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Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time. The aim of this study was to assess the feasibility, acceptability, and preliminary outcomes of a prototype mobile health (mHealth) medication and blood pressure (BP) self-management system for kidney transplant patients with uncontrolled hypertension. A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design. The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback. A 3-month proof-of-concept randomized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray. Participants randomized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging. Controls received standard of care and their adherence continued to be monitored with the medication tray reminders turned off. Providers received weekly summary reports of patient medication adherence and BP readings. Participation and retention rates were 41/55 (75%) and 31/34 (91%), respectively. The prototype system appears to be safe, highly acceptable, and useful to patients and providers. Compared to the standard care control group (SC), the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations. Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the standard care group (7 adjustments in 5 patients versus 3 adjustments in 3 patients) during the 3-month trial based on the information provided in the weekly reports. These data support the acceptability and feasibility of the prototype mHealth system. Further trials with larger sample sizes and additional biomarkers (eg, whole blood medication levels) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control after kidney transplantation over longer time periods. Clinicaltrials.gov NCT01859273; http://clinicaltrials.gov/ct2/show/NCT01859273 (Archived by WebCite at http://www.webcitation.org/6IqfCa3A3).

Mobile phone-based interventions present a means of providing high quality health care to hard-to-reach underserved populations. Migrant farm workers (MFWs) are among the most underserved populations in the United States due to a high prevalence of chronic diseases yet limited access to health care. However, it is unknown if MFWs have access to mobile phone devices used in mobile health (mHealth) interventions, or if they are willing to use such technologies. Determine rates of ownership of mobile devices and willingness to use mHealth strategies in MFWs. A demonstration of mHealth devices and a survey were individually administered to 80 Hispanic MFWs to evaluate use of mobile phones and mHealth devices and willingness to use such technologies. Of the 80 participants, 81% (65/80) owned cell phones capable of sending and receiving health-related messages. Most participants (65/80, 81%) were receptive to using mHealth technology and felt it would be helpful in enhancing medication adherence, self-monitoring health conditions, and receiving quicker medication changes from their doctors (median scores ≥4 on 5-point Likert scales). Relations between age and attitudes toward using mHealth were not statistically significant. Hispanic MFWs have access to mobile phones and are willing to use mHealth devices. Future work is needed to comprehensively evaluate the degree to which these devices could be used.

Background Cocaine and methamphetamine use disorders (CcUD/MtUD) have serious public health, medical, and psychiatric consequences. Yet, there are no U.S. Food and Drug Administration (FDA) approved treatments available. The STIMULUS study is a multi-site trial, sponsored by the National Drug Abuse Treatment Clinical Trials Network (CTN), that aims to investigate the feasibility and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for moderate to severe CcUD/MtUD. Methods The study is a double-blind, sham-controlled trial seeking to recruit 160 participants with a current moderate to severe CcUD or MtUD diagnosis, randomized to receive active rTMS (10-Hz stimulation at 120% motor threshold over the left dorsolateral prefrontal cortex) or sham. Feasibility is assessed by a target of at least 20 treatment sessions administered within an 8-week period. Additionally, the study aims to evaluate the efficacy of rTMS in reducing stimulant use and craving, the impact of rTMS on mood, anxiety, sleep, and other measures, and the utility of electroencephalography as a treatment response biomarker. Discussion Studies exploring rTMS for stimulant use disorders remain limited by small sample sizes, as well as great heterogeneity in defined study population, treatment parameters, retention in treatment, and number of sessions. In this paper, we highlight key study design decisions, such as safety, sham procedure, and schedule flexibility. Conclusion We hope that the data collected will lay the groundwork for a robust randomized controlled trial of rTMS as a therapeutic intervention for individuals with CcUD/MtUD. Trial registration http://www.ClinicalTrials.gov . Identifier: NCT04907357. Trial data set https://clinicaltrials.gov/study/NCT04907357?tab=table . Protocol Version 7.0, 11/10/2023.

Mobile phone based remote monitoring of medication adherence and physiological parameters has the potential of improving long-term graft outcomes in the recipients of kidney transplants. This technology is promising as it is relatively inexpensive, can include intuitive software and may offer the ability to conduct close patient monitoring in a non-intrusive manner. This includes the optimal management of comorbidities such as hypertension and diabetes. There is, however, a lack of data assessing the attitudes of renal transplant recipients toward this technology, especially among ethnic minorities. To assess the attitudes of renal transplant recipients toward mobile phone based remote monitoring and management of their medical regimen; and to identify demographic or clinical characteristics that impact on this attitude. After a 10 minute demonstration of a prototype mobile phone based monitoring system, a 10 item questionnaire regarding attitude toward remote monitoring and the technology was administered to the participants, along with the 10 item Perceived Stress Scale and the 7 item Morisky Medication Adherence Scale. Between February and April 2012, a total of 99 renal transplant recipients were identified and agreed to participate in the survey. The results of the survey indicate that while 90% (87/97) of respondents own a mobile phone, only 7% (7/98) had any prior knowledge of mobile phone based remote monitoring. Despite this, the majority of respondents, 79% (78/99), reported a positive attitude toward the use of a prototype system if it came at no cost to themselves. Blacks were more likely than whites to own smartphones (43.1%, 28/65 vs 20.6%, 7/34; P=.03) and held a more positive attitude toward free use of the prototype system than whites (4.25±0.88 vs 3.76±1.07; P=.02). The data demonstrates that kidney transplant recipients have a positive overall attitude toward mobile phone based health technology (mHealth). Additionally, the data demonstrates that most kidney transplant recipients own and are comfortable using mobile phones and that many of these patients already own and use smart mobile phones. The respondents felt that mHealth offers an opportunity for improved self-efficacy and improved provider driven medical management. Respondents were comfortable with the idea of being monitored using mobile technology and are confident that their privacy can be protected. The small subset of kidney transplant recipients who are less interested in mHealth may be less technologically adept as reflected by their lower mobile phone ownership rates. As a whole, kidney transplant recipients are receptive to the technology and believe in its utility.

Context— Very few patient-centered, theory-guided programs for medication adherence and blood pressure control have been conducted in kidney transplant recipients. Objective— To evaluate preliminary indications of sustainability of improved blood pressure in kidney transplant recipients 12 months after completion of a 3-month randomized controlled trial of a mobile health pilot program to improve blood pressure and medication adherence. Participants and Design— A total of 18 of the 19 trial participants were contacted and all consented to inclusion in the retrospective analysis of their medical records showing their clinic-recorded systolic blood pressures at 3, 6, and 12 months following participation in the 3-month trial of a medical regimen self-management intervention. Results— A significant group difference in systolic blood pressure was observed longitudinally, indicating that the intervention group, as compared with the standard-care group, exhibited lower clinic-measured systolic blood pressures at the 12-month posttrial follow-up visit (P = .01). At 12-month follow-up, success in establishing and sustaining control of systolic blood pressure (<131 mm Hg) was greater in the intervention group (50%) than in the control group (11%). Conclusion— Patients in the intervention group continued to exhibit lower systolic blood pressure than did patients in the control group 12 months after the trial ended, suggesting that the intervention may have a durable impact on blood pressure control that most likely reflects sustained medication adherence. These findings will aid in the development of an adequately powered randomized controlled trial to address the sustainable impact of the intervention program on medication adherence and blood pressure control.

Patient nonadherence to medication regimens and provider therapeutic inertia (failure to respond in timely manner to clinical data) are two primary contributors to ineffective chronic disease management. This 3-month proof of concept trial used an iterative design approach guided by self-determination theory and the technology acceptance model to develop a culturally sensitive, patient-centered, and provider-centered mobile health medication and blood pressure self-management program. Cellular connected electronic medication trays provided reminder signals for patients to take medications and smartphone messaging reminded patients to take at-home blood pressures using a Bluetooth-enabled monitor. Providers were given bimonthly feedback. Motivational and reinforcement text and audio messages were sent based upon medication adherence rates and blood pressure levels. Ten Hispanics with uncontrolled essential hypertension were randomized to standard care and Smartphone Medication Adherence Stops Hypertension (SMASH) intervention groups. Primary outcomes of provider and patient acceptability of the program were found to be high. Retention rates for the 3-month program were 100%, with mean ± standard deviation overall medication adherence for the SMASH group at 97.2% ± 2.8%, with all strongly believing the program helped them remember to take their medication. SMASH participants measured their blood pressure every 3 days 83.2% ± 6.0% of the time and completed 89.2% ± 19.06% of the expected readings. Nonparametric tests showed statistical significance for resting blood pressure changes between groups at months 2 (P = 0.016) and 3 (P = 0.008), with a pre-intervention to 3-month mean systolic blood pressure reduction of 47.2 mmHg for the SMASH group compared with a reduction of 12 mmHg for the standard care group. Change in scores between pre-intervention and months 1, 2, and 3 for ambulatory blood pressure values found that the SMASH group exhibited consistently greater reductions for 24-hour, wake, and sleep categories compared with little change in the standard care group, although statistical significance was not reached. Principles of patient-centered care highlight partnering with intended users and implementers are important when developing a culturally sensitive intervention that is meaningful and effective. Keywords: medication adherence, clinical inertia, self-determination theory, mHealth, blood pressure control, essential hypertension, Hispanics

African Americans and Hispanics have disproportionate rates of uncontrolled essential hypertension (EH) compared to Non-Hispanic Whites. Medication non-adherence (MNA) is the leading modifiable behavior to improved blood pressure (BP) control. The Smartphone Medication Adherence Stops Hypertension (SMASH) program was developed using a patient-centered, theory-guided, iterative design process. Electronic medication trays provided reminder signals, and Short Message Service [SMS] messaging reminded subjects to monitor BP with Bluetooth-enabled monitors. Motivational and reinforcement text messages were sent to participants based upon levels of adherence. Thirty-eight African-American (18) and Hispanic (20) uncontrolled hypertensives completed clinic-based anthropometric and resting BP evaluations prior to randomization, and again at months 1, 3 and 6. Generalized linear mixed modeling (GLMM) revealed statistically significant time-by-treatment interactions (p < 0.0001) indicating significant reductions in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) for the SMASH group vs. the standard care (SC) control group across all time points. 70.6% of SMASH subjects vs. 15.8% of the SC group reached BP control (< 140/90 mmH) at month 1 (p < 0.001). At month 6, 94.4% of the SMASH vs. 41.2% of the SC group exhibited controlled BP (p < 0.003). Our findings provide encouraging evidence that efficacious mHealth, chronic disease, medical regimen, self-management programs can be developed following principles of patient-centered, theory-guided design.

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. 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. 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). 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). 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.

There is a critical need to expand the pool of available kidneys for African Americans who are on the transplant wait-list due to the disproportionally lower availability of deceased donor kidneys compared with other races/ethnic groups. Encouraging living donation is one method to fill this need. Incorporating mHealth strategies may be a way to deliver educational and supportive services to African American transplant-eligible patients and improve reach to those living in remote areas or unable to attend traditional group-session-based programs. Before program development, it is essential to perform formative research with target populations to determine acceptability and cultivate a patient-centered and culturally relevant approach to be used for program development. The objectives of this study were to investigate African American kidney transplant recipients' and kidney donors'/potential donors' attitudes and perceptions toward mobile technology and its viability in an mHealth program aimed at educating patients about the process of living kidney donation. Using frameworks from the technology acceptance model and self-determination theory, 9 focus groups (n=57) were administered to African Americans at a southeastern medical center, which included deceased/living donor kidney recipients and living donors/potential donors. After a demonstration of a tablet-based video education session and explanation of a group-based videoconferencing session, focus groups examined members' perceptions about how educational messages should be presented on topics pertaining to the process of living kidney donation and the transplantation. Questionnaires were administered on technology use and perceptions of the potential program communication platform. Transcripts were coded and themes were examined using NVivo 10 software. Qualitative findings found 5 major themes common among all participants. These included the following: (1) strong support for mobile technology use; (2) different media formats were preferred; (3) willingness to engage in video chats, but face-to-face interaction sometimes preferred; (4) media needs to be user friendly; (5) high prevalence of technology access. Our results show that recipients were willing to spend more time on education than the donors group, they wanted to build conversation skills to approach others, and preferred getting information from many sources, whereas the donor group wanted to hear from other living donors. The questionnaires revealed 85% or more of the sample scored 4+ on a 5-point Likert scale, which indicates high degree of interest to use the proposed program, belief that other mHealth technologies would help with adherence to medical regimens, and doctors would make regimen adjustments quicker. In addition, high utilization of mobile technology was reported; 71.9% of the participants had a mobile phone and 43.9% had a tablet. Our study supports the use of an mHealth education platform for African Americans to learn about living donation. However, potential recipients and potential donors have differing needs, and therefore, programs should be tailored to each target audience.