Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial.

BACKGROUND: There is a paucity of controlled clinical trial data based on research with Indigenous peoples. A lack of data specific to Indigenous peoples means that new therapeutic methods, such as those involving electronic health (eHealth), will be extrapolated to these groups based on research with other populations. Rigorous, ethical research can be undertaken in collaboration with Indigenous communities but requires careful attention to culturally safe research practices. Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research. To be effective, researchers must first gain an in-depth understanding of Indigenous determinants of health, including the harmful consequences of colonialism. Second, researchers need to learn how colonialism affects the research process. The challenge then for eHealth researchers is to braid Indigenous ethical values with the requirements of good research methodologies into a culturally safe research protocol. OBJECTIVE: A recent systematic review showed that Indigenous peoples are underrepresented in randomized controlled trials (RCTs), primarily due to a lack of attention to providing space for Indigenous perspectives within the study frameworks of RCTs. Given the lack of guidelines for conducting RCTs with Indigenous communities, we conducted an analysis of our large evaluation data set collected in the Diagnosing Hypertension-Engaging Action and Management in Getting Lower Blood Pressure in Indigenous Peoples and Low- and Middle- Income Countries (DREAM-GLOBAL) trial over a period of five years. Our goal is to identify wise practices for culturally safe, collaborative eHealth and RCT research with Indigenous communities. METHODS: We thematically analyzed survey responses and qualitative interview/focus group data that we collected over five years in six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL. We established themes that reflect culturally safe approaches to research and then developed wise practices for culturally safe research in pragmatic eHealth research. RESULTS: Based on our analysis, successful eHealth research in collaboration with Indigenous communities requires a focus on cultural safety that includes: (1) building a respectful relationship; (2) maintaining a respectful relationship; (3) good communication and support for the local team during the RCT; (4) commitment to co-designing the innovation; (5) supporting task shifting with the local team; and (6) reflecting on our mistakes and lessons learned or areas for improvement that support learning and cultural safety. CONCLUSIONS: Based on evaluation data collected in the DREAM-GLOBAL RCT, we found that there are important cultural safety considerations in Indigenous eHealth research. Building on the perspectives of Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities. TRIAL REGISTRATION: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226.

Assessing the Governance of Digital Contact Tracing in Response to COVID-19: Results of a Multi-National Study.

This paper describes the results of a multi-country survey of governance approaches for the use of digital contact tracing (DCT) in response to the COVID-19 pandemic. We argue that the countries in our survey represent two distinct models of DCT governance, both of which are flawed. The "data protection model" emphasizes privacy protections at the expense of public health benefit, while the "emergency response model" sacrifices transparency and accountability, prompting concerns about excessive governance surveillance. The ethical and effective use of DCT in the future requires a new governance approach that is better suited to this novel use of mobile phone data to promote public health."

Blood pressure 2 years after a chronic disease management intervention study.

OBJECTIVES: To follow blood pressure change over time in participants who had participated in a 1- year chronic disease management program focused on blood pressure reduction. The expectation was that blood pressure would return back to the baseline once the study was completed. STUDY DESIGN: Prospective, single-arm observational study. METHODS: Study participants were Status Indians living on-reserve with type 2 diabetes and persistent hypertension who had participated in the DREAM3 study. Blood pressure was measured with the BpTRU automated device every 6 months for 2 years. The primary endpoint was the change in systolic blood pressure over the follow-up period. RESULTS: Sixty of the original 96 participants agreed to participate in the follow-up. Mean blood pressure at the beginning of the follow-up was 130/76 (SD 18/12) mmHg. Mean blood pressure at the end of the follow-up period was 132/76 (17/9 SD) mmHg. Target blood pressure (<130/80 mmHg) was present in 53%. The 99% confidence limit around change of blood pressure over the 24 months of follow-up was +/-4.7 mmHg. CONCLUSIONS: Contrary to expectations, the participants maintained their blood pressure control and did not revert to baseline levels. Community awareness and engagement resulting from the chronic disease management program led to a sustainable improvement in the health parameters of the participants and the community that lasted beyond the duration of the 1-year DREAM3 project.

DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol.

BACKGROUND: The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management. METHODS AND DESIGN: The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed. DISCUSSION: The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management. TRIAL REGISTRATION: Protocol NCT00325624.

Diagnosing hypertension in Indigenous Canadians (DREAM-GLOBAL): A randomized controlled trial to compare the effectiveness of short message service messaging for management of hypertension: Main results.

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.

Analysis of the Implementation, User Perspectives, and Feedback From a Mobile Health Intervention for Individuals Living With Hypertension (DREAM-GLOBAL): Mixed Methods Study.

BACKGROUND: DREAM-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. OBJECTIVE: The 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. METHODS: The 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. RESULTS: In 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. CONCLUSIONS: In 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 REGISTRATION: Clinicaltrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226.

Heart and Stroke Foundation of Ontario (HSFO) high blood pressure strategy's hypertension management initiative study protocol.

BACKGROUND: Achieving control of hypertension prevents target organ damage at both the micro and macrovascular level and is a highly cost effective means of lowering the risk for heart attack and stroke particularly in people with diabetes. Clinical trials demonstrate that blood pressure control can be achieved in a large proportion of people. Translating this knowledge into widespread practice is the focus of the Hypertension Management Initiative, which began in 2004 with the goal of improving the management of this chronic health condition by primary care providers and patients in the community. METHODS: This study will test the effect of a systems change on the management of high blood pressure in real world practice in primary care in Ontario, Canada. The systems change intervention involves an interprofessional educational program bringing together physicians, nurses and pharmacists with tools for both providers and patients to facilitate blood pressure management. Each of two waves of subjects were enrolled over a 6 month period with the initial enrollment between waves separated by 9 months. Blood pressure will be measured with the BpTru automated blood pressure device. To determine the effectiveness of the intervention, a before and after analysis within all subjects will compare blood pressure at baseline to annual measurements for the three year study. To assess whether the intervention has an impact on blood pressure control independent of community trends, a betwen group comparison of baseline blood pressures in the delayed wave will be made with the immediate wave during the same time period, so that the immediate wave has experienced the intervention for at least 9 months. The total enrollment goal is 5,000 subjects. The practice locations include 10 Family Health Teams (FHTs) and 1 Community Health Centre (CHC) and approximately 49 primary care physicians, 15 nurse practitioners, 37 registered nurses and over 150 community pharmacists across the 11 communities throughout the province of Ontario. The 11 primary care sites will be divided into immediate and delayed groups based on geography and the use of an electronic versus a traditional chart patient record. DISCUSSION: Initial consideration was given to randomizing the groups, however, for a number of reasons, this was deemed to not be possible. In order to ensure that the sites in the immediate intervention and delayed intervention groups are not different from each other, the sites will be assigned to the intervention groups manually to ensure a distribution of the variables as evenly as possible. Given that HSFO approached this particular group of health care providers to participate in a program relating to hypertension, this may have heightened their awareness of the issue and affected their management of patients with hypertension. Thus, data will be collected to allow an assessment of previous practice patterns and determine any impact of the Hawthorne Effect. TRIAL REGISTRATION: Clinicaltrials.gov NCT00425828.

Diabetes risk evaluation and microalbuminuria (DREAM) studies: ten years of participatory research with a First Nation's home and community model for type 2 diabetes care in Northern Saskatchewan.

OBJECTIVES: To review the DREAM studies and the role of participatory research using a Home and Community Care model in treating First Nations diabetes. STUDY DESIGN: Population survey, pilot and prospective randomized trial METHODS: Review documented history of these studies since inception. Collation of all data from the DREAM studies from 1998 to the present, including interviews with all providers and many of the participants. RESULTS: The DREAM studies were a participatory process providing a needs assessment and became the foundation for this First Nation's Home and Community Care team involvement in providing community-based chronic-disease management. The findings motivated the community to find a process that would lead to needed changes. This participatory research enabled a culturally tailored algorithm of evidence-based management of hypertension and disease management strategies for people with diabetes. These studies demonstrated that in this community the Home and Community Care team could work together with primary care physicians and specialists to prevent the complications of diabetes. CONCLUSIONS: The DREAM studies demonstrated in the first controlled trial that with participatory research a systems change is possible; a chronic-disease management model utilizing a trained multidisciplinary Home and Community Care team and informed patients can lead to lower blood pressure in a Canadian First Nations population with diabetes.

A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings.

BACKGROUND: To 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. OBJECTIVE: Building 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. METHODS: Our 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. RESULTS: Four 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. CONCLUSIONS: Using 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 REGISTRATION: ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226 (Archived by WebCite at http://www.webcitation.org/6oxfHXege).

The Effectiveness of Text Messaging for Detection and Management of Hypertension in Indigenous People in Canada: Protocol for a Randomized Controlled Trial.

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).

The effect of alcohol and gender on ambulatory blood pressure: results from the Baseline Double Exposure study.

BACKGROUND: Research has demonstrated that psychosocial and lifestyle factors are associated with sustained increases in blood pressure (BP). METHODS: Using post-hoc analyses from the Baseline Double Exposure cohort study, alcohol consumption and gender were examined as to their association with ambulatory BP (ABP) in participants with normal or elevated and untreated BP. RESULTS: The current study included 248 subjects, 135 (54.4%) of whom were women, with a mean age (+/- SD) of 50.8 +/- 6.6 years. The main effects model, which included BMI, multiple regression analysis with 24 h systolic BP as the dependent variable found that alcohol consumption (P = .033), male gender (P = .004), and age (P = .039) were significant variables associated with higher systolic BP, whereas exercise (P = .037) was associated with lower systolic BP. From the regression analysis, the independent effect of alcohol consumption (> or = 10 drinks per week) on systolic BP was 4.4 mm Hg for all subjects during 24 h and 7.1 mm Hg during spousal contact, whereas in women with this degree of alcohol consumption the effect on systolic BP was 8.4 mm Hg during 24 h and 11.4 mm Hg during spousal contact. When the interaction term of gender by drinking status was added to the same regression model, the term was not significant for systolic BP during 24 h, but was significant during spousal contact time (P = .047). CONCLUSIONS: The current study demonstrates an association between alcohol with higher systolic BP, more pronounced in women than men, particularly during spousal contact time. This is the first time that the interaction of alcohol and gender with ABP has been demonstrated.

Effect of nurse-directed hypertension treatment among First Nations people with existing hypertension and diabetes mellitus: the Diabetes Risk Evaluation and Microalbuminuria (DREAM 3) randomized controlled trial.

BACKGROUND: First Nations people with diabetes mellitus and hypertension are at greater risk of renal and cardiovascular complications than are non-native patients because of barriers to health care services. We conducted this randomized controlled trial to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes. METHODS: We compared 2 community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in the change in systolic blood pressure after 12 months. Secondary outcome measures were the change in diastolic blood pressure over time, the change in urine albumin status and the incidence of adverse events. RESULTS: Both groups experienced a significant reduction in systolic blood pressure by the final visit (by 24.0 [standard deviation (SD) 13.5] mm Hg in the intervention group and by 17.0 [SD 18.6] mm Hg in the control group); p < 0.001 in each case). However, the difference between the 2 groups in this change was not significant. Patients in the intervention group had a larger decrease in diastolic blood pressure over time than did those in the control group (by 11.6 [SD 10.6] mm Hg v. 6.8 [SD 11.1] mm Hg respectively; p = 0.05). The groups did not differ significantly in terms of changes in urine albumin excretion or incidence of adverse events. INTERPRETATION: High rates of blood pressure control in the community were achieved in both groups in the DREAM 3 study. The addition of a home care nurse to implement a treatment strategy for blood pressure control was more effective in lowering diastolic than systolic blood pressure compared with home care visits for blood pressure monitoring alone and follow-up treatment by a family physician.

Unpacking the Black Box: A Formative Research Approach to the Development of Theory-Driven, Evidence-Based, and Culturally Safe Text Messages in Mobile Health Interventions.

BACKGROUND: Mobile-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. OBJECTIVE: The 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. METHODS: Collaborative 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. RESULTS: Four 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. CONCLUSIONS: The 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.

Impact of job and marital strain on ambulatory blood pressure results from the double exposure study.

BACKGROUND: Psychosocial stressors such as job strain and marital stress have been associated with a sustained increase in blood pressure (BP). METHODS: We evaluated whether job strain and marital cohesion were associated with ambulatory BP in workers with normal or untreated elevated BP using baseline data from the Double Exposure study. The study population included 248 male and female volunteers who were nonmedicated, employed, and living with a significant other, all for a minimum of 6 months. Blood pressure was measured with an ambulatory BP monitor and participants completed a diary that recorded time during work, spousal contact, and sleep. Job strain and marital cohesion were calculated from the Job Content Questionnaire and the Dyadic Adjustment Scale, respectively. RESULTS: Of the subjects, 54.4% were female with a mean age of 50.8 years (6.6, SD). In all, 21.3% reported job strain. Significant assocations were found between 24-h systolic BP (SBP) and alcohol consumption (P = .033), job strain (P = .007), male gender (P = .004), and age (P = .039) and was inversely associated with exercise (P = .037). An interaction between 24-h SBP, job strain, and marital cohesion was found such that greater marital cohesion was associated with lower SBP in subjects with job strain. CONCLUSIONS: Psychosocial factors may influence the development of early hypertension. This should be clarified by the cohort phase of the Double Exposure study.

I-RREACH: an engagement and assessment tool for improving implementation readiness of researchers, organizations and communities in complex interventions.

BACKGROUND: Non-communicable chronic diseases are the leading causes of mortality globally, and nearly 80% of these deaths occur in low- and middle-income countries (LMICs). In high-income countries (HICs), inequitable distribution of resources affects poorer and otherwise disadvantaged groups including Aboriginal peoples. Cardiovascular mortality in high-income countries has recently begun to fall; however, these improvements are not realized among citizens in LMICs or those subgroups in high-income countries who are disadvantaged in the social determinants of health including Aboriginal people. It is critical to develop multi-faceted, affordable and realistic health interventions in collaboration with groups who experience health inequalities. Based on community-based participatory research (CBPR), we aimed to develop implementation tools to guide complex interventions to ensure that health gains can be realized in low-resource environments. METHODS: We developed the I-RREACH (Intervention and Research Readiness Engagement and Assessment of Community Health Care) tool to guide implementation of interventions in low-resource environments. We employed CBPR and a consensus methodology to (1) develop the theoretical basis of the tool and (2) to identify key implementation factor domains; then, we (3) collected participant evaluation data to validate the tool during implementation. RESULTS: The I-RREACH tool was successfully developed using a community-based consensus method and is rooted in participatory principles, equalizing the importance of the knowledge and perspectives of researchers and community stakeholders while encouraging respectful dialogue. The I-RREACH tool consists of three phases: fact finding, stakeholder dialogue and community member/patient dialogue. The evaluation for our first implementation of I-RREACH by participants was overwhelmingly positive, with 95% or more of participants indicating comfort with and support for the process and the dialogue it creates. CONCLUSIONS: The I-RREACH tool was designed to (1) pinpoint key domains required for dialogue between the community and the research team to facilitate implementation of complex health interventions and research projects and (2) to identify existing strengths and areas requiring further development for effective implementation. I-RREACH has been found to be easily adaptable to diverse geographical and cultural settings and can be further adapted to other complex interventions. Further research should include the potential use of the I-RREACH tool in the development of blue prints for scale-up of successful interventions, particularly in low-resource environments.

A novel regional citrate anticoagulation protocol for CRRT using only commercially available solutions.

PURPOSE: To describe a citrate regional anticoagulation (CRA) protocol for patients with acute renal failure and contraindications to heparin who require continuous renal replacement therapy (CRRT), using only commercially available solutions, for units that do not want or cannot prepare extemporaneously made solutions. MATERIALS AND METHODS: Case report and series from a medical/surgical intensive care unit of a university teaching hospital. A CRA protocol was developed by using only commercially available solutions. Five dialysis-specific clinical parameters were identified to allow simplified measurement and control. RESULTS: There was a dramatic improvement of dialysis filter survival in the index patient that was seen in the subsequent patients receiving CRA. This was accompanied by excellent control of the clinical and biochemical parameters as well as nursing acceptance and ownership of the protocol. CONCLUSION: It is possible to provide safe and effective CRA with only commercially available solutions. The protocol is applicable to most patients requiring CRRT.

Hypertension analysis of stress reduction using mindfulness meditation and yoga: results from the HARMONY randomized controlled trial.

BACKGROUND: The HARMONY study was a randomized, controlled trial examining the efficacy of an 8-week mindfulness-based stress reduction (MBSR) program for blood pressure (BP) lowering among unmedicated stage 1 hypertensive participants. METHODS: Participants diagnosed with stage 1 hypertension based on ambulatory BP were randomized to either immediate treatment of MBSR for 8 weeks or wait-list control. Primary outcome analysis evaluated whether change in awake and 24-hour ambulatory BP from baseline to week 12 was significantly different between the 2 groups. A within-group before and after MBSR analysis was also performed. RESULTS: The study enrolled 101 adults (38% male) with baseline average 24-hour ambulatory BP of 135±7.9/82±5.8mm Hg and daytime ambulatory BP of 140±7.7/87±6.3 mmHg. At week 12, the change from baseline in 24-hour ambulatory BP was 0.4±6.7/0.0±4.9mm Hg for the immediate intervention and 0.4±7.8/-0.4±4.6mm Hg for the wait-list control. There were no significant differences between intervention and wait-list control for all ambulatory BP parameters. The secondary within-group analysis found a small reduction in BP after MBSR compared with baseline, a finding limited to female subjects in a sex analysis. CONCLUSIONS: MBSR did not lower ambulatory BP by a statistically or clinically significant amount in untreated, stage 1 hypertensive patients when compared with a wait-list control group. It leaves untested whether MBSR might be useful for lowering BP by improving adherence in treated hypertensive participants. CLINICAL TRIALS REGISTRATION: NCT00825526.

Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial.

INTRODUCTION: Hypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives. METHODS AND ANALYSIS: Men and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) ≥135/85 mm Hg or 24 h ABP ≥130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives. ETHICS AND DISSEMINATION: This research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the summer of 2012. TRIAL REGISTRATION NUMBER: This study is registered with http://clinicaltrials.gov (NCT00825526).

The impact of endothelin-1 genetic analysis and job strain on ambulatory blood pressure.

OBJECTIVE: An interaction between the endothelin-1 gene (EDN1), blood pressure (BP) and social determinants has been previously found. Using a well-characterized cohort of participants, the impact of associations between genetic factors and job strain on BP was evaluated. METHODS: A cross-sectional analysis of five polymorphisms covering the EDN1, of which 2 were previously reported to be associated with BP, was performed. Study subjects had previously completed a baseline evaluation including 24-h ambulatory BP monitoring and an assessment of job strain. This report presents the findings for 184 subjects who gave DNA samples for genetic analysis. One-way analysis of variance (ANOVA) was performed between each genetic marker and 24-h systolic blood pressure (SBP) and diastolic blood pressure (DBP), as well as two-way ANOVAs to test the interaction effect with job strain. RESULTS: Trends for relationships were observed between SBP and two polymorphisms: rs10478694 and rs5369. An interaction between job strain and those heterozygous for two polymorphisms showed higher SBP (P=.029 and .008) and a tendency for higher DBP. All findings were more significant when analyses were confined to the 139 Caucasian subjects. CONCLUSION: This is the first study to report an interaction between the EDN1 gene, job strain and BP, supporting previous evidence of a role of this gene in the interaction between environmental stress and ambulatory BP. Given the limited sample size, the results should be considered preliminary, and further studies are required.