Heart failure (HF) causes significant economic and humanistic burden for patients and their families, especially those with a low income, partly due to high hospital readmission rates. Optimal self-care is considered an important nonpharmacological aspect of HF management that can improve health outcomes. Emerging evidence suggests that self-management assisted by smartphone apps may reduce rehospitalization rates and improve the quality of life of patients. We developed a virtual human-assisted, patient-centered mobile health app (iHeartU) for patients with HF to enhance their engagement in self-management and improve their communication with health care providers and family caregivers. iHeartU may help patients with HF in self-management to reduce the technical knowledge and usability barrier while maintaining a low cost and natural, effective social interaction with the user. With a standardized systematic usability assessment, this study had two objectives: (1) to determine the obstacles to effective and efficient use of iHeartU in patients with HF and (2) to evaluate of HF patients' adoption, satisfaction, and engagement with regard to the of iHeartU app. The basic methodology to develop iHeartU systems consists of a user-centric design, development, and mixed methods formative evaluation. The iterative design and evaluation are based on the guidelines of the American College of Cardiology Foundation and American Heart Association for the management of heart failure and the validated "Information, Motivation, and Behavioral skills" behavior change model. Our hypothesis is that this method of a user-centric design will generate a more usable, useful, and easy-to-use mobile health system for patients, caregivers, and practitioners. The prototype of iHeartU has been developed. It is currently undergoing usability testing. As of September 2018, the first round of usability testing data have been collected. The final data collection and analysis are expected to be completed by the end of 2019. The main contribution of this project is the development of a patient-centered self-management system, which may support HF patients' self-care at home and aid in the communication between patients and their health care providers in a more effective and efficient way. Widely available mobile phones serve as care coordination and "no-cost" continuum of care. For low-income patients with HF, a mobile self-management tool will expand their accessibility to care and reduce the cost incurred due to emergency visits or readmissions. The user-centered design will improve the level of engagement of patients and ultimately lead to better health outcomes. Developing and testing a novel mobile system for patients with HF that incorporates chronic disease management is critical for advancing research and clinical practice of care for them. This research fills in the gap in user-centric design and lays the groundwork for a large-scale population study in the next phase. DERR1-10.2196/13502.

To investigate the feasibility of delivering a low-dose mindfulness-based stress reduction (MBSR) intervention among prediabetes/diabetes patients in a clinical setting. This was a single-arm, mixed methods, feasibility study among prediabetes/diabetes patients at a healthcare center in United States. The low-dose MBSR intervention was delivered in group format over 4 waves and each wave comprised 8-10 h of 8 sessions over 6-8 weeks. We evaluated recruitment, adherence, and attrition rates, participants' satisfaction, motivation and barriers of low-dose MBSR. Psychological, behavioral, and physical measures were compared between pre- and post-intervention. We enrolled 19 participants of 34 eligible individuals with a recruitment rate of 55.9%. Among 19 enrolled participants, 4 dropped out after baseline data collection and did not attend any session and 1 attended one session but did not finish post-intervention data collection, resulting in an attrition rate of 26.3%. Among 15 participants attending at least one session, 46.7% attended all sessions and 80.0% attended at least 5 sessions. Qualitative analysis among 11 participants indicated that 90.9% had positive overall experience with the intervention. Compared to pre-intervention, there was a significant reduction in depression score (mean reduction = 5.04, SD = 7.66, p = 0.02), a higher proportion of engaging in flexibility exercises (42.86% vs. 85.71%, p = 0.01) and a lower level of glycosylated hemoglobin (HbA1c) (mean reduction = 1.43%, SD = 2.54%, p = 0.03) at post-intervention. Delivering a low-dose MBSR intervention to prediabetes/diabetes patients in a primary care setting is feasible. Future studies with randomized controlled design and larger sample are warranted.

We examined the impact of a group-based self-empowerment intervention among diabetes patients, which uses multidisciplinary education, collaborative learning, peer support, and development of diabetes-specific social capital to improve glycemic control and weight management. Thirty-five patients who had primary care established at the Prisma Health Upstate, Internal Medicine Resident clinic and held the diagnosis of diabetes for longer than one year were recruited for our single-arm pilot intervention. Each group intervention session involved one to two internal medicine resident physician facilitators, a clinical diabetic educator, and 5–10 patients. Each session had a framework facilitated by the resident, with most of the discussion being patient-led, aiming to provide a collaborative learning environment and create a support group atmosphere to encourage self-empowerment. Patients’ hemoglobin A1c level and body mass index (BMI) before the intervention and 3 to 6 months after completion were collected from the laboratory results obtained in the participants’ routine clinic visits. All graduates from this three-week intervention were invited to attend monthly maintenance sessions, and we tracked the HgbA1c measures of 29 JUMP graduates one year after the intervention, even though 13 of the 29 chose not to participate in the monthly maintenance sessions. The pre-intervention HgbA1c level averaged 8.84%, whereas the post-intervention HgbA1c level averaged 7.81%. A paired t test showed that this pre–post difference of 1.03 percentage points was statistically significant (p = 0.0007). For BMI, there was an average decline of 0.78 from the pre-intervention mean value of 40.56 to the post-intervention mean value of 39.78 (p = 0.03). Among the 29 participants who agreed to participate in our follow-up measure of their HgbA1c status one year after the intervention, a paired t test showed that there was no significant difference between the post-JUMP measure and the follow-up measure (p = 0.808). There was no statistically significant difference between the HgbA1c level of those participating in the maintenance program and that of those not participating (post-intervention t test of between-group difference: p = 0.271; follow-up t test of between-group difference: p = 0.457). Our single-arm, pilot study of the three-week group intervention of self-empowerment shows promising results in glycemic control and weight loss. The short duration and small number of sessions expected could make it more feasible for implementation and dissemination as compared with popular intervention protocols that require much longer periods of attendance, if the effectiveness of this patient group-based self-empowerment approach can be further established by randomized controlled studies in the future.

Background: Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy. Objective: This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression. Methods: To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes. Results: This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019. Conclusions: This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT’s efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs. Trial Registration: ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719 International Registered Report Identifier (IRRID): DERR1-10.2196/53966

BACKGROUND Depression poses a major threat to public health with an increasing prevalence in the United States. Mindfulness-based interventions, such as mindfulness-based cognitive therapy (MBCT), are effective methods for managing depression symptoms and may help fortify existing efforts to address the current disease burden. The in-person group format of MBCT, however, incurs barriers to care such as expenses, childcare needs, and transportation issues. Alternate delivery modalities such as MBCT delivered via the web can be investigated for their capacity to overcome these barriers and still reduce symptoms of depression with adequate feasibility and efficacy. OBJECTIVE This study protocol aims to examine the feasibility and efficacy of MBCT delivered via the web for the treatment of depression. METHODS To attain study aims, 2 phases will be implemented using a waitlist control design. A total of 128 eligible participants will be randomized into either an 8-week MBCT intervention group plus treatment as usual (MBCT + TAU; group 1) or an 8-week waitlist control group (group 2). In phase I (8 weeks), group 1 will complete the intervention and group 2 will proceed with TAU. In phase II (8 weeks), group 2 will complete the intervention and group 1 will continue with TAU until reaching an 8-week follow-up. TAU may consist of receiving psychotherapy, pharmacotherapy, or combined treatment. Data collection will be completed at baseline, 8 weeks (postintervention for group 1 and preintervention for group 2), and 16 weeks (follow-up for group 1, postintervention for group 2). The primary outcomes will include (1) current, residual, or chronic depression symptoms and (2) psychiatric distress. Secondary outcomes will include perceived stress and facets of mindfulness. The feasibility will be measured by assessing protocol adherence, retention, attendance, and engagement. Finally, the extent of mindfulness self-practice and executive functioning skills will be assessed as mediators of intervention outcomes. RESULTS This study began screening and recruitment in December 2022. Data collection from the first cohort occurred in January 2023. By November 2023, a total of 30 participants were enrolled out of 224 who received screening. Data analysis began in February 2024, with an approximate publication of results by August 2024. Institutional review board approval took place on September 11, 2019. CONCLUSIONS This trial will contribute to examining mindfulness-based interventions, delivered via the web, for improving current, residual, or chronic depression symptoms. It will (1) address the feasibility of MBCT delivered via the web; (2) contribute evidence regarding MBCT’s efficacy in reducing depression symptoms and psychiatric distress; and (3) assess the impact of MBCT on several important secondary outcomes. Findings from this study will develop the understanding of the causal pathways between MBCT delivered via the web and depression symptoms further, elucidating the potential for future larger-scale designs. CLINICALTRIAL ClinicalTrials.gov NCT05347719; https://www.clinicaltrials.gov/ct2/show/NCT05347719 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/53966

BACKGROUND Heart failure (HF) causes significant economic and humanistic burden for patients and their families, especially those with a low income, partly due to high hospital readmission rates. Optimal self-care is considered an important nonpharmacological aspect of HF management that can improve health outcomes. Emerging evidence suggests that self-management assisted by smartphone apps may reduce rehospitalization rates and improve the quality of life of patients. We developed a virtual human–assisted, patient-centered mobile health app (iHeartU) for patients with HF to enhance their engagement in self-management and improve their communication with health care providers and family caregivers. iHeartU may help patients with HF in self-management to reduce the technical knowledge and usability barrier while maintaining a low cost and natural, effective social interaction with the user. OBJECTIVE With a standardized systematic usability assessment, this study had two objectives: (1) to determine the obstacles to effective and efficient use of iHeartU in patients with HF and (2) to evaluate of HF patients’ adoption, satisfaction, and engagement with regard to the of iHeartU app. METHODS The basic methodology to develop iHeartU systems consists of a user-centric design, development, and mixed methods formative evaluation. The iterative design and evaluation are based on the guidelines of the American College of Cardiology Foundation and American Heart Association for the management of heart failure and the validated “Information, Motivation, and Behavioral skills” behavior change model. Our hypothesis is that this method of a user-centric design will generate a more usable, useful, and easy-to-use mobile health system for patients, caregivers, and practitioners. RESULTS The prototype of iHeartU has been developed. It is currently undergoing usability testing. As of September 2018, the first round of usability testing data have been collected. The final data collection and analysis are expected to be completed by the end of 2019. CONCLUSIONS The main contribution of this project is the development of a patient-centered self-management system, which may support HF patients’ self-care at home and aid in the communication between patients and their health care providers in a more effective and efficient way. Widely available mobile phones serve as care coordination and “no-cost” continuum of care. For low-income patients with HF, a mobile self-management tool will expand their accessibility to care and reduce the cost incurred due to emergency visits or readmissions. The user-centered design will improve the level of engagement of patients and ultimately lead to better health outcomes. Developing and testing a novel mobile system for patients with HF that incorporates chronic disease management is critical for advancing research and clinical practice of care for them. This research fills in the gap in user-centric design and lays the groundwork for a large-scale population study in the next phase. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13502