Perceptions of the Fatigue Experience and a Breathing Awareness Meditation-Integrated mHealth App for Fatigue and Stress in Patients with Sarcoidosis.

Objective: Sarcoidosis-associated fatigue is a debilitating consequence of sarcoidosis, a multi-system inflammatory disease, and may be related to increased stress associated with sarcoidosis. Breathing awareness meditation has potential as an intervention for managing stress and fatigue for sarcoidosis patients (SPs). This project's aim was to obtain feedback from key informants to design and tailor a patient-centered Sarcoidosis Patient Resource and Companion (SPARC) mHealth App developed for SPs to manage fatigue and stress at home using breathing awareness meditation. Methods: We used a mixed-method patient/user-centered design with triangulation to understand SPs experiences of sarcoidosis-associated fatigue and stress (n = 13), and obtain feedback on the SPARC App-prototype integrating breathing awareness meditation from these SPs and health care team members (HCTMs; n = 5). Using deductive content analysis, transcribed interviews were coded for themes and subthemes. Results: We report on findings from qualitative interviews and assessment of SPs' experiences including themes describing fatigue/stress interactions. Themes indicated that SPs find fatigue to be a profoundly difficult experience affecting multiple domains of functioning for which they perceive few effective strategies to cope. SPs and HCTMs shared feedback on the SPARC App-prototype after a test session; it was reported to be user friendly and to have potential for improving fatigue/stress, and key points for tailoring the App to SPs were shared. Conclusion: Sarcoidosis-associated fatigue poses a significant burden for SPs. The SPARC App-prototype with breathing awareness meditation was acceptable and feasible to use and was well-received by SPs and HCTMs. Future iterations of the SPARC App to test the effect of breathing awareness meditation on fatigue will need to incorporate recommendations for tailoring for SPs.

Design and rationale of a pilot randomized clinical trial investigating the use of a mHealth app for sarcoidosis-associated fatigue.

Fatigue is the most reported symptom in patients with sarcoidosis (SPs) and is a significant predictor of decreased quality of life that is strongly associated with stress and negative mood states. Few medications exist for treating fatigue in SPs, and outpatient physical rehabilitation programs are limited by availability and cost. Sarcoidosis in the US predominantly impacts minorities and underserved populations who are of working age and often have limited resources (e.g., financial, transportation, time off work) that may prevent them from attending in-person programs. The use of mobile health (mHealth) is emerging as a viable alternative to provide access to self-management resources to improve quality of life. The Sarcoidosis Patient Assessment and Resource Companion (SPARC) App is a sarcoidosis-specific mHealth App intended to improve fatigue and stress in SPs. It prompts SPs to conduct breathing awareness meditation (BAM) and contains educational modules aimed at improving self-efficacy. Herein we describe the design and methods of a 3-month randomized control trial comparing use of the SPARC App (10-min BAM twice daily) to standard care in 50 SPs with significant fatigue (FAS ≥22). A Fitbit® watch will provide immediate heartrate feedback after BAM sessions to objectively monitor adherence. The primary outcomes are feasibility and usability of the SPARC App (collected monthly). Secondary endpoints include preliminary efficacy at improving fatigue, stress, and quality of life. We expect the SPARC App to be a useable and feasible intervention that has potential to overcome barriers of more traditional in-person programs.

Diurnal Cortisol Slope and Nighttime Blood Pressure: A Study in European Americans and African Americans.

OBJECTIVES: African Americans (AAs) have higher nighttime blood pressure (BP) than European Americans (EAs). Stress has been suggested to play a role in this difference, but the mechanism is not well-understood. Flatter diurnal cortisol slope (DCS) is a well-known biological marker of stress. The objectives of this study were to: 1) examine ethnic differences in DCS; 2) evaluate the association between DCS and nighttime BP; and 3) determine the extent to which ethnic differences in nighttime BP can be explained by ethnic differences in DCS. METHODS: A total of 510 participants (age range: 14-35 years; 49.6% AAs, 54.5% females) provided four salivary cortisol samples at bedtime, wakeup, 30-minutes post-wakeup, and 60-minutes post-wakeup. Additionally, participants wore an ambulatory BP monitor for 24 hours. DCS was calculated as the average of the three morning samples minus the bedtime measurement. RESULTS: After adjustment for age, sex, BMI, and smoking, AAs had blunted DCS (P=.018) and higher nighttime systolic BP (SBP) and diastolic BP (DBP) (Ps<.001) compared with EAs. The DCS was inversely related to nighttime SBP and this relationship did not depend on ethnicity. The ethnic difference of nighttime SBP was significantly attenuated upon addition of DCS to the model. Mediation test showed that 9.5% of ethnic difference in nighttime SBP could be explained by DCS (P=.039). CONCLUSION: This study confirms ethnic differences in DCS and nighttime BP and further demonstrates that the ethnic differences in DCS can, at least partially, explain the ethnic differences found in nighttime BP.

Acceptability of a Mobile-Health Living Kidney Donor Advocacy Program for Black Wait-Listed Patients.

Marked racial disparities exist in rates of living donor kidney transplantation (LDKT). The Living Organ Video Educated Donors (LOVED) program is a distance-based, mobile health program designed to help Black kidney transplant wait-list patients advocate for a living donor. This study reported on the acceptability outcomes to aid in future refinements. Participants were randomized to LOVED (n = 24, mean age = 50.9 SD (9.2) years), male = 50%) and usual care groups (n = 24 (mean age 47.9 SD (10.0), male 50%). Four LOVED groups completed an eight-week intervention that consisted of six online video education modules and eight group video chat sessions led by a Black navigator. Qualitative analysis from post-study focus groups resulted in six themes: (1) video chat sessions provided essential support and encouragement, (2) videos motivated and made participants more knowledgeable, (3) connectivity with tablets was acceptable in most areas, (4) material was culturally sensitive, (5) participation was overall a positive experience and (6) participants were more willing to ask for a kidney now. The video chat sessions were pertinent in participant satisfaction, though technology concerns limited program implementation. Results showed that the LOVED program was acceptable to engage minorities in health behavior changes for living donor advocacy but barriers exist that require future refinement.

A distance-based living donor kidney education program for Black wait-list candidates: A feasibility randomized trial.

Addressing racial disparities in living donor kidney transplants (LDKT) among Black patients warrants innovative programs to improve living donation rates. The Living Organ Video Educated Donors (LOVED) program is a 2-arm, culturally-tailored, distance-based, randomized controlled feasibility trial. The group-based, 8-week program used peer-navigator led video chat sessions and web-app video education for Black kidney waitlisted patients from United States southeastern state. Primary feasibility results for LOVED (n = 24) and usual care (n = 24) arms included LOVED program tolerability (i.e., 95.8% retention), program fidelity (i.e., 78.9% video education adherence and 72.1% video chat adherence). LDKT attitudinal and knowledge results favored the LOVED group where a statistically significant effect was reported over 6-months for willingness to approach strangers (estimate ± SE: -1.0 ± .55, F(1, 45.3) = 7.5, P = .009) and self-efficacy to advocate for a LDKT -.81 ± .31, F(1, 45.9) = 15.2, P < .001. Estimates were improved but not statistically significant for willingness to approach family and friends, LDKT knowledge and concerns for living donors (all P's > .088). Secondary measures at 6 months showed an increase in calls for LOVED compared to usual care (P = .008) though no differences were found for transplant center evaluations or LDKTs. Findings imply that LOVED increased screening calls and attitudes to approach potential donors but feasibility outcomes found program materials require modification to increase adherence.

Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk factor: Protocol of a RCT.

BACKGROUND: Geographical and racial disparities in stroke outcomes are especially prominent in the Southeastern United States, which represents a region more heavily burdened with stroke compared to the rest of the country. While stroke is eminently preventable, particularly via blood pressure control, fewer than one third of patients with a stroke have their blood pressure controlled ≥ 75% of the time, and low consistency of blood pressure control is linked to higher stroke risk. OBJECTIVE: To demonstrate that a mHealth technology-centered, integrated approach can effectively improve sustained blood pressure control among stroke patients (half of whom will be Black). DESIGN: The Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor is a prospective randomized controlled trial, which will include a cohort of 200 patients with a stroke, encountered at two major safety net health care systems in South Carolina. The intervention comprises utilization of a Vaica electronic pill tray & blue-toothed UA-767Plus BT blood pressure device and a dedicated app installed on patients' smart phones for automatic relay of data to a central server. Providers will follow care protocols based on expert consensus practice guidelines to address optimal blood pressure management. STUDY OUTCOMES: Primary outcome is systolic blood pressure at 12-months, which is the major modifiable step to stroke event rate reduction. Secondary endpoints include control of other stroke risk factors, medication adherence, functional status, and quality of life. DISCUSSION: We anticipate that a successful intervention will serve as a scalable model of effective chronic blood pressure management after stroke, to bridge racial and geographic disparities in stroke outcomes in the United States. TRIAL REGISTRATION: ClinicalTrials.gov - NCT03401489.

Decreased heritability and emergence of novel genetic effects on pulse wave velocity from youth to young adulthood.

Increased arterial stiffness measured by pulse wave velocity (PWV) is an important parameter in the assessment of cardiovascular risk. Our previous longitudinal study has demonstrated that carotid-distal PWV showed reasonable stability throughout youth and young adulthood. This stability might be driven by genetic factors that are expressed consistently over time. We aimed to illustrate the relative contributions of genetic and environmental factors to the stability of carotid-distal PWV from youth to young adulthood. We also examined potential ethnic differences. For this purpose, carotid-distal PWV was measured twice in 497 European American (EA) and African American (AA) twins, with an average interval time of 3 years. Twin modelling on PWV showed that heritability decreased over time (62-35%), with the nonshared environmental influences becoming larger. There was no correlation between the nonshared environmental factors on PWV measured at visit 1 and visit 2, with the phenotypic tracking correlation (r = 0.32) completely explained by shared genetic factors over time. Novel genetic influences were identified accounting for a significant part of the variance (19%) at the second measurement occasion. There was no evidence for ethnic differences. In summary, novel genetic effects appear during development into young adulthood and account for a considerable part of the variation in PWV. Environmental influences become larger with age for PWV.

Ethnicity Differences in Sleep Changes Among Prehypertensive Adults Using a Smartphone Meditation App: Dose-Response Trial.

BACKGROUND: African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs). Meditation may aid in addressing this disparity, although the dosage levels needed to achieve such benefits have not been adequately studied. Smartphone apps present a novel modality for delivering, monitoring, and measuring adherence to meditation protocols. OBJECTIVE: This 6-month dose-response feasibility trial investigated the effects of a breathing awareness meditation (BAM) app, Tension Tamer, on the secondary outcomes of self-reported and actigraphy measures of sleep quality and the modulating effects of ethnicity of AAs and NHWs. METHODS: A total of 64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs) were randomized into 3 different Tension Tamer dosage conditions (5,10, or 15 min twice daily). Sleep quality was assessed at baseline and at 1, 3, and 6 months using the Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring. The study was conducted between August 2014 and October 2016 (IRB #Pro00020894). RESULTS: At baseline, PSQI and actigraphy data indicated that AAs had shorter sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep (range P=.03 to P<.001). Longitudinal generalized linear mixed modeling revealed a dose effect modulated by ethnicity (P=.01). Multimethod assessment showed a consistent pattern of NHWs exhibiting the most favorable responses to the 5-min dose; they reported greater improvements in sleep efficiency and quality as well as the PSQI global value than with the 10-min and 15-min doses (range P=.04 to P<.001). Actigraphy findings revealed a consistent, but not statistically significant, pattern in the 5-min group, showing lower fragmentation, longer sleep duration, and higher efficiency than the other 2 dosage conditions. Among AAs, actigraphy indicated lower sleep fragmentation with the 5-min dose compared with the 10-min and 15-min doses (P=.03 and P<.001, respectively). The 10-min dose showed longer sleep duration than the 5-min and 15-min doses (P=.02 and P<.001, respectively). The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03). CONCLUSIONS: These findings indicate the need for further study of the potential modulating influence of ethnicity on the impact of BAM on sleep indices and user-centered exploration to ascertain the potential merits of refining the Tension Tamer app with attention to cultural tailoring among AAs and NHWs with pre-existing sleep complaints.

High-Mobility Group Box-1 Is Associated With Obesity, Inflammation, and Subclinical Cardiovascular Risk Among Young Adults: A Longitudinal Cohort Study.

OBJECTIVE: We aimed to characterize circulating HMGB1 (high-mobility group box-1) levels, one of the better-characterized damage-associated molecular patterns, with respect to age, sex, and race in the general population, and investigate the longitudinal associations of HMGB1 with inflammatory markers, obesity, and preclinical markers of cardiovascular disease. Approach and Results: The analyses included 489 participants (50% Blacks, aged 24.6±3.3 years at the first visit) with up to 4 follow-up visits (1149 samples) over a maximum of 8.5 years. Systolic blood pressure, diastolic blood pressure, carotid-femoral pulse wave velocity, and carotid intima-media thickness together with plasma HMGB1, hs-CRP (high-sensitivity C-reactive protein), IFN-γ (interferon-γ), IL-6 (interleukin-6), IL-10 (interleukin-10), and TNF-α (tumor necrosis factor-α) were measured at each visit. At baseline, plasma HMGB1 concentrations were higher in Blacks compared with Whites (3.86 versus 3.20 ng/mL, P<0.001), and in females compared with males (3.75 versus 3.30 ng/mL, P=0.005). HMGB1 concentrations increased with age (P=0.007), and higher levels of obesity measures (P<0.001). Without adjustment for age, sex, race, and body mass index, HMGB1 concentrations were positively associated with hs-CRP, IL-6, TNF-α, systolic blood pressure, diastolic blood pressure, and carotid-femoral pulse wave velocity (P<0.05) but not IL-10, IFN-γ or carotid intima-media thickness. After covariate adjustments, the associations of HMGB1 with hs-CRP, and carotid-femoral pulse wave velocity remained statistically significant (P<0.05). CONCLUSIONS: This study demonstrates the age, sex, and race differences in circulating HMGB1. The increasing circulating concentrations of HMGB1 with age suggest a potential role of HMGB1 in the pathogenesis of chronic low-grade inflammation, obesity, and subclinical cardiovascular disease risk.

Serum 25-Hydroxyvitamin D Concentrations Are Associated with Mental Health and Psychosocial Stress in Young Adults.

: We aimed to test the hypothesis that serum 25-hydroxyvitamin D3 (25(OH)D) concentration is associated with mental health and life stress measures in young adults and investigate gender and racial disparities in these associations. This study comprised 327 black and white participants. Depression, trait anxiety, perceived stress, and hostility were measured by the following validated instruments: Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), Perceived Stress Scale (PSS), and Cook-Medley Hostility Scale (CMHS). Linear regression was used to estimate correlations between serum 25(OH)D concentration and mental health measurements in the total population and in subgroups stratified by gender and race. In this sample (28.2 ± 3.1 years, 52% female, 53% black), serum 25(OH)D concentration was negatively related to BDI, STAI, PSS, total CMHS score, and the majority of CMHS subscale scores (p-values < 0.05). Stratified by gender, most of these associations remained significant only in women (p-values < 0.05). Stratified by race, higher 25(OH)D concentrations in white participants were significantly related to lower BDI, STAI, PSS, and CMHS-cynicism subscales (p-values < 0.05); 25(OH)D concentrations in the black participants were only inversely associated with CMHS and most CMHS subscales (p-values < 0.05) but not with BDI, STAI, and PSS. We present novel findings of consistent inverse relationships between serum 25(OH)D concentration and various measures of mental health and life stress. Long-term interventional studies are warranted in order to investigate the roles of vitamin D supplementation in the prevention and mitigation of depression, anxiety, and psychological stress in young adults.

Patient and Parent Perspectives on Improving Pediatric Asthma Self-Management Through a Mobile Health Intervention: Pilot Study.

BACKGROUND: Asthma is a common chronic pediatric disease that can negatively impact children and families. Self-management strategies are challenging to adopt but critical for achieving positive outcomes. Mobile health technology may facilitate self-management of pediatric asthma, especially as adolescents mature and assume responsibility for their disease. OBJECTIVE: This study aimed to explore the perceptions of youths with high-risk asthma and their caregivers on the use of a smartphone app, Smartphone Asthma Management System, in the prevention and treatment of asthma symptoms, possible use of the app to improve self-management of asthma outside traditional clinical settings, and the impact of asthma on everyday life to identify potential needs for future intervention development. METHODS: Key informant interviews were completed with parent-child dyads post participation in an asthma management feasibility intervention study to explore the perceptions of users on a smartphone app designed to monitor symptoms and medication use and offer synchronous and asynchronous provider encounters. A thematic qualitative analysis was conducted inductively through emergent findings and deductively based on the self-determination theory (SDT), identifying 4 major themes. RESULTS: A total of 19 parent-child dyads completed the postintervention interviews. The major themes identified included autonomy, competence, relatedness, and the impact of asthma on life. The participants also shared their perceptions of the benefits and challenges associated with using the app and in the self-management of asthma. Both children and parents conveyed a preference for using technology to facilitate medication and disease management, and children demonstrated a strong willingness and ability to actively engage in their care. CONCLUSIONS: Our study included support for the app and demonstrated the feasibility of enhancing the self-management of asthma by youth in the community. Participant feedback led to intervention refinement and app improvements, and the use of the SDT allowed insight into motivational drivers of behavioral change. The use of mobile apps among high-risk children with asthma and their parents shows promise in improving self-management, medication adherence, and disease awareness and in reducing overall disease morbidity.

Impact of 12-Month Smartphone Breathing Meditation Program upon Systolic Blood Pressure among Non-Medicated Stage 1 Hypertensive Adults.

(1) Background: Hypertension (HTN) affects ~50% of adults and is a major risk factor for stroke and cardiovascular disease. In 2017, the SPRINT trial outcomes led to lowering of HTN cutoffs by the American College of Cardiology (ACC) and American Heart Association (AHA). The Joint National Committee (JNC8) and National High BP Education Program recommend that lifestyle modifications be used as first-line HTN treatment. Chronic stress is a risk factor for HTN and cardiovascular disease. A recently completed 12 month randomized controlled trial (RCT) of a breathing meditation smart phone app (Tension Tamer, TT) involving JNC8 designated pre-HTN adults provided an opportunity to examine its impact upon individuals now classified as having stage 1 HTN. The TT app captures continuous real-time heart rate (HR) from a user's fingertip placed over a video camera lens during sessions. Users receive immediate feedback graphs after each session, showing their HR changes. They also receive motivational and social reinforcement SMS text messages the following day based upon levels of adherence. We conducted ancillary analyses of a 2-arm, 12-month, small-scale efficacy RCT among a subgroup of our total sample of participants, who are now classified as having stage 1 non-medicated systolic HTN. Primary outcome was change in resting systolic blood pressure (SBP). Secondary outcomes were change in resting diastolic blood pressure, adherence to the TT protocol, and perceived stress levels. (2) Methods: 30 adults (mean age: 45.0 years; 15 males; 16 White; 14 Black) with ACC/AHA 2017 defined systolic HTN (130-139 mmHg) on 3 consecutive sessions (mean SBP: 132.6 mmHg) were randomly assigned to TT or lifestyle education program delivered via smartphone (SPCTL). Each group received a twice-daily dosage schedule of TT or walking (month 1: 15 min; months 2 and 3: 10 min; months 4-12: 5 min). (3) Results: Mixed modeling results revealed a significant group x time effect for SBP (p<.01). The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6 (-10.0 vs. -0.7), and 12: (-11.6 vs. -0.4 mmHg; all p-values <0.04). (4) Conclusion: The TT app was beneficial in reducing SBP levels among adults with stage 1 systolic HTN. The TT app may be a promising, scalable first-line tactic for stage 1 HTN. Preparations are underway for an efficacy RCT involving uncontrolled stage 1 HTN patients.

Post-intervention qualitative assessment of mobile health technology to manage hypertension among Ghanaian stroke survivors.

Stroke is a leading cause of death in Africa and a key modifiable risk factor for the index and recurrent stroke is through the adequate management of blood pressure. Recent guidelines encourage management beyond clinic settings, yet implementation of these guidelines can be challenging, especially in resource constrained regions, such as in Sub-Saharan Africa. Mobile health technology may offer an innovative and cost-effective approach to improve BP monitoring and facilitate adherence to antihypertensive medications. Stroke survivors (n = 16) and their caregivers (n = 8) who participated in a 3-month feasibility study were invited to share post-intervention insights via focus groups (n = 3). Clinician (n = 7) input on intervention delivery and clinical impressions was also obtained via a separate focus group (n = 1). Four major themes emerged highlighting the ability to self-monitor, the use of technology as an interventional tool, training and support, and post-intervention adherence. Overwhelming receptivity toward home blood pressure monitoring and the use of mobile health (mHealth) was noted. Feedback indicated benefits in having access to equipment and that message prompts facilitated adherence. Post-intervention adherence declined following study intervention, indicating a need for increased exposure to facilitate long-term behavioral change, although participants conveyed a heightened awareness of the importance of BP monitoring and lifestyle changes needed.

Erratum to stroke patients and their attitudes toward mHealth monitoring to support blood pressure control and medication adherence.

[This corrects the article DOI: 10.21037/mhealth.2016.05.04.].

Using informatics and mobile health to improve medication safety monitoring in kidney transplant recipients.

PURPOSE: The development, testing, and preliminary validation of a technology-enabled, pharmacist-led intervention aimed at improving medication safety and outcomes in kidney transplant recipients are described. SUMMARY: Medication safety issues, encompassing medication errors (MEs), medication nonadherence, and adverse drug events (ADEs), are a predominant cause of poor outcomes after kidney transplantation. However, a limited number of clinical trials assessing the effectiveness of technology in improving medication safety and outcomes in transplant recipients have been conducted. Through an iterative, evidence-based approach, a technology-enabled intervention aimed at improving posttransplant medication safety outcomes was developed, tested, and preliminarily validated. Early acceptability and feasibility results from a prospective, randomized controlled trial assessing the effectiveness of this system are reported here. Of the 120 patients enrolled into the trial at the time of writing, 60 were randomly assigned to receive the intervention. At a mean ± S.D. follow-up of 5.8 ± 4.0 months, there were 2 patient dropouts in the intervention group, resulting in a retention rate of 98%, which was higher than the expected 90% retention rate. CONCLUSION: The development and deployment of a comprehensive medication safety monitoring dashboard for kidney transplant recipients is feasible and acceptable to patients in the current healthcare environment. An ongoing randomized controlled clinical trial is assessing whether such a system reduces MEs and ADRs, leading to improved patient outcomes.

"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial.

BACKGROUND: Kidney transplant recipients' poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK). OBJECTIVE: Our objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care. METHODS: This two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT. RESULTS: The SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants. CONCLUSIONS: This study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13351.

Impact of a Culturally Tailored mHealth Medication Regimen Self-Management Program upon Blood Pressure among Hypertensive Hispanic Adults.

Background: Uncontrolled hypertension (HTN) and medication nonadherence are more prominent among Hispanics compared to non-Hispanic whites and African Americans. Advances in wireless health technology enable real-time monitoring of medication adherence (MA) and blood pressure (BP), facilitating timely patient⁻provider communication including tailored reinforcement/motivational feedback to patients and quicker titration changes by providers. The purpose of the current study was to conduct a 9-month smartphone-enabled efficacy trial addressing MA and BP control among Hispanic adults with uncontrolled HTN and poor MA. Methods: The research design was a 9-month, two-arm efficacy trial including an experimental (Smartphone Med Adherence Stops Hypertension, SMASH) group and an enhanced standard care (ESC) group. SMASH participants utilized a SMASH app which interfaced with a Bluetooth-enabled BP monitor for BP self-monitoring and an electronic medication tray. The ESC participants received text messages including links to PDFs and brief video clips containing healthy lifestyle tips for attention control. Results: Participants were 54 Hispanic adults (mean age: 46.5 years) with uncontrolled HTN. They were randomly assigned to either the SMASH (n = 26) or ESC group (n = 28). At baseline, no participants had controlled systolic BP (SBP). Baseline group averages for SBP between the SC and SMASH groups did not differ (150.7 and 152.3 mmHg, respectively; p = 0.53). At the 1, 3, 6, and 9-month time points, SBP averages were significantly lower in the SMASH versus SC groups (month 1: 125.3 vs. 140.6; month 3: 120.4 vs. 137.5, month 6: 121.2 vs. 145.7 mmHg; month 9: 121.8 vs. 145.7, respectively; all p-values <0.01). At months 3, 6, and 9 there was a significant difference between the percentage of participants meeting the 7th Joint National Committee cutoffs for SBP control in the SC and SMASH groups (month 3: 62.5 vs. 92.0%; month 6: 57.9 and 94.4%, month 9: 27.8 and 92.3%, respectively; all p-values ≤0.01). Average medical regimen adherence, as indicated by timestamped medication intake and BP monitoring for the SMASH group, ranged from 89.1 to 95.2% across the 9-month trial. Conclusion: Our findings indicate that our culturally tailored smartphone-enabled medical regimen self-management program may be an effective solution for the promotion of MA, resulting in statistically and clinically significant reductions in SBP among Hispanic adults with uncontrolled HTN.

Phone-based intervention for blood pressure control among Ghanaian stroke survivors: A pilot randomized controlled trial.

BACKGROUND: The potential of mobile-health (mHealth) technology for the management of hypertension among stroke survivors in Africa remains unexplored. We assessed whether an mHealth technology-enabled, nurse-guided intervention initiated among stroke patients within one month of symptom onset is effective in improving their blood pressure (BP) control. METHODS: A two-arm pilot cluster randomized controlled trial involving 60 stroke survivors, ≥18 years, with BP ≥140/90 mmHg at screening/enrollment visit at a medical center in Ghana. Participants in the intervention arm (n = 30) received a Blue-toothed BP device and smartphone with an App for monitoring BP measurements and medication intake under nurse guidance for three months after which intervention was withdrawn. Control arm (n = 30) received usual care. Primary outcome measure was proportion with clinic BP < 140/90 mmHg at month 9; secondary outcomes included medication adherence. FINDINGS: Mean ± SD age was 55 ± 13 years, 65% males. Two participants on intervention and three in control group were lost to follow-up. At month 9, proportion on the intervention versus controls with BP < 140/90 mmHg was 14/30 (46.7%) versus 12/30 (40.0%), p = 0.79 by intention-to-treat; systolic BP < 140 mmHg was 22/30 (73.3%) versus 13/30 (43.3%), p = 0.035. Mean ± SD medication possession ratio was 0.95 ± 0.16 on intervention versus 0.98 ± 0.24 in the control arm, p = 0.56. INTERPRETATION: We demonstrate feasibility and signal of improvement in BP control among stroke survivors in a resource-limited setting via an mHealth intervention. Larger scale studies are warranted. TRIAL REGISTRATION: NCT02568137. Registered on 13 July 2015 at ClinicalTrials.gov.

Determinants of pulse wave velocity trajectories from youth to young adulthood: the Georgia Stress and Heart Study.

OBJECTIVE: Increased arterial stiffness measured by pulse wave velocity (PWV) has been shown to be an important parameter of cardiovascular risk. Longitudinal development of PWV from youth to early adulthood and its possible sociodemographic, anthropometric, hemodynamic and behavioral moderators will be illustrated. METHODS: Individual growth curves of carotid-distal PWV across age were created for 559 African American and European American men and women with a maximum of five assessments over an average of 7-year follow-up (mean age at participants' first assessment, 22.3 ±â€Š3.4). RESULTS: African Americans and men had significantly higher PWV than did European Americans and women (Ps < 0.01), respectively. A three-way interaction (P < 0.001) between age, sex and ethnicity was observed with African American men displaying a larger rate of increase in PWV with age than the other three ethnic and sex groups. The ethnicity and sex effects on PWV persisted when controlling for other moderators. Waist circumference was the strongest anthropometric predictor but its effect on PWV was only significant in women. Mean arterial pressure was the strongest hemodynamic predictor, marital status of parents was the strongest socioeconomic predictor and marijuana use was the strongest behavioral predictor of PWV. The best-fitting full model explained in total 59.4% of the between-subject variance in PWV with ethnicity, sex and age explaining 25.6%. CONCLUSION: We observed significant ethnic and sex differences in longitudinal trajectories of PWV in youth and young adults. In addition, individual differences in PWV growth can largely be explained by mean arterial pressure, waist, marital status of parents and marijuana use.

Angiotensin II and the Natriuretic and Blood Pressure Response to Mental Stress in African Americans.

Objective: To test the hypothesis that Angiotensin II (Ang II) is a contributing factor to the response pattern in African Americans (AAs) who retain rather than excrete sodium during mental stress. Design/Study Participants: Double-blind, randomized, cross-over trial of 87 healthy AAs aged 18 to 50 years. Interventions: The study participants received either a placebo or irbesartan, (150 mg PO), an Ang II receptor antagonist, for seven days prior to stress testing. Urinary sodium excretion (UNaV) and systolic blood pressure (SBP) were collected prior to and throughout a mental stress protocol (rest and stress period). Setting: A southeastern university. Main Outcome Measures: Ang II, SBP, and sodium retention. Results: During the placebo condition, 62 participants showed the expected increase in UNaV (excreters) while 25 participants reduced UNaV during stress (retainers). Irbesartan retainers demonstrated a reversal in the direction of their natriuretic response, now increasing UNaV in response to stress (∆ UNaV of -.094 mmol/min with placebo vs .052 mmol/min on irbesartan; P<.001). In excreters, irbesartan reduced SBP levels during both rest (-2.36 mm Hg; P=.03) and stress (-4.59;P<.0001), and an even more pronounced reduction in SBP was demonstrated by retainers on treatment during both rest (-4.29 mm Hg; P=.03) and stress (-6.12; P<.001). Conclusions: Ang II contributes to sodium retention in retainers. Furthermore, our findings indicate that suppression of Ang II has a beneficial effect on SBP during rest and stress in this population.