Advancing clinical trials in nursing homes: A proposed roadmap to success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Stakeholders' views on priorities essential for establishing a supportive environment for clinical trials in nursing homes.

BACKGROUND: The U.S. clinical research enterprise in nursing homes was unprepared to mount clinical trials in nursing homes to address urgent questions relevant to prevention and treatment during the COVID-19 pandemic. We identify priorities essential for establishing a supportive environment for future clinical trials in nursing homes. METHODS: Two cross-sectional online questionnaires were administered between January and February 2021. One was administered to nursing home providers, researchers, and policymakers; respondents rated the importance of attributes of researchers, facilities, leaders and staff for conducting clinical trials in nursing homes. Because importance may depend on trial type, respondents rated each attribute for efficacy trials (testing an intervention in ideal circumstances) and effectiveness trials (testing an intervention in "real world" circumstances). We calculated the attribute rating means and standard deviations, and used content analysis to characterize open-ended responses. The second questionnaire for resident family members and advocates included open-ended questions about nursing home research, and factors influencing willingness to participate. RESULTS: The attributes rated as most essential for conducting efficacy and effectiveness trials in nursing homes are research team attributes, that is, that researchers recognize regulatory constraints; understand and adapt to nursing home workflow; and work collaboratively with nursing home leaders to identify priorities. Resident and facility diversity emerged as essential for effectiveness trials; important dimensions included resident race, ethnicity and income, as well as nursing home urban/rural location, quality ratings, geography, staffing ratios, size, and profit status. Caregivers and resident advocates stressed the importance of communication among participants, researchers, and nursing home leadership and staff at all stages of a trial. CONCLUSION: Developing a robust U.S. clinical research enterprise capable of efficiently mounting future clinical trials in nursing homes will require a reimagining of the relationships that exist between researchers, facilities, nursing home leaders, and residents, with a research infrastructure specifically focused on supporting and fostering these connections.

Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Mobile Technology Care Coordination of Long-Term Services and Support: Cluster Randomized Clinical Trial.

The purpose of the study was to assess whether the effects of a mobile predictive intervention used by Service Coordinators (SCs) reduce hospital utilization in a Medicaid Long-Term Services and Supports (LTSS) population in Baltimore city during a 5-month intervention. SC participants (n = 11) were recruited to treatment or control groups. LTSS clients (n = 420) followed their SC randomization assignment. Utilization data were obtained from the Maryland Chesapeake Regional Information System for our Patients (CRISP) Health Information Exchange (HIE) system and linked to service coordination records. Study groups were similar in age, gender, race, and years receiving LTSS. SCs' satisfaction with use of the mobile tool was surveyed. SC perceptions were neutral (mean scores ranged from 2.3 to 3.3 on a 5-point scale). No significant differences between groups were observed for all utilization metrics. The mobile technology software system used in this study did not improve health care utilization for a LTSS population needing ongoing clinical and social services coordinated care.

Neighborhood Influences on Physical Activity Among Low-Income African American Adults With Type 2 Diabetes Mellitus.

PURPOSE: The purpose of the study was to explore the influences of the neighborhood environment on physical activity (PA) among people living with type 2 diabetes mellitus (T2DM) in a community with limited resources. METHODS: Participants were adults with T2DM and their family members or friends who help in the management of T2DM and who were living in a low-income African American (AA) community. Health care providers working in the neighborhood were also included. Using an emergent design, qualitative data were collected through 7 focus group discussions (N = 63) and 13 in-depth interviews. Verbatim transcriptions were analyzed via thematic coding to explore contextual factors that limit PA and meaning around neighborhood features that promote or discourage PA. RESULTS: Levels of PA were strongly limited by neighborhood insecurity and a lack of recreational facilities in the neighborhood. People with T2DM and physical/mobility disabilities were more affected by the neighborhood environment than those without disabilities, particularly due to perceived safety concerns and social stigma. Despite socioeconomic inequalities within neighborhoods, participants showed resilience and made efforts to overcome social-environmental barriers to PA, applied various coping strategies, and received social support. CONCLUSIONS: Results suggested that in an underserved neighborhood, individual barriers to physical activity were amplified by neighborhood-level factors such as crime, especially among individuals who have T2DM and disabilities. Socioeconomic inequalities should be addressed further to improve management of T2DM and its complications.

A Survey of Academic Intensivists' Use of Neuromuscular Blockade in Subjects With ARDS.

BACKGROUND: Our Cooling to Help Injured Lungs (CHILL) trial of therapeutic hypothermia in ARDS includes neuromuscular blockade (NMB) as an inclusion criterion to avoid shivering. NMB has been used to facilitate mechanical ventilation in ARDS and was shown to reduce mortality in the ACURASYS trial. To assess the feasibility of a multi-center CHILL trial, we conducted a survey of academic intensivists about their NMB use in patients with ARDS. METHODS: We distributed via email a 16-question survey about NMB use in patients with ARDS including frequency, indications, and dosing strategy. RESULTS: 212 (24.3%) of 871 respondents completed the survey: 94.7% were board-certified in internal medicine, 88% in pulmonary and critical care; 90.3% practiced in academic medical centers, with 87% working in medical ICUs; 96.6% of respondents who treat ARDS use NMB, and 39.7% use NMB in ≥ 50% of these patients. Of 4 listed indications for initiating NMB in ARDS, allowing adherence with lung-protective ventilator strategies and patient-ventilator synchrony were cited as the most important reasons, followed by the results of the ACURASYS trial and facilitating prone positioning. CONCLUSIONS: We conclude that NMB is frequently used by academic intensivists to facilitate mechanical ventilation in patients with moderate to severe ARDS.

Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.

INTRODUCTION: Limitations in inflammatory bowel disease (IBD) care necessitate greater patient activation and self-efficacy, measures associated with positive health outcomes. METHODS: We assessed change in patient activation and general self-efficacy from baseline to 12 months through our TELEmedicine for IBD trial, a multicenter, randomized controlled trial consisting of a web-based monitoring system that interacts with participants via text messaging. A total of 222 adults with IBD who had experienced an IBD flare within 2 years prior to the trial were randomized into either a control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W). RESULTS: Changes in self-efficacy scores were not significantly different between control and experimental groups. Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03). CONCLUSIONS: Use of remote monitoring did not improve self-efficacy or patient activation compared to routine care.

Correction to: Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.

This manuscript is a secondary analysis of a large multicenter randomized controlled trial. The primary study is Cross RK et al., A Randomized Controlled Trial of TELEmedicine for patients with Inflammatory Bowel Disease (TELE-IBD). Am J Gastroenterol, 2019 Mar.

Digital assessment of falls risk, frailty, and mobility impairment using wearable sensors.

Falls are among the most frequent and costly population health issues, costing $50bn each year in the US. In current clinical practice, falls (and associated fall risk) are often self-reported after the "first fall", delaying primary prevention of falls and development of targeted fall prevention interventions. Current methods for assessing falls risk can be subjective, inaccurate, have low inter-rater reliability, and do not address factors contributing to falls (poor balance, gait speed, transfers, turning). 8521 participants (72.7 ± 12.0 years, 5392 female) from six countries were assessed using a digital falls risk assessment protocol. Data consisted of wearable sensor data captured during the Timed Up and Go (TUG) test along with self-reported questionnaire data on falls risk factors, applied to previously trained and validated classifier models. We found that 25.8% of patients reported a fall in the previous 12 months, of the 74.6% of participants that had not reported a fall, 21.5% were found to have a high predicted risk of falls. Overall 26.2% of patients were predicted to be at high risk of falls. 29.8% of participants were found to have slow walking speed, while 19.8% had high gait variability and 17.5% had problems with transfers. We report an observational study of results obtained from a novel digital fall risk assessment protocol. This protocol is intended to support the early identification of older adults at risk of falls and inform the creation of appropriate personalized interventions to prevent falls. A population-based approach to management of falls using objective measures of falls risk and mobility impairment, may help reduce unnecessary outpatient and emergency department utilization by improving risk prediction and stratification, driving more patients towards clinical and community-based falls prevention activities.

Mobile Support for Older Adults and Their Caregivers: Dyad Usability Study.

BACKGROUND: Evaluation of digital health applications to support older adults' independence and family caregiving is needed. Digital health is increasingly providing opportunities for older adults and their family caregivers to educate, engage, and share health information across digital platforms. Few apps have documented evidence of usability by older adults and their caregivers. OBJECTIVE: The objective of this study was to determine the usability of a mobile app in a community-based older adult population aged ≥65 years. The app was designed to improve engagement of the patient-informal caregiver team. METHODS: This observational usability study was conducted in participants' homes and independent living facilities in Baltimore, Maryland. Community-dwelling older adults aged ≥65 years and their caregivers enrolled as a dyad (n=24, 12 dyads). The usability evaluation was a mobile and Web-based app that allowed older adult users to record social and health information and share this information with their caregivers. The older adult-caregiver dyad downloaded the app to a smart phone or accessed the Web version, participated in training and onboarding, and used the app for a 1-month period. Participants responded to weekly surveys sent by app push notifications and to the usability and satisfaction surveys at the end of the study. Participant satisfaction and usability were assessed using the Modified Mobile Application Rating Scale (M-MARS) and the System Usability Scale (SUS). RESULTS: The final sample comprised 16 people (8 dyads). Responses to the M-MARS were comparable between older adults and caregiver respondents in terms of engagement and functionality. Caregivers rated aesthetics slightly higher (mean 3.7) than older adult participants did (mean 3.3). Although most responses to the SUS were around the mean (2.3-3.4), older adults and their caregivers differed with regard to integration of app features (mean 3.7 vs 2.8) and the need to learn more before using the app (mean 2.3 vs 3.1). CONCLUSIONS: Technology ownership and use among older adults and caregivers was high. Usability and engagement of the mobile app was average. Additional training is recommended for older adults and their caregivers, including that on targeted behaviors for digital health record keeping.

Community-Driven Priorities in Smartphone Application Development: Leveraging Social Networks to Self-Manage Type 2 Diabetes in a Low-Income African American Neighborhood.

Social networks have the potential to enhance Type 2 Diabetes Mellitus (T2DM) self-management. We used qualitative methods to study if and how mobile application (app) functions that mobilize social resources to improve T2DM management would be desired in a low-income African American community. Data were collected through community discussions and in-depth interviews with 78 participants in 2016-2018. Participants included individuals with self-reported pre-diabetes, T2DM, close family members or friends of a T2DM patient, and healthcare providers. Open-ended questions solicited information about challenges with T2DM management and gathered ideas on features of a mobile app that could address them. Data were transcribed and thematically coded by two coders using Atlas-ti. Regarding types of app functions, main themes included: (1) the importance of having support in diabetes self-care; (2) using informal networks to help to each other; and (3) monitoring one another through an app. Suggested app features included reminders for and transportation to medical visits, sharing information and exercise companionship, and providing opportunities for monitoring by friends/family members, especially in case of emergencies. Participants viewed an app as a potential vehicle for reinforcing accomplishments in T2DM self-management. Future research should implement and test an app with these features in this or similar communities.

The Forgotten Middle: Many Middle-Income Seniors Will Have Insufficient Resources For Housing And Health Care.

As people age and require more assistance with daily living and health needs, a range of housing and care options is available. Over the past four decades the market for seniors housing and care-including assisted living and independent living communities-has greatly expanded to accommodate people with more complex needs. These settings provide housing in a community environment that often includes personal care assistance services. Unfortunately, these settings are often out of the financial reach of many of this country's eight million middle-income seniors (those ages seventy-five and older). The private seniors housing industry has generally focused on higher-income people instead. We project that by 2029 there will be 14.4 million middle-income seniors, 60 percent of whom will have mobility limitations and 20 percent of whom will have high health care and functional needs. While many of these seniors will likely need the level of care provided in seniors housing, we project that 54 percent of seniors will not have sufficient financial resources to pay for it. This gap suggests a role for public policy and the private sector in meeting future long-term care and housing needs for middle-income seniors.

A Randomized Controlled Trial of TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD).

INTRODUCTION: Telemedicine has shown promise in inflammatory bowel disease (IBD). The objective of this study was to compare disease activity and quality of life (QoL) in a 1-year randomized trial of IBD patients receiving telemedicine vs. standard care. METHODS: Patients with worsening symptoms in the prior 2 years were eligible for randomization to telemedicine (monitoring via texts EOW or weekly) or standard care. The primary outcomes were the differences in change in disease activity and QoL between the groups; change in healthcare utilization among groups was a secondary aim. RESULTS: 348 participants were enrolled (117 control group, 115 TELE-IBD EOW, and 116 TELE-IBD weekly). 259 (74.4%) completed the study. Age was 38.9 ± 12.3 years, 56.6% were women, 91.9% were Caucasian, 67.9% had Crohn's disease (CD) and 42.5% had active disease at baseline. In CD, all groups experienced a decrease in disease activity (control -5.2 ± 5.0 to 3.7 ± 3.6, TELE-IBD EOW 4.7 ± 4.1 to 4.2 ± 3.9, and TELE-IBD weekly 4.2 ± 4.2 to 3.2 ± 3.4, p < 0.0001 for each of the groups) In UC, only controls had a significant decrease in disease activity (control 2.9 ± 3.1 to 1.4 ± 1.4, p = 0.01, TELE-IBD EOW 2.7 ± 3.1 to 1.7 ± 1.9, p = 0.35, and TELE-IBD Weekly 2.5 ± 2.5 to 2.0 ± 1.8, p = 0.31). QoL increased in all groups; the increase was significant only in TELE-IBD EOW (control 168.1 ± 34.0 to 179.3 ± 28.2, p = 0.06, TELE-IBD EOW 172.3 ± 33.1 to 181.5 ± 28.2, p = 0.03, and TELE-IBD Weekly 172.3 ± 34.5 to 179.2 ± 32.8, p = 0.10). Unadjusted and adjusted changes in disease activity and QoL were not significantly different among groups. Healthcare utilization increased in all groups. TELE-IBD weekly were less likely to have IBD-related hospitalizations and more likely to have non-invasive diagnostic tests and electronic encounters compared to controls; both TELE-IBD groups had decreased non-IBD related hospitalizations and increased telephone calls compared to controls. DISCUSSION: Disease activity and QoL, although improved in all participants, were not improved further through use of the TELE-IBD system. TELE-IBD participants experienced a decrease in hospitalizations with an associated increase in non-invasive diagnostic tests, telephone calls and electronic encounters. Research is needed to determine if TELE-IBD can be improved through patient engagement and whether it can decrease healthcare utilization by replacing standard care.

An mHealth Diabetes Intervention for Glucose Control: Health Care Utilization Analysis.

BACKGROUND: Type 2 diabetes (T2D) is a major chronic condition requiring management through lifestyle changes and recommended health service visits. Mobile health (mHealth) is a promising tool to encourage self-management, but few studies have investigated the impact of mHealth on health care utilization. OBJECTIVE: The objective of this analysis was to determine the change in 2-year health service utilization and whether utilization explained a 1.9% absolute decrease in glycated hemoglobin (HbA1c) over 1-year in the Mobile Diabetes Intervention Study (MDIS). METHODS: We used commercial claims data from 2006 to 2010 linked to enrolled patients' medical chart data in 26 primary care practices in Maryland, USA. Secondary claims data analyses were available for 56% (92/163) of participants. In the primary MDIS study, physician practices were recruited and randomized to usual care and 1 of 3 increasingly complex interventions. Patients followed physician randomization assignment. The main variables in the analysis included health service utilization by type of service and change in HbA1c. The claims data was aggregated into 12 categories of utilization to assess change in 2-year health service usage, comparing rates of usage pre- and posttrial. We also examined whether utilization explained the 1.9% decrease in HbA1c over 1 year in the MDIS cluster randomized clinical trial. RESULTS: A significant group by time effect was observed in physician office visits, general practitioner visits, other outpatient services, prescription medications, and podiatrist visits. Physician office visits (P=.01) and general practitioner visits (P=.02) both decreased for all intervention groups during the study period, whereas prescription claims (P<.001) increased. The frequency of other outpatient services (P=.001) and podiatrist visits (P=.04) decreased for the control group and least complex intervention group but increased for the 2 most complex intervention groups. No significant effects of utilization were observed to explain the clinically significant change in HbA1c. CONCLUSIONS: Claims data analyses identified patterns of utilization relevant to mHealth interventions. Findings may encourage patients and health providers to discuss the utilization of treatment-recommended services, lab tests, and prescribed medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by Webcite at http://www.webcitation.org/72XgTaxIj).

Inflammatory Bowel Disease Telemedicine Clinical Trial: Impact of Educational Text Messages on Disease-Specific Knowledge Over 1 Year.

Background: Effective treatments are available for patients with inflammatory bowel disease (IBD); however, suboptimal outcomes occur and are often linked to patients' limited disease knowledge. The aim of this analysis was to determine if delivery of educational messages through a telemedicine system improves IBD knowledge. Methods: TELEmedicine for Patients with IBD (TELE-IBD) was a randomized controlled trial with visits at baseline, 6 months, and 12 months; patient knowledge was a secondary aim of the study. Patients were randomized to receive TELE-IBD every other week (EOW), weekly (TELE-IBD W), or standard of care. Knowledge was assessed at each visit with the Crohn's and Colitis Knowledge (CCKNOW) survey. The primary outcome was change in CCKNOW score over 1 year compared between the TELE-IBD and control groups. Results: This analysis included 219 participants. Participants in the TELE-IBD arms had a greater improvement in CCKNOW score compared with standard care (TELE-IBD EOW +2.4 vs standard care +1.8, P = 0.03; TELE-IBD W +2.0 vs standard care +1.8, P = 0.35). Participants with lower baseline CCKNOW scores had a greater change in their score over time (P < 0.01). However, after adjusting for race, site, and baseline knowledge, there was no difference in CCKNOW score change between the control and telemedicine arms. Conclusions: Telemedicine improves IBD-specific knowledge through text messaging, although the improvement is not additive with greater frequency of text messages. However, after adjustment for confounding variables, telemedicine is not superior to education given through standard visits at referral centers. Further research is needed to determine if revised systems with different modes of delivery and/or frequency of messages improve disease knowledge.

Multiple chronic condition profiles and survival among oldest-old male patients with hip fracture.

To improve understanding of survival among very elderly male patients with surgically repaired hip fractures, this study applied classification techniques to multiple chronic conditions (MCC) then modeled survival by latent class. Veterans Health Administration (VHA)'s electronic medical records on male inpatients age 85-100 years (n=896) with hip fracture diagnosis and repair were used. MCC defined by Charlson and Elixhauser disorders, medications, demographic covariates, and 5 years follow-up survival were included. Latent Class Analysis (LCA) identified three classes based on patterns of MCC, medications, and demographic covariates: Low-comorbidity (16%), High-longevity (55%), and High-comorbidity (29%). Overall, survival censored at 5 years post-op averaged 717days. The Low-comorbidity group was more likely to be Hispanic, less disabled per VHA determination of eligibility for care, with less risk of postoperative emergency department (ED) visit, and taking no prescription medications. The High-longevity group had longer survival. The High-comorbidity group had more MCC, more prescription medications and shorter survival than the other two groups. Accelerated failure time (AFT) modeled associations between MCC and 5-year survival by class. In AFT models, fewer days until first postoperative ED visit was significantly associated with survival across the three classes. About one in male hip fractured veteran patients over the age of 85 had high levels of MCC and ED use and experienced shorter survival. Hip fracture patients with MCC may merit enhanced post-discharge management. Close investigation targeted to MCC and hip fractures is needed to optimize clinical practices for oldest-old patients in community healthcare systems as well as VHA.

The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial.

BACKGROUND: Diabetes is a complex, demanding disease that requires the constant attention of patients. The burden of self-management, including different medication regimens, routine self-care activities, and provider visits, has an impact on patients' emotional well-being. Diabetes distress and depression are two important components of emotional well-being that may negatively affect diabetes outcomes. OBJECTIVE: The aim was to determine the impact of the 1-year Mobile Diabetes Intervention Study cluster randomized clinical trial on emotional well-being measured by diabetes distress and depression among adults with type 2 diabetes (T2D). METHODS: A total of 163 adults with not-well-managed T2D were enrolled from community primary care practices. Primary care practices were cluster randomized into either a usual care control group or intervention group. Intervention participants were given a mobile phone with coaching software including a Web portal to communicate with providers. A priori established secondary outcomes included distress measured by the Diabetes Distress Scale (DDS), with subscales measuring emotional burden, interpersonal distress, physician-related distress, and regimen-related distress, as well as depression measured by the Patient Health Questionnaire (PHQ-9). Linear mixed models were used to calculate the effect of the intervention on diabetes distress levels over time, both overall and separately by sex, and to determine if the intervention affected distress or depression. The impact of total DDS on changes in HbA1c was also studied. RESULTS: There were no significant treatment group effects for DDS total (baseline: P=.07; differences over time: P=.38) or for depression (P=.06 over time). Significant declines in total DDS were observed over the 12-month intervention period (P=.01). Regimen-related distress significantly decreased for all study participants (P<.001), but no significant change over time was observed for emotional burden (P=.83), interpersonal distress (P=.64), or physician-related distress (P=.73). Women in both the usual care and intervention groups were more likely to have higher overall DDS, emotional burden, physician-related distress, and regimen-related distress, but not interpersonal distress. Women also reported higher baseline depression compared to men (P=.006). Overall, depression decreased over the treatment period (P=.007), but remained unaffected by group assignment (P=.06) or by sex (P=.97). Diabetes distress had no effect on the change in HbA1c (P=.91) over the treatment period. CONCLUSIONS: Although we found no definitive overall or sex-specific effect of the intervention on diabetes distress or depression, this study makes an important contribution to the understanding of mobile health interventions and the impact on emotional health. Our study verified previous work that although diabetes distress and depression are highly correlated, these measures are not evaluating the same construct. Design of future mobile technology provides an opportunity to personalize, contextualize, and intervene in the emotional well-being of persons with diabetes. TRIAL REGISTRATION: Clinicaltrials.gov NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by WebCite at http://www.webcitation.org/6vVgRCLAF).