Digital Technology for High Blood Pressure
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arizona
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention.
Is MedManage a promising treatment for high blood pressure?Yes, MedManage is a promising treatment for high blood pressure. It uses digital technology to help people monitor their blood pressure at home and share this information with their doctors. This can lead to better control of blood pressure and improve overall health. Digital tools like MedManage can make it easier for patients to manage their condition and stay involved in their healthcare.5891011
Do I have to stop taking my current medications for this trial?The trial does not specify if you need to stop taking your current medications. However, since the study focuses on improving adherence to antihypertensive medications, it is likely that you will continue taking them.
What safety data exists for the digital treatment of high blood pressure?The safety data for digital treatments like MedManage, bpMedManage-S, and bpMedManage-P, which involve home blood pressure telemonitoring, is not explicitly detailed in the provided research. However, studies indicate that telemonitoring can improve blood pressure control and medication adherence, suggesting a positive impact on treatment outcomes. The evidence for its effectiveness is moderate, and while it shows potential, high-quality evidence on the overall safety and effect of smartphone apps on blood pressure control is still lacking. Compliance among patients is generally favorable, but more data is needed on healthcare provider compliance and the independent effects of these interventions in primary care settings.123710
What data supports the idea that Digital Technology for High Blood Pressure (also known as: MedManage, bpMedManage-S, bpMedManage-P) is an effective treatment?The available research shows that using digital technology for high blood pressure, like home blood pressure telemonitoring, can effectively lower blood pressure. One study found that patients using digital tools had a significant drop in blood pressure, with 71% reaching their target levels compared to only 31% in the usual care group. Another study noted that blood pressure telemonitoring led to reductions in blood pressure similar to those seen with some blood pressure medications. These findings suggest that digital technology can be a powerful tool in managing high blood pressure, often performing better than traditional methods.345610
Eligibility Criteria
This trial is for older adults with mild cognitive impairment (MCI) who also have high blood pressure. Participants should be able to use a smartphone and willing to be monitored for their medication adherence over 16 weeks.Participant Groups
The MedManage study tests a smartphone app designed to help manage hypertension medications. There are two groups: one uses the app with reminders and education (MedManage-S), while the other receives only educational information (MedManage-P).
2Treatment groups
Experimental Treatment
Active Control
Group I: bpMedManage-SExperimental Treatment1 Intervention
Intervention group will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention.
Group II: bpMedManage-PActive Control1 Intervention
Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on the education portal. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Illinois, Urbana-ChampaignChampaign, IL
University of ArizonaTucson, AZ
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Who is running the clinical trial?
University of ArizonaLead Sponsor
University of Illinois at Urbana-ChampaignCollaborator
References
Telemonitoring of blood pressure self measurement in the OLMETEL study. [2019]To investigate the feasibility of blood pressure (BP) telemonitoring in previous uncontrolled hypertensives treated with olmesartan medoxomil in a clinical practice setting.
A systematic review of the effects of home blood pressure monitoring on medication adherence. [2022]Home blood pressure monitoring (HBPM) improves blood pressure control, but little is known about its effects on medication adherence. The authors conducted a systematic review of the published literature on the effects of HBPM on medication adherence. Of 440 abstracts and citations reviewed, 11 randomized control trials met predefined criteria. Six of the 11 randomized controlled trials reported statistically significant improvement in medication adherence; 84% of these were complex interventions involving the use of HBPM in combination with other adherence-enhancing strategies such as patient counseling by nurses, pharmacists, or a telephone-linked system; patient education; and the use of timed medication reminders. Interventions conducted in primary care settings were not effective compared with those that occurred in hospital-based clinics or nonclinical settings. The data on the effects of HBPM on patients' medication-taking behavior are mixed. Future studies should investigate the independent effects of HBPM in primary care practices where the majority of hypertensive patients receive their care.
Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. [2010]We searched five databases (PubMed, CINAHL, PsycINFO, EMBASE, and ProQuest) from 1995 to September 2009 to collect evidence on the impact of blood pressure (BP) telemonitoring on BP control and other outcomes in telemonitoring studies targeting patients with hypertension as a primary diagnosis. Fifteen articles met our review criteria. We found that BP telemonitoring resulted in reduction of BP in all but two studies; systolic BP declined by 3.9 to 13.0 mm Hg and diastolic BP declined by 2.0 to 8.0 mm Hg across these studies. These magnitudes of effect are comparable to those observed in efficacy trials of some antihypertensive drugs. Although BP control was the primary outcome of these studies, some included secondary outcomes such as healthcare utilization and cost. Evidence of the benefits of BP telemonitoring on these secondary outcomes is less robust. Compliance with BP telemonitoring among patients was favorable, but compliance among participating healthcare providers was not well documented. The potential role of BP telemonitoring in the reduction of BP is discussed and suggestions on priority populations that can benefit from this technology are presented.
Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]To systematically review data from randomized controlled studies on the effectiveness of home blood pressure telemonitoring (HBPT) versus usual care with respect to improvement of BP control, healthcare resources utilization and costs, patient's quality of life and adverse events.
Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. [2018]Electronic processes and communication technologies are more and more often employed to provide healthcare services to caregivers and their patients. Such solutions are currently referred as e-health, the most popular and widely distributed being those based on telemedicine and mobile health (m-health). A specific application of telemedicine for hypertension management is blood pressure telemonitoring (BPT), which allows remote data transmission of BP and additional information on patients' health status from their living site or from a community setting to the doctor's office or the hospital. Several randomized studies have documented a significant BP reduction with regular BPT compared to usual care, particularly in high risk hypertensive patients. Additional benefits are observed when BPT is offered under the supervision of a team of healthcare professionals, including a community pharmacist. BPT may also be provided in the context of m-health solutions, which commonly include wireless diagnostic and clinical decision support tools. M-health has the potential to promote patient's self-management, as a complement to the doctor's intervention, and encourage greater participation in medical decision making. Current statistics show that half of smartphone owners gather health information through their phone and 19 % use a health app. In case of hypertensive patients the most popular apps are those with tracking function, including BPT. Thus, e-health, and in particular BPT and m-health, are progressively gaining a key role in the management of hypertensive patients, having the potential to improve the quality of the delivered care and to more effectively prevent cardiovascular consequences of high BP.
Improving Hypertension Control and Patient Engagement Using Digital Tools. [2017]Hypertension is present in 30% of the adult US population and is a major contributor to cardiovascular disease. The established office-based approach yields only 50% blood pressure control rates and low levels of patient engagement. Available home technology now provides accurate, reliable data that can be transmitted directly to the electronic medical record. We evaluated blood pressure control in 156 patients with uncontrolled hypertension enrolled into a home-based digital-medicine blood pressure program and compared them with 400 patients (matched to age, sex, body mass index, and blood pressure) in a usual-care group after 90 days. Digital-medicine patients completed questionnaires online, were asked to submit at least one blood pressure reading/week, and received medication management and lifestyle recommendations via a clinical pharmacist and a health coach. Blood pressure units were commercially available that transmitted data directly to the electronic medical record. Digital-medicine patients averaged 4.2 blood pressure readings per week. At 90 days, 71% of digital-medicine vs 31% of usual-care patients had achieved target blood pressure control. Mean decrease in systolic/diastolic blood pressure was 14/5 mm Hg in digital medicine, vs 4/2 mm Hg in usual care (P
Home Blood Pressure Telemonitoring: Rationale for Use, Required Elements, and Barriers to Implementation in Canada. [2018]Contemporary hypertension guidelines strongly endorse the use of home blood pressure (BP) monitoring for hypertension diagnosis and management. However, barriers exist that prevent optimal use of home BP measurements. Patients might not follow the recommended home BP measurement protocol, might not take the required number of readings, and/or might report only selected readings to their providers. Providers might not calculate the mean (used for clinical decision-making) and/or incorporate home BP measurements into the medical record. Use of home BP telemonitoring, defined as the process by which home BP readings are securely teletransmitted and summarized within a health care portal or electronic medical record for provider use, might overcome these barriers. Telemonitoring, especially when combined with protocolized case management, leads to statistically significant and clinically important BP reductions, and improvements in overall BP control. Despite evidence supporting its use, home BP telemonitoring is not widely used in Canada. Barriers to adoption can be classified as structural and financial. Although technological advancements have made telemonitoring highly feasible, infrastructure is lacking, and implementation remains a challenge; this is especially true with respect to creating simple and cost-effective systems that are user-friendly and acceptable to patients as well as to providers. Ensuring data security is crucial to successful implementation, as is developing appropriate reimbursement models for providers. If these barriers can be overcome, home BP telemonitoring has the potential to make care provision easier and more convenient for patients and providers, while improving BP control in Canadians with hypertension.
Using mHealth for the management of hypertension in UK primary care: an embedded qualitative study of the TASMINH4 randomised controlled trial. [2021]Self-monitoring of blood pressure is common but how telemonitoring with a mobile healthcare (mHealth) solution in the management of hypertension can be implemented by patients and healthcare professionals (HCPs) is currently unclear.
The current state and future of internet technology-based hypertension management in Japan. [2022]Internet-based information and communication technology is altering our lives. Although medicine is traditionally conservative, it can benefit in many ways from adopting new technology and styles of care. Hypertension is a prime condition for the practical application of digital health management because it is prevalent and undercontrolled, and its primary index, home blood pressure, can be effectively telemonitored. Compared to other conditions that require laboratory measures or the use of drugs with frequent side effects, hypertension can be managed without actual office visits with sufficiently low risk. In this review of hypertension in Japan, we discuss the current and somewhat fragmented state of internet technology and the components and processes necessary for smooth, integrated, and multidisciplinary care in the future. Although further clinical trials are required to show the safety and efficacy of information and communication technology-based care for hypertension, the deployment of telemonitoring and telemedicine in daily practice should be expedited to solve the hypertension paradox. Challenges remain relating to cost, data integration, the redesigning of team-based care, and the improvement of user experience, but information and communication technology-based hypertension management is sure to become pivotal in improving public health.
Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. [2023]The development of mobile telephones has made it possible to design blood pressure (BP) monitors with data transmission via cellular lines, contributing to the emergence of "e-health". Today, the direct-to-consumer marketing of devices create a new context allowing an algorithmic processing of information for remote decision-making either by the patient or by a healthcare professional. The home BP telemonitoring (HBPT) is the remote transmission of BP values, measured at home and transmitted to the doctor's office or hospital, by means of telehealth strategies. In this context, randomized controlled trials (RCTs) studies have demonstrated HBPT ability in improving patients' compliance and adherence to treatment and in accomplishing better hypertension control rates. The level of evidence for the drop in BP is "moderate" and the place of HBPT is not clearly established in current practice. Digital interventions have the potential to support patient in self-management. This approach presupposes the prior acquisition of skills, the level of which must be adapted to the level of health literacy of each patient. Few of medical applications (mobile apps or web-apps) for hypertension can be regarded as accurate and safe for clinical use and to date, we do not have high quality evidence to determine the overall effect of the use smartphone apps on BP control.
Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. [2023]Digital health programs that incorporate frequent blood pressure (BP) self-monitoring and support for behavior change offer a scalable solution for hypertension management.