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BackgroundDREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower Blood Pressure in Indigenous and low- and middle-income countries) studied a SMS text messaging–based system for blood pressure measurement and hypertension management in Canadian Aboriginal and Tanzanian communities. The use of SMS text messages is an emerging point of interest in global health care initiatives because of their scalability, customizability, transferability, and cost-effectiveness. ObjectiveThe study aim was to assess the effect on the difference in blood pressure reduction of active hypertension management messages or passive health behavior messages. The system was designed to be implemented in remote areas with wireless availability. This study described the implementation and evaluation of technical components, including quantitative data from the transmission of blood pressure measurements and qualitative data collected on the operational aspects of the system from participants, health care providers, and community leadership. MethodsThe study was implemented in six remote Indigenous Canadian and two rural Tanzanian communities. Blood pressure readings were taken by a community health worker and transmitted to a mobile phone via Bluetooth, then by wireless to a programmed central server. From the server, the readings were sent to the participant’s own phone as well. Participants also received biweekly tailored SMS text messages on their phones. Quantitative data on blood pressure reading transmissions were collected from the study central server. Qualitative data were collected by surveys, focus groups, and key informant interviews of participants, health care providers, and health leadership. ResultsIn Canada, between February 2014 and February 2017, 2818 blood pressure readings from 243 patients were transmitted to the central server. In Tanzania, between October 2014 and August 2015, 1165 readings from 130 patients were transmitted to the central server. The use of Bluetooth technology enabled the secure, reliable transmission of information from participants to their health care provider. The timing and frequency were satisfactory to 137 of 187 (73.2%) of participants, supporting the process of sending weekly messages twice on Mondays and Thursdays at 11 am. A total of 97.0% (164/169) of the participants surveyed said they would recommend participation in the DREAM-GLOBAL program to a friend or relative with hypertension. ConclusionsIn remote communities, the DREAM-GLOBAL study helped local health care providers deliver a blood pressure management program that enabled patients and community workers to feel connected. The technical components of the study were implemented as planned, and patients felt supported in their management through the SMS text messaging and mobile health program. Technological issues were solved with troubleshooting. Overall, the technical aspects of this research program enhanced clinical care and study evaluation and were well received by participants, health care workers, and community leadership. Trial RegistrationClinicaltrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226.

BackgroundTo facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. ObjectiveBuilding on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension—Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. MethodsOur literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. ResultsFour human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and settings. These four levels represent evaluation domains and became the core focus of the evaluation. In addition, primary implementation themes to explore in each of the domains were identified as follows: (1) the major active components of the intervention, (2) technology of the intervention, (3) cultural congruence, (4) task shifting, and (5) unintended consequences. Using the four organizational domains and their interaction with primary implementation themes, we developed detailed evaluation research questions and identified the data or information sources to best answer our questions. ConclusionsUsing DREAM-GLOBAL to illustrate our approach, we succeeded in developing an uncomplicated process evaluation framework for mHealth interventions that provide key information to stakeholders, which can optimize implementation of a pragmatic trial as well as inform scale up. The human organizational level domains used to focus the primary implementation themes in the DREAM-GLOBAL process evaluation framework are sufficiently supported in our research, and the literature and can serve as a valuable tool for other mHealth process evaluations. Trial RegistrationClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege)

BackgroundMobile-cellular subscriptions have increased steadily over the past decade. The accessibility of SMS messages over existing mobile networks is high and has almost universal availability even on older and unsophisticated mobile phones and in geographic settings where wireless coverage is weak. There is intensive exploration of this inexpensive mobile telecommunication technology to improve health services and promote behavior change among vulnerable populations. However, a neglected area of research is the documentation and critical analysis of the formative research process required in the development and refinement of effective SMS messages. ObjectiveThe objective of this qualitative research study was to identify major factors that may impact on the effectiveness of evidence-based SMS messages designed to reduce health inequities in hypertension management in low resource settings, including Aboriginal populations in high-income countries and rural populations in low-income countries. Specifically, we were interested in uncovering the range of mediators that impact on appropriate message content transmission and, ultimately, on health behavior improvements in a range of these sociocultural settings. MethodsCollaborative qualitative research with Canadian Aboriginal and Tanzanian participants was conducted to deconstruct the content and transmission of evidence-based health information contained in SMS messages in the context of an international research project designed to address health inequalities in hypertension, and to develop a grounded theory of the major factors that mediate the effectiveness of this communication. We also examined the interrelationship of these mediators with the three essential conditions of the behavior system of the Behavioral Change Wheel model (capability, opportunity, and motivation) and cultural safety. ResultsFour focus groups with a total of 45 participants were conducted. Our grounded theory research revealed how discrepancies develop between the evidence-based text message created by researchers and the message received by the recipient in mobile health interventions. These discrepancies were primarily generated by six mediators of meaning in SMS messages: (1) negative or non-affirming framing of advocacies, (2) fear- or stress-inducing content, (3) oppressive or authoritarian content, (4) incongruity with cultural and traditional practices, (5) disconnect with the reality of the social determinants of health and the diversity of cultures within a population, and (6) lack of clarity and/or practicality of content. These 6 mediators of meaning provide the basis for sound strategies for message development because they impact directly on the target populations’ capability, opportunity, and motivation for behavior change. ConclusionsThe quality of text messages impacts significantly on the effectiveness of a mobile health intervention. Our research underscores the urgent need for interventions to incorporate and evaluate the quality of SMS messages and to examine the mediators of meaning within each targeted cultural and demographic group. Reporting on this aspect of mobile health intervention research will allow researchers to move away from the current black box of SMS text message development, thus improving the transparency of the process as well as the quality of the outcomes.

Hypertension, the leading cause of cardiovascular morbidity and mortality, affects more than 1 billion people globally. The rise in mobile health in particular the use of mobile phones and short message service (SMS) to support disease management provides an opportunity to improve hypertension awareness, treatment, and control, in remote and vulnerable patient populations. The primary objective of this randomized controlled study was to assess the effect of active (with hypertension specific management SMS) or passive (health behaviors SMS alone) on the difference in blood pressure (BP) reduction between the active and passive SMS groups in hypertensive Canadian First Nations people from six rural and remote communities. Pragmatic features of the study included shifting of BP measures to non-medical health workers. Despite an overall reduction in BP over the study, there was no difference in the BP change between groups from baseline to final for systolic 0.8 (95% CI -4.2 to 5.8 mm Hg) or diastolic -1.0 (95% CI -3.7 to 1.8 mm Hg, P = 0.5) BP. Achieved BP control was 37.5% (25.6%-49.4%, 95% CI) in the active group and 32.8% (20.6%-44.8%, 95% CI) in the passive group (difference in proportions -4.74% (-21.7% to 12.2%, 95% CI, P = 0.6). The study looked at changes in health services delivery, mobile health technologies, and patient engagement to support better management of hypertension in Canadian First Nations communities. The active hypertension specific SMS did not lead to improvements in BP control. [ABSTRACT FROM AUTHOR]

Background: Hypertension, the leading cause of morbidity and mortality, affects more than 1 billion people and is responsible globally for 10 million deaths annually. Hypertension can be controlled on a national level; in Canada, for example, awareness, treatment, and control improved dramatically from only 16% in 1990 to 66% currently. The ongoing development, dissemination, and implementation of Hypertension Canada's clinical practice guidelines is considered to be responsible, in part, for achieving these high levels of control and the associated improvements in cardiovascular outcomes. A gap still exists between the evidence and the implementation of hypertension guidelines in Indigenous communities in Canada, as well as in low- and middle-income countries (LMICs). The rapid rise in the ownership and use of mobile phones globally and the potential for texting (short message service, SMS) to improve health literacy and to link the health team together with the patient served as a rationale for the Dream-Global study in both Canada and Tanzania. Objective: The primary objective of the Dream-Global study is to assess the effect of innovative technologies and changes in health services delivery on blood pressure (BP) control of Indigenous people in Canada and rural Tanzanians with hypertension using SMS messages and community BP measurement through task shifting with transfer of the measures electronically to the patient and the health care team members. Methods: This prospective, randomized blinded allocation study enrolls both adults with uncontrolled hypertension (medicated or unmedicated) and those without hypertension but at high risk of developing this condition who participate in a BP screening study. Participants will be followed for at least 12 months. Results: The primary efficacy endpoint in this study will be assessed by analysis of variance. Descriptive data will be given with the mean and standard deviation for continuous data and proportions for ordinal data. Exploratory subgroup analyses will include analysis by community, sex, mobile phone ownership at baseline, and age. The knowledge gained from the text messages will be assessed using a questionnaire at study completion, and results will be compared between the groups. Conclusions: This study is expected to provide insights into the implementation of an innovative system of guidelines- and community-based treatment and follow-up for hypertension in Indigenous communities in Canada and in Tanzania, an example of an LMIC. These insights are expected to provide the information needed to plan scalable and sustainable interventions to control BP virtually anywhere in the world. Trial Registration: Clinicaltrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6v7IdYzZh) [ABSTRACT FROM AUTHOR]