Digital Technology for High Blood Pressure

Recruiting at 1 trial location

Overseen By Raksha Mudar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Antihypertensives

Disqualifiers: Dementia, Assisted living, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

100 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It seems focused on helping you manage your existing high blood pressure medication better with a smartphone app.

What data supports the effectiveness of the treatment MedManage, bpMedManage-S, bpMedManage-P for high blood pressure?

Research shows that using digital tools like home blood pressure telemonitoring can significantly lower blood pressure, similar to some blood pressure medications. These tools help patients manage their condition better by regularly tracking their blood pressure and receiving guidance from healthcare professionals. ^{1 2 3 4 5}

Is the digital technology for high blood pressure safe for humans?

The research on digital technology for high blood pressure, like home blood pressure telemonitoring, shows it can help manage blood pressure effectively, but there is limited high-quality evidence on its safety. Some studies suggest it is generally safe, but more research is needed to confirm this. ^{2 3 6 7 8}

What makes the treatment MedManage unique for high blood pressure?

MedManage is unique because it uses digital technology to help patients manage their high blood pressure by allowing them to monitor their blood pressure at home and transmit the data to healthcare providers for remote decision-making. This approach supports self-management and can improve adherence to treatment, offering a novel way to manage hypertension compared to traditional in-person visits. ^{3 5 9 10 11}

Research Team

Kathleen Insel, PhD

Principal Investigator

University of Arizona

Raksha Mudar, PhD

Principal Investigator

University of Illinois, Urbana-Champaign

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.

Inclusion Criteria

TICS-M score between 27-37 and Montreal Cognitive Assessment (MoCA) score between 20-26

I am an older adult living in my own home.

Self-reported fluent in English

Exclusion Criteria

Lives in assisted living facility or skilled nursing facility

I have been diagnosed with dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments followed by 4 weeks of medication adherence monitoring

4 weeks

1 visit (in-person)

Treatment

Participants are randomized into one of two treatment arms and receive intervention for medication adherence

4 weeks

1 visit (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• MedManage

Trial Overview 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).

Participant Groups

Group I: bpMedManage-S Experimental Treatment 1 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-P Active Control 1 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.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

University of Illinois at Urbana-Champaign

Collaborator

Trials

203

Recruited

40,600+

Findings from Research

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

Blood pressure (BP) telemonitoring significantly reduces both systolic BP (by 3.9 to 13.0 mm Hg) and diastolic BP (by 2.0 to 8.0 mm Hg), showing effects comparable to some antihypertensive medications, based on a review of 15 studies.

While BP control was the main focus, the evidence for BP telemonitoring's impact on secondary outcomes like healthcare utilization and costs was less conclusive, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. AbuDagga, A., Resnick, HE., Alwan, M.[2010]

Home blood pressure telemonitoring (HBPT) has been shown to improve patient compliance and hypertension control rates, based on randomized controlled trials, although the overall evidence for blood pressure reduction is considered 'moderate'.

Despite the potential of digital health interventions, there is a lack of high-quality evidence regarding the accuracy and safety of mobile applications for hypertension management, indicating that not all available apps are suitable for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. Postel-Vinay, N., Bobrie, G., Asmar, R., et al.[2023]

In a study of 156 patients with uncontrolled hypertension using a home-based digital-medicine program, 71% achieved target blood pressure control after 90 days, compared to only 31% in a usual-care group.

The digital-medicine approach not only significantly reduced blood pressure (average decrease of 14/5 mm Hg) but also led to a substantial decrease in excess sodium consumption and improved patient engagement, indicating its effectiveness and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Hypertension Control and Patient Engagement Using Digital Tools. Milani, RV., Lavie, CJ., Bober, RM., et al.[2017]

Blood pressure telemonitoring (BPT) has been shown to significantly reduce blood pressure in high-risk hypertensive patients compared to usual care, especially when supervised by healthcare professionals.

Mobile health (m-health) solutions, including health tracking apps, empower patients to manage their hypertension more actively, enhancing their involvement in medical decision-making and potentially improving overall care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. Omboni, S., Caserini, M., Coronetti, C.[2018]

In a study of 53 patients with uncontrolled hypertension, treatment with olmesartan medoxomil for 12 weeks resulted in significant reductions in both office and self-measured blood pressure, with 64.2% of patients achieving normalized blood pressure based on office measurements.

Telemonitoring of blood pressure self-measurements allowed for earlier identification of treatment responders, although overall compliance was affected by patient adherence, highlighting the importance of monitoring methods in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring of blood pressure self measurement in the OLMETEL study. Mengden, T., Ewald, S., Kaufmann, S., et al.[2019]

Home blood pressure monitoring (HBPM) can improve medication adherence, with 6 out of 11 randomized controlled trials showing significant improvements, especially when combined with other strategies like patient counseling and education.

Interventions in primary care settings were less effective than those in hospital or nonclinical settings, indicating that the environment may play a crucial role in the success of HBPM on medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of home blood pressure monitoring on medication adherence. Ogedegbe, G., Schoenthaler, A.[2022]

Home blood pressure telemonitoring can significantly improve blood pressure control and reduce hypertension when combined with structured case management, but it is not widely adopted in Canada due to various barriers.

Key challenges to implementing home BP telemonitoring include the need for better infrastructure, user-friendly technology, data security, and appropriate reimbursement models for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Telemonitoring: Rationale for Use, Required Elements, and Barriers to Implementation in Canada. Wood, PW., Boulanger, P., Padwal, RS.[2018]

Digital health management, particularly through telemonitoring, is a promising approach for managing hypertension, a common condition that often goes undercontrolled, as it allows for effective monitoring without the need for frequent office visits.

While further clinical trials are needed to confirm the safety and efficacy of these technologies, the integration of internet-based care for hypertension is essential for improving public health and addressing the challenges of managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state and future of internet technology-based hypertension management in Japan. Yatabe, J., Yatabe, MS., Ichihara, A.[2022]

A digital hypertension self-management program significantly reduced systolic blood pressure (SBP) by an average of 4.8 mm Hg over 12 months for all participants, and by 8.1 mm Hg for those with uncontrolled SBP at baseline, indicating its efficacy in managing hypertension.

Participants with uncontrolled SBP also experienced notable improvements in diastolic blood pressure, weight loss (average of 6.5 lbs), and body mass index (BMI), demonstrating the program's comprehensive impact on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. Wu, J., Napoleone, J., Linke, S., et al.[2023]

The TASMINH4 trial, involving 40 participants (23 patients and 15 healthcare professionals), highlighted that both self-monitoring and telemonitoring of blood pressure are acceptable to patients and healthcare providers, with telemonitoring enhancing communication between them.

While telemonitoring using mobile health solutions offers convenience and faster communication, traditional paper-based self-monitoring fits more easily into existing healthcare workflows, suggesting that both methods should be available to patients for effective hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using mHealth for the management of hypertension in UK primary care: an embedded qualitative study of the TASMINH4 randomised controlled trial. Grant, S., Hodgkinson, J., Schwartz, C., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. [2010]

3. China pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Improving Hypertension Control and Patient Engagement Using Digital Tools. [2017]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Telemedicine and M-Health in Hypertension Management: Technologies, Applications and Clinical Evidence. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Telemonitoring of blood pressure self measurement in the OLMETEL study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of home blood pressure monitoring on medication adherence. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Telemonitoring: Rationale for Use, Required Elements, and Barriers to Implementation in Canada. [2018]

9. England pubmed.ncbi.nlm.nih.gov

The current state and future of internet technology-based hypertension management in Japan. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Long-Term Results of a Digital Hypertension Self-Management Program: Retrospective Cohort Study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Using mHealth for the management of hypertension in UK primary care: an embedded qualitative study of the TASMINH4 randomised controlled trial. [2021]