Opening the Black Box of an mHealth Patient-Reported Outcome Tool for Diabetes Self-Management: Interview Study Among Patients With Type 2 Diabetes.

BACKGROUND: Mobile health (mHealth) tools are used to collect data on patient-reported outcomes (PROs) and facilitate the assessment of patients' self-management behaviors outside the clinic environment. Despite the high availability of mHealth diabetes tools, there is a lack of understanding regarding the underlying reasons why these mHealth PRO tools succeed or fail in terms of changing patients' self-management behaviors. OBJECTIVE: This study aims to identify the factors that drive engagement with an mHealth PRO tool and facilitate patients' adoption of self-management behaviors, as well as elicit suggestions for improvement. METHODS: This qualitative study was conducted within the context of a randomized controlled trial designed to evaluate the efficacy of an mHealth PRO tool (known as i-Matter) versus usual care regarding reduction in glycated hemoglobin (HbA1c) levels and adherence to self-management behaviors at 12 months among patients with uncontrolled type 2 diabetes. Patients randomized to i-Matter participated in semistructured interviews about their experiences at the 3-, 6-, 9-, and 12-month study visits. A qualitative analysis of the interviews was conducted by 2 experienced qualitative researchers using conventional qualitative content analysis. RESULTS: The sample comprised 71 patients, of whom 67 (94%) completed at least one interview (n=48, 72% female patients; n=25, 37% identified as African American or Black; mean age 56.65 [SD 9.79] years). We identified 4 overarching themes and 6 subthemes. Theme 1 showed that the patients' reasons for engagement with i-Matter were multifactorial. Patients were driven by internal motivating factors that bolstered their engagement and helped them feel accountable for their diabetes (subtheme 1) and external motivating factors that helped to serve as reminders to be consistent with their self-management behaviors (subtheme 2). Theme 2 revealed that the use of i-Matter changed patients' attitudes toward their disease and their health behaviors in 2 ways: patients developed more positive attitudes about their condition and their ability to effectively self-manage it (subtheme 3), and they also developed a better awareness of their current behaviors, which motivated them to adopt healthier lifestyle behaviors (subtheme 4). Theme 3 showed that patients felt more committed to their health as a result of using i-Matter. Theme 4 highlighted the limitations of i-Matter, which included its technical design (subtheme 5) and the need for more resources to support the PRO data collected and shared through the tool (subtheme 6). CONCLUSIONS: This study isolated internal and external factors that prompted patients to change their views about their diabetes, become more engaged with the intervention and their health, and adopt healthy behaviors. These behavioral mechanisms provide important insights to drive future development of mHealth interventions that could lead to sustained behavior change.

Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial.

Depression is associated with adverse outcomes in epilepsy but is undertreated in this population. Project UPLIFT, a telephone-based depression self-management program, was developed for adults with epilepsy and has been shown to reduce depressive symptoms in English-speaking patients. There remains an unmet need for accessible mental health programs for Hispanic adults with epilepsy. The purpose of this study was to evaluate the feasibility, acceptability, and effects on depressive symptoms of a culturally adapted version of UPLIFT for the Hispanic community. Hispanic patients with elevated depressive symptoms (n = 72) were enrolled from epilepsy clinics in New York City and randomized to UPLIFT or usual care. UPLIFT was delivered in English or Spanish to small groups in eight weekly telephone sessions. Feasibility was assessed by recruitment, retention, and adherence rates and acceptability was assessed by self-reported satisfaction with the intervention. Depressive symptoms (PHQ-9 scores) were compared between study arms over 12 months. The mean age was 43.3±11.3, 71% of participants were female and 67% were primary Spanish speakers. Recruitment (76% consent rate) and retention rates (86-93%) were high. UPLIFT participants completed a median of six out of eight sessions and satisfaction ratings were high, but rates of long-term practice were low. Rates of clinically significant depressive symptoms (PHQ-9 ≥5) were lower in UPLIFT versus usual care throughout follow-up (63% vs. 72%, 8 weeks; 40% vs. 70%, 6 months; 47% vs. 70%, 12 months). Multivariable-adjusted regressions demonstrated statistically significant differences at 6 months (OR = 0.24, 95% CI, 0.06-0.93), which were slightly reduced at 12 months (OR = 0.30, 95% CI, 0.08-1.16). Results suggest that UPLIFT is feasible and acceptable among Hispanic adults with epilepsy and demonstrate promising effects on depressive symptoms. Larger trials in geographically diverse samples are warranted.

Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices.

BACKGROUND: Poor adherence to antihypertensive medications is a significant contributor to the racial gap in rates of blood pressure (BP) control among Latino adults, as compared to Black and White adults. While multi-level interventions (e.g., those aiming to influence practice, providers, and patients) have been efficacious in improving medication adherence in underserved patients with uncontrolled hypertension, the translation of these interventions into routine practice within "real world" safety-net primary care settings has been inadequate and slow. This study will fill this evidence-to-practice gap by evaluating the effectiveness of practice facilitation (PF) as a practical and tailored strategy for implementing Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA), a multi-level approach to improving medication adherence and BP control in 10 safety-net practices in New York that serve Latino patients. METHODS AND DESIGN: We will conduct this study in two phases: (1) a pre-implementation phase where we will refine the PF strategy, informed by the Consolidated Framework for Implementation Research, to facilitate the implementation of ALTA into routine care at the practices; and (2) an implementation phase during which we will evaluate, in a stepped-wedge cluster randomized controlled trial, the effect of the PF strategy on ALTA implementation fidelity (primary outcome), as well as on clinical outcomes (secondary outcomes) at 12 months. Implementation fidelity will be assessed using a mixed methods approach based on the five core dimensions outlined by Proctor's Implementation Outcomes Framework. Clinical outcome measures include BP control (defined as BP< 130/80 mmHg) and medication adherence (assessed using the proportion of days covered via pharmacy records). DISCUSSION: The study protocol applies rigorous research methods to identify how implementation strategies such as PF may work to expedite the translation process for implementing evidence-based approaches into routine care at safety-net practices to improve health outcomes in Latino patients with hypertension, who suffer disproportionately from poor BP control. By examining the barriers and facilitators that affect implementation, this study will contribute knowledge that will increase the generalizability of its findings to other safety-net practices and guide effective scale-up across primary care practices nationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT03713515, date of registration: October 19, 2018.

Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study.

BACKGROUND: Patient-reported outcomes (PROs) are increasingly being used in the management of type 2 diabetes (T2D) to integrate data from patients' perspective into clinical care. To date, the majority of PRO tools have lacked patient and provider involvement in their development, thus failing to meet the unique needs of end users, and lack the technical infrastructure to be integrated into the clinic workflow. OBJECTIVE: This study aims to apply a systematic, user-centered design approach to develop i-Matter (investigating a mobile health [mHealth] texting tool for embedding patient-reported data into diabetes management), a theory-driven, mobile PRO system for patients with T2D and their primary care providers. METHODS: i-Matter combines text messaging with dynamic data visualizations that can be integrated into electronic health records (EHRs) and personalized patient reports. To build i-Matter, we conducted semistructured group and individual interviews with patients with T2D and providers, a design thinking workshop to refine initial ideas and design the prototype, and user testing sessions of prototypes using a rapid-cycle design (ie, design-test-modify-retest). RESULTS: Using an iterative user-centered process resulted in the identification of 6 PRO messages that were relevant to patients and providers: medication adherence, dietary behaviors, physical activity, sleep quality, quality of life, and healthy living goals. In user testing, patients recommended improvements to the wording and timing of the PRO text messages to increase clarity and response rates. Patients also recommended including motivational text messages to help sustain engagement with the program. The personalized report was regarded as a key tool for diabetes self-management by patients and providers because it aided in the identification of longitudinal patterns in the PRO data, which increased patient awareness of their need to adopt healthier behaviors. Patients recommended adding individualized tips to the journal on how they can improve their behaviors. Providers preferred having a separate tab built into the EHR that included the personalized report and highlighted key trends in patients' PRO data over the past 3 months. CONCLUSIONS: PRO tools that capture patients' well-being and the behavioral aspects of T2D management are important to patients and providers. A clinical trial will test the efficacy of i-Matter in 282 patients with uncontrolled T2D. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652389; https://clinicaltrials.gov/ct2/show/NCT03652389.

Depression self-management in people with epilepsy: Adapting project UPLIFT for underserved populations.

Data from the 2015 National Health Interview Survey found that the prevalence of active epilepsy has increased to three million adults. Although findings have been mixed, some research indicates that Blacks and Hispanics share a higher burden of epilepsy prevalence compared with non-Hispanic whites. Moreover, depression is a common comorbid condition among people with epilepsy (PWE), affecting up to 55% of the epilepsy population. Widespread use and increased public health impact of evidence-based self-management interventions is critical to reducing disease burden and may require adapting original interventions into more culturally relevant versions for racial and ethnic minority groups. Project UPLIFT provides access to mental health self-management skills training that is distance-delivered, does not interfere with medication management, and has been shown to be effective in reducing depressive symptoms. This paper presents the process of exploring the adaptation of Project UPLIFT for Black and Hispanic PWE and herein suggests that evidence-based interventions can be successfully adapted for new populations or cultural settings through a careful and systematic process. Additional key lessons learned include the importance of community engagement and that language matters. Ultimately, if the adapted Project UPLIFT intervention produces positive outcomes for diverse populations of PWE, it will extend the strategies available to reduce the burden of depression. Implementing evidence-based interventions such as Project UPLIFT is critical to reducing disease burden; however, their delivery may need to be tailored to the needs and culture of the populations of interest.