the condition or disease. Provide feedback that is actionable, not just data Continuous available feedback. Persons/patients choose to use when needed Linking actionable feedback between patients and providers is crucial for long term health behavior change.
In conducting our study and launching new studies, there are challenges in operationalizing the evaluations. In one respect we criticize the paucity of scientific evaluations and lack of metrics for mobile health. However, to change this do we have the patience to go through the time involved in conducting the large randomized clinical trials, similar to what the drug industry has done for years. For those who have not been through this process, writing and reviewing an R01 takes 12-18 months minimum. Every researcher expects to have the study rejected in it’s first NIH review, even for experienced full tenured researchers and the funding is getting tighter. Most large NIH RCTs take 3-5 years and another 1-2 to publish results. Technology will always be changing. Great example is the CMS demonstration completed a few years ago-$25-30 million using a large expensive telehealth monitor in patient homes. Improved diabetes outcomes but not cost effective. Studies which involving human subjects must go through Institutional Review Board Process (IRB), includes review of HIPAA protection. Very imporant but time consuming especially if a multi-site study may have multiple IRBs with different review approaches and time frames. Evolving issue is clear understanding and agreement on where data from mobile health studies resides, is protected and who can use. We’ve gone through a lengthy process to create a data use agreement which works for the mobile health companies, my university and my team research interests. There are challenges and opportunities for the collaborations among the mobile health industry, scientific community and payors.
My pearls I’d like to leave you with is to invest in asking not only does mobile health work but how does it work. That will move the needle for the industry and for persons and providers. And , to not be shy about your innovative thinking, if you build it, they will come. Thank you. I look forward to new collaborations.
M health summit 050511
What Really Works Methods and Measures for Research & Evaluation Charlene C. Quinn [email_address] 410.706.2406
What Really Works: methods <ul><li>Informal Systematic Review funded research </li></ul><ul><ul><li>Search sites NIH RePORT, clinical trials.gov, HSRProj, Federal agencies other than NIH including AHRQ and the VA </li></ul></ul><ul><ul><li>Previous six years </li></ul></ul>
What Really Works: methods <ul><li>Informal Systematic Review funded research </li></ul><ul><ul><li>486 projects identified </li></ul></ul><ul><ul><li>29 actual mobile health interventions </li></ul></ul><ul><ul><li>Types of mobile interventions varied </li></ul></ul>
What Really Works: methods <ul><li>Importance of informal search findings </li></ul><ul><ul><li>What’s in the pipeline? </li></ul></ul><ul><ul><li>Where is the focus of non-industry funded research? </li></ul></ul><ul><ul><li>Who is doing the research, potential collaborators? </li></ul></ul><ul><ul><li>What are the interventions, what measurement tools, what research design? </li></ul></ul>
What Really Works: methods <ul><li>Mobile Health Projects </li></ul><ul><ul><li>Funded pilots (3), state technology funds </li></ul></ul><ul><ul><li>Working with technology start-ups </li></ul></ul><ul><ul><li>RCT funded by industry partnership </li></ul></ul><ul><ul><ul><li>Technology start-up, major insurer, glucose meter company, wireless mobile phone company </li></ul></ul></ul>
What Really Works: methods <ul><li>Designing the clinical trial </li></ul><ul><ul><li>Randomized </li></ul></ul><ul><ul><li>Larger number study participants </li></ul></ul><ul><ul><li>One year intervention </li></ul></ul><ul><ul><li>Control group, stepped intervention (dose) </li></ul></ul><ul><ul><li>Enrolled providers and patients (cluster randomized trial) </li></ul></ul><ul><ul><ul><li>Community primary care providers </li></ul></ul></ul>
What Really Works: Measures <ul><li>Primary research outcome: mean change in HbA1c (a gold standard in diabetes research) </li></ul><ul><li>Secondary outcomes to explain if change in HbA1c </li></ul><ul><ul><li>Symptom measure (McColl) </li></ul></ul><ul><ul><li>Depression (PHQ-9) </li></ul></ul><ul><ul><li>Diabetes distress </li></ul></ul><ul><ul><li>Diabetes Stages of Change </li></ul></ul><ul><ul><li>Provider and patient satisfaction </li></ul></ul>
What Really Works: Evaluation <ul><li>Published a research design article describing the Mobile Diabetes RCT </li></ul><ul><li>Study results-primary research outcome in manuscript review </li></ul><ul><li>Working on analyses secondary outcomes, including </li></ul><ul><ul><li>Differences by age, race </li></ul></ul>
What Really Works: Evaluation <ul><li>Intervention themes observed </li></ul><ul><ul><li>Include expectations of persons with condition/disease </li></ul></ul><ul><ul><li>Feedback that is actionable </li></ul></ul><ul><ul><li>Continuous </li></ul></ul><ul><ul><li>Linked to health providers </li></ul></ul>
What Really Works: Evaluation <ul><li>Challenges to operationalize evaluations </li></ul><ul><ul><li>Gold standard for academic research is defined largely by NIH R01 standards </li></ul></ul><ul><ul><ul><li>Needed for FDA review? </li></ul></ul></ul><ul><ul><li>IRB understanding of mobile health and protection of human subjects </li></ul></ul><ul><ul><li>Where data resides. Industry servers not covered by IRB protection. </li></ul></ul><ul><ul><ul><li>Integrating server data with research data </li></ul></ul></ul><ul><ul><li>Collaborations mobile health industry, scientific community and payors-transparency </li></ul></ul>
What Really Works <ul><li>Not only ask if mobile health works, ask how does it work </li></ul><ul><li>If you build it, they will come </li></ul><ul><li>Charlene C. Quinn </li></ul><ul><ul><li>[email_address] </li></ul></ul><ul><ul><li>410.706.2406 </li></ul></ul>