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BP-HOME Monitor

Blood Pressure-HOME Monitoring Intervention Trial and Outcomes Research

 

The BH-Home Monitor project aims to assess the barriers, facilitators and context for home blood pressure (BP) management in low- and middle-income countries.

The BP-HOME Monitor team

Ambuj Roy MD, DM

Email: drambujroy@gmail.com

 

Ambuj is interested in cardiovascular epidemiology and clinical trials. His research interest includes strengthening evidence-based secondary prevention strategies and finding low-cost solutions for cardiovascular interventions in the community in developing countries. In this context, he has been the centre Principal Investigator of the UMPIRE Trial; which demonstrated that the polypill helps in improving compliance for secondary prevention; and also in the ongoing Yoga-Care Trial which envisages the use of Yoga based cardiac rehabilitation. He has been earlier involved as a co-investigator in large multi-national studies like INTERHEART study, STICH Trial, FREEDOM Trial, CREATE Registry and ALTITUDE Diabetes study. In addition, he has a keen interest in cardiovascular epidemiology and is one of the lead investigators of a large study assessing the prevalence of coronary artery disease and its risk factors in urban and rural areas of Delhi and studying their secular trends. He is also the national Principal Investigator for the INTERCHF study, a large international registry of patients of congestive heart failure.

Anastase Dzudie MD

Email: aitdzudie@yahoo.com

 

Anastase received his training in general medicine and internal medicine at the school of medicine of the Yaounde 1 University in his home country, before receiving further training in cardiovascular medicine at the Claude Bernard University in Lyon (France) where he acquired competence in cardiac pacing, cardiac and vascular ultrasound, and sports cardiology. He was laureate of the twin center fellowship of the World heart federation and is currently a fellow of the European Society of Cardiology, the Scientific Secretary of the Cameroon Cardiac Society, chair of the task force on hypertension of the Pan-African Society of Cardiology, Regional Editor of the Cardiovascular Journal of Africa and editorial board member for Tropical cardiology. He has co-authored over 40 peer-reviewed publications and participated in a number of multicentric and international studies including THESUS-HF, RELY AF, PAPUCO I and II, and EIGHT. His current research focus includes systemic hypertension, heart failure and pulmonary hypertension.

Cheryl Anderson PhD, MS, MPH

Email: c1anderson@ucsd.edu

 

Cheryl is an Associate Professor of Preventive Medicine at the University of California San Diego (UCSD) School of Medicine. Her research focuses on diet and the prevention of cardiovascular disease, and she is an active researcher in cardiovascular epidemiology and has been an investigator on several observational epidemiologic studies and clinical trials. She is an active mentor and teacher and served as the Director of the Bachelor of Science in Public Health program at UCSD from 2012-2014. Dr. Anderson is a Fellow of the American Heart Association where she serves on the leadership committees for the Epidemiology and Prevention Council and the Cardiometabolic Health and Lifestyle Council. She is also a member of the AHA’s National Research Committee. Dr. Anderson’s honors include the Gil Omenn Award for Academic Excellence, Dannon Nutrition Leadership Scholar, and a Volunteer Service Award from the National Kidney Foundation.

Deepak Kamath MD, MBBS

Email: kamath.deepak@sjri.res.in

 

Deepak’s areas of research interest are in the epidemiology, prevention, task-shifting and implementation research pertaining to Non-Communicable Diseases (NCD), particularly cardiovascular disease (CVD). He researched medication adherence patterns and its determinants among heart failure patients as part of his M.D. dissertation. He has worked as a project officer for the  NHLBI funded SPREAD study that aimed to improve adherence to medications and lifestyle modification in patients post-Acute Coronary Syndromes using trained non-physician health workers. In this capacity, he had a key role developing the protocol and health worker training modules, training health workers, developing tools to improve patients’ medication adherence, developing data collection tools and coordinating the study. He is a co-investigator on the UK – Medical Research Council-funded pilot project evaluating the feasibility of using trained peer mentors for CVD risk factor control at worksites in 3 South Asian countries (Bangladesh, Sri Lanka and India). He is also a project officer for a large NHLBI funded nationwide stroke registry and several large primary CVD prevention trials.

Namratha Kandula MD, MPH

Email: nkandula@nmff.org

 

Nammi is a primary care physician and researcher with a long-standing commitment to improving health and health care in communities that are affected by social inequality. In her current faculty position at Northwestern University, she leads research funded by the National Institutes of Health, on cardiovascular disease prevention in South Asian immigrants.  Her research is shaped by two common and related aims:

1. Investigating the determinants of cardiovascular disease disparities using methods from epidemiology, health service research, and social sciences.

2. Using community-engaged research methods to develop patient-centered cardiovascular disease prevention interventions for minority communities. The goal of her research is to ensure that minority communities benefit from biomedical research by moving scientific knowledge into action by explicitly integrating the patient perspective and the social and cultural context of health into cardiovascular disease prevention.

Rafael Vidal Perez MD, PhD

Email: rafael.vidalperez@gmail.com

 

Rafael is a Cardiologist from Lugo, Spain. He studied Medicine at Universidad de Santiago de Compostela. In 2008 he specialized in Cardiology at Clínico Universitario de Santiago de Compostela, Spain. He is an active member of the Spanish Society of Cardiology in his web committee and former secretary of Cardiology Specialists in Training Council of Spanish Cardiology Society. He is also an active participant in the European Society of Cardiology (ESC) as Fellow and former nucleus of ESC Cardiologists of Tomorrow. His main field of research is cardiovascular risk factors and primary care and also topics like chronic ischaemic heart disease, diabetes, heart failure. During these last years, he was particularly involved in the management of observational studies at a regional level with primary physicians and has published national and international peer-review academic papers in relation to these studies (http://www.researcherid.com/rid/B-5448-2012) and also his PhD dissertation was based in this research. Rafael believes in the usefulness of multinational studies.

Sheikh Mohammed Shariful Islam MBBS, MPH, MHR

Email: shariful.islam@icddrb.org

 

Shariful Islam has previously worked as a Team Leader and Medical  Officer in UNDP Bangladesh, International Health Advisor, WHO, Project Officer, GiZ and Clinical Trial Physician, Texas Tech University, Lubbock, USA. His main areas of research are non-communicable diseases (NCDS), in particular, diabetes and cardiovascular diseases, cardiovascular diabetology, hypertension, economic evaluations of NCDs, clinical epidemiology and health systems for NCDs. He is the Principal Investigator on a number of research grants and has published several peer-reviewed scientific papers in international journals. He has more than 50 scientific presentations in international conferences, organized and served as chair in several global health conferences. He has received several national and international awards, including a gold medal for academic excellence, Fogarty Fellowship, WHO Fellowship, Packard Award and DAAD Fellowship. Dr. Islam is a member of the editorial board of the British Journal of Medical Practitioners and WHO Bulletin.

Syed Shah MD, MPH, PhD

Email: syeds@uaeu.ac.ae

 

Syed Shah is a physician specialized in community medicine and Associate Professor at the Institute of Public Health, College of Medicine and Health Sciences at United Arab Emirates University in Al Ain, Abu Dhabi. He completed his medical training in his home country of Pakistan and MPH in international health and PhD in Epidemiology from the School of Public Health, Health Sciences Center at Houston, University of Texas, USA. He was selected for Global Clinical Scholars Research Training Program, and completed a one-year certification course on clinical trials from Harvard Medical School. Prior to his current work, he contributed in public health practice, research and teaching in the Department of Community Health Sciences at the Aga Khan University in Karachi, Pakistan, during 1990-1998, in Health and Safety Program, in Olympia, Washington State Government, USA, in 2001-2004, and in the Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Canada in 2004-2008. He is conducting community-based CVD prevention research in the United Arab Emirates and in low-resource settings. He is one of the WHO nominated NCD Surveillance Specialist for countries in EMRO region.

Specific aims

  1. To assess the barriers, facilitators and context for home blood pressure (BP) management in low- and middle-income countries. Hypothesis: There will be unique contextual factors that will inform the design of a clinical trial of home blood pressure management in low- and middle-income countries.
  2. To conduct a process evaluation to explore intervention feasibility and acceptability.
  3. To beta test home blood pressure monitors and titration protocols and materials.

Background

Control of hypertension in low- and middle-income countries is poor. It has been documented that home blood pressure management significantly lowers blood pressure (BP) when compared to usual care in high-income countries. In a high-income country, one study of home blood pressure management (n=527) showed, at 6 months after the intervention, a decrease in systolic blood pressure (SBP) 12.9 (95%CI 10.4-15.5) in self-management group vs. 9.2 mmHg (95%CI 6.7-11.8) in control group. The decrease in SBP was even higher at 12 months after intervention: 17.6 mmHg (95%CI 14.9-20.3) and 12.2 mmHg (95%CI 9.4-14.9), respectively. This strategy for blood pressure measurement has been incorporated into NICE guidelines in the United Kingdom. As such, our research question is relevant to public health efforts and clinical practice.

Recent data suggests that the utility of home blood pressure monitors may be limited in resource-restricted settings in the US. However, there is limited data from low- and middle-income countries. One recent clinical trial in Mexico and Honduras documented that individuals using a BP monitor combined with automated interactive voice response messages, had SBP levels 4.2 mmHg (95%CI -9.1, 0.7; p=0.09) lower on average than the control group. Furthermore, a subgroup of individuals with low literacy showed a higher decrease, 8.8 mmHg (95%CI -14.2, -3.4; p=0.002). However, this study had important limitations such as short duration of follow up, a small sample (n=181), and limited interface with the health care system.

The potential impact of this work is high because of the high global burden of hypertension in low- and middle- income countries; thereby, the identification of innovative and effective strategies to control blood pressure is critical. To the best of our knowledge, our study aims to be one of the first to provide evidence of the feasibility and utility of home blood pressure management to optimize blood pressure management in these settings. Figure 1 shows our conceptual framework for the relationships between home blood pressure management context and blood pressure. We hypothesize that self-management will optimize the management of blood pressure in a low-income setting by reducing delays in medication titration and improving adherence to antihypertensive medication.

There are important implications of this work regardless of whether the findings are negative or positive. A positive result provides much-needed information about the feasibility and possible importance of dose titration, and the role of home blood pressure monitors in accomplishments. A negative result will provide information about the barriers and facilitators of self-management in the low- and middle-income study.

Methodology

Aim 1

We will conduct mixed-methods, implementation science study in adults with uncontrolled high blood pressure, living in low- and middle-income countries. First, we will conduct a qualitative study, followed by a pragmatic, pilot, clinic-based, unblinded, randomized controlled trial of home blood pressure management. Next, we will conduct a qualitative study of participant and health care team perceptions about the intervention and implementation process.

For the in-depth semi-structured interviews and focus group discussions, we will include 24 patients, 12 family caregivers, and 12 stakeholders at each of the 5 sites. For the usability testing of monitors and protocols, we will include 10 patients and their family caregivers and health care teams at each of the 5 sites. Sampling will be purposive and heterogeneous to capture individuals with family caregivers and those without, and those with longer-standing hypertension (≥3years) and those with a newer diagnosis (< 3years). Study participants will be selected through two stages. In the first stage, outpatient medical clinics will be selected in each city: 1) Gilgit, Pakistan, 2) Delhi, India (North), 3) Bangalore, India (South), 4) Dhaka, Bangladesh, and 5) Douala, Cameroon. Patients from the practices that fall under the inclusion criteria will be invited to participate in the study. Key informants from the health care teams and health care systems will be invited through local contacts.

Interviews and focus group discussions. Health care worker, patient, and family caregiver perspectives will be obtained using two qualitative research techniques: in-depth semi-structured interviews and focus group discussions. At least two discussion groups of patients with their family caregivers (n=10-12 participants in each group) will be formed in each city. Individual interviews will be conducted with key informants from the health care systems, including primary care physicians and cardiologists, nurses, community health workers, and administrators. A focus group discussion guide will be developed collaboratively using literature review, expert input, and local team input. Key informant interviews will use a semi-structured interview guide developed with the same process. The interview guide will be designed to assess whether the health system will be stressed by our intervention. Guides and protocols will be standardized across sites to ensure cross-national comparisons of qualitative data and data collection will be conducted by individuals trained in conducting qualitative methods. The broad themes that will be examined in our qualitative study are summarized in Figure 1. They include barriers and facilitators to home blood pressure management in low- and middle-income countries. We are interested in factors that may occur on the individual level (e.g., family structure, duration of hypertension, age, access to healthcare) and the provider level (e.g., clinical inertia, practice size, age).

Beta testing of home BP monitors and titration protocols and materials. The study team and local teams will adapt titration protocols and patient materials (such as BP diaries) from prior trials of home BP management so that they are culturally and contextually appropriate. We will choose 5 patients (at least 2 of them will have a family caregiver) at the trial site who meet study inclusion criteria to beta-test the home BP monitor. Clinic staff will be asked to identify 5 patients and their caregivers for this part of the study. Patients and caregivers will be trained and instructed to use the monitors for one week and to record readings. Research staff will observe the participant in the home and use a checklist to document the process. At the end of the week, we will also ask participants for feedback on the experience, and how it could be made better. We will also ask physicians, nurses, community health workers and patients and family caregivers for feedback on the titration protocols and materials. We will have five patients and family caregivers use the titration protocol to determine barriers, facilitators and fidelity to the protocol. We are specifically interested in the appropriateness of the frequency of medication titration, clarity and literacy-appropriateness of instructions, and comfort level of the health care team and patient/family caregiver with the actions recommended. We will use standardize checklists and interviews to obtain information from beta-testing.

Practice assessment survey. Clinic sites will be asked to complete a practice survey assessment that will collaboratively be adapted for local use and will be used to identify the strengths and weaknesses of the practice for carrying out quality improvement efforts in BP management.

Aim 2

Study participants will be recruited from medical (out-patient) clinics in a low- income/ low-middle income country (detailed methods described elsewhere). The intervention group (self-management) will consist of self-monitoring of BP with self-titration of medication following a predetermined three-step algorithm dependent on the self-monitored BP readings. Participants will receive a home blood pressure monitor and a self-titration plan. They will be trained by designated clinic staff. Participants will be given diaries for the recording of readings, and instructions about the frequency of measurement and recording blood pressure. As in the TASMIN-SR protocol, each patient in the intervention group will be given an individually tailored three-step algorithm through which to adjust medication according to measured BP. Each step will represent a single medication change (additional medication or increased dose) that will be made at the end of the measurement week. Of note: the qualitative study will be used to inform the acceptability and timing of the three-step titration. Medication choice for the self-titration plan will be ratified by the primary physician who will be provided with an algorithm based on clinical guidelines for hypertension. If patients use all three steps of their management plan they will return to their primary care physician and an additional three-step plan will be devised. Medications will not be provided as part of the intervention. Medication procurement in each specific site will be studied as part of Aim 1 and will be documented for participants in both arms of Aim 2.

The control group (usual care) will consist of the participant seeing a designated member of the health care team for routine BP measurement and/or adjustment of medication at the discretion of the health professional.

Aim 3

At the completion of Aim 2, we will recruit a purposive sample of intervention participants (e.g., various ages, sexes, level of fidelity), family caregivers who may have been involved in the HBPM, and a designee from each of the health care teams. We will conduct exploratory qualitative research to understand acceptability, fidelity, satisfaction, challenges, and benefits of the home BP management intervention. Information from this phase of the study will be used to modify and adapt the intervention and trial design for a larger-scale implementation trial in different LMIC settings.

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