IntroductionThe rapid growth of mobile health (mHealth) devices holds substantial potential for improving care and care outcomes in aging adults with chronic non-cancer pain (CNCP), however, research evaluating these devices in older adults remains limited.ObjectiveTo ascertain the feasibility and preliminary efficacy of an mHealth intervention (Mymee) that combines symptom, diet, and behavior tracking via a smartphone application with data analytics to detect associations between symptoms and lifestyle factors along with weekly health coaching sessions to mitigate CNCP in adults 55 years of age and older.MethodsParticipants (N = 31) in this pilot study were recruited from one primary care practice in New York City and randomized to an intervention [app + up to 12 health coaching sessions (scheduled approximately once weekly) + usual care] or a control (app + usual care) arm. Feasibility measures included recruitment (proportion of eligible persons who enrolled) and retention rates (proportion of subjects completing a follow-up assessment) as well as adherence with the weekly coaching sessions and logging daily data on the app. Efficacy outcomes (e.g., pain intensity, self-efficacy, disability, anxiety) were assessed at baseline and follow-up (~16 weeks after baseline). Descriptive statistics were obtained and general linear mixed models used for primary analyses.ResultsParticipants had a mean (standard deviation) age of 67.32 (9.17) and were mostly female (61%). Feasibility outcomes were mixed as evidenced by recruitment and retention rates of 74% and 65%, respectively. The mean number of weekly coaching sessions attended by intervention participants was 6.05 (SD = 5.35), while the average number of days logging data on the app was 44.82 (34.02). We found a consistent trend in favor of the intervention, where pain intensity, affect, and quality of life measures improved considerably more among intervention (vs. control) participants. Finally, the proportion of participants with GAD-7 scores at follow up decreased by 0.35 to 0, whereas controls did not change, a significant effect in favor of the intervention (p = 0.02).ConclusionsThis study supports the need for future research that seeks to enhance feasibility outcomes and confirm the efficacy of the Mymee intervention among aging adults with CNCP.

Systemic lupus erythematosus (SLE) is a complex, multi-system autoimmune disease of unclear etiology that causes significant morbidity and, in severely affected patients, early mortality. Despite efforts from academic and private research entities, pharmaceutical companies, and patient advocacy groups, and hundreds of millions of dollars in spending, numerous gaps in care still exist. A digital therapeutic platform is described that uses self-tracking technology, analytics, and telehealth coaching to identify and remove possible dietary and/or other lifestyle triggers of SLE. A clinical proof of concept study was performed with 18 SLE patients over a 12 week program. All participants reported improvements in their symptoms, including pain, fatigue, digestive, and other physical symptoms. Clinical Relevance-This study demonstrates the technical and clinical feasibility of a digital therapeutic platform to improve the health-related quality of life in patients with systemic lupus erythematosus.

BACKGROUND There is increasing evidence that digital therapeutic tools can bring personalized medicine to the masses improving outcomes and decreasing cost. Many factors influence the expression of autoimmune disease, and understanding and removing these underlying triggers provides an opportunity to minimize use of medications and some patients can achieve sustained remission if the right triggers for a patient are identified. This randomized controlled trial is the first to test the efficacy of a digital therapeutic intervention which combines adaptive patient generated health data tracking with health coaching to identify factors triggering lupus and to evaluate reductions in symptoms, and improvements in quality of life. OBJECTIVE Evaluate impact of personalized dietary and environmental interventions on quality of life and health care costs. METHODS This a randomized controlled trial using a convenience sample. The Mann-Whitney U test determined that a sample size of 40 patients (20 intervention and 20 control) provides a power of 80% for continuous and ordinal variables. The Bonferroni Correction was used to ensure that the probability of a type 1 error is less than 5% even with the large number of hypotheses being tested. Subjects in both groups received standard of care from their physicians. All subjects repeated the online questionnaires (Fatigue Scale - FACIT, Lupus QOL, and BPI-SF) at weeks 4, 8, 12, and 16. The experimental group going through the mymee protocol received health coaching (weekly calls to educate and implement changes based on data analysis). Digital data collection and tracking was used to correlate dietary/lifestyle/environmental patterns with symptoms. The control group completed the same assessments during the 16 week intervention period but did not receive any additional coaching. The intervention uses correlations between symptoms and triggers that are reported daily to create an iterative cycle of hypotheses tailored to each individual. With 5 min of tracking a day using the app, patients easily report what they have eaten, other triggers, and their symptoms. Using our machine learning platform, coaches identify each patient’s personal disease triggers and help patients implement changes to remove them. RESULTS The interim results of the study showed that 78% improved in the experimental group and 36% in the control group with a P<.01. Furthermore, 67% of the patients have gone off some or all of their drugs after consulting with their doctors. CONCLUSIONS Results show a significant improvement for lupus patients who completed the protocol, demonstrating the potential for digital therapeutics to dramatically improve the quality of life for patients diagnosed not only with lupus, but other chronic diseases (80% of the trial patients also had rheumatoid arthritis). Broad adoption of the mymee intervention could assist in building a database of lupus triggers and symptoms that could lead to further understanding the causes of lupus. Based on interim results, a 78/36 effect size is competitive if not more effective than current drugs in the pipeline like Stelara which shows a 60/31 effect size and includes potential side effects of drug-induced MS and cancer.

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