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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called MedManage, designed to help individuals adhere to their high blood pressure medication routine. It involves two groups: one uses the app with medication reminders and educational information, while the other receives only the educational information. The goal is to determine if the app can improve medication habits for older adults who sometimes struggle with memory or focus. Ideal participants are older adults who manage their own blood pressure medications, occasionally face memory challenges, and regularly use a smartphone.

As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for medication management.

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 prior data suggests that this smartphone technology is safe for improving medication adherence in older adults with mild cognitive impairment?

Research has shown that using smartphone apps for health management is generally safe and easy to handle. Participants have found bpMedManage's digital tools simple and helpful. No serious problems have been reported with these apps, which primarily remind users to take their medication and provide health information. Since these apps don't involve taking drugs or undergoing medical procedures, they are considered low-risk. The main goal is to help users better manage their high blood pressure by adhering to their medication schedules. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the bpMedManage treatments because they leverage digital technology to tackle high blood pressure in a new way. Unlike traditional treatments that rely solely on medications like ACE inhibitors or beta-blockers, bpMedManage uses a smartphone app to enhance patient engagement and adherence. The bpMedManage-S arm is particularly innovative, as it combines medication reminders with educational content, potentially improving how patients manage their hypertension daily. This approach could lead to better outcomes by making it easier for patients to stick to their treatment plans and understand their condition.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Studies have shown that smartphone apps can help people manage high blood pressure effectively. Research indicates that using a smartphone app with medication reminders and educational content improves adherence to medication schedules. This adherence is crucial for better blood pressure control. Users of similar apps have reported improved management of their condition, successfully keeping their blood pressure in check. In this trial, participants in the bpMedManage-S group will receive medication reminders, potentially enhancing effectiveness compared to providing education alone, as seen in the bpMedManage-P group. ^{1 3 6 7 8}

Who Is on the Research Team?

Raksha Mudar, PhD

Principal Investigator

University of Illinois, Urbana-Champaign

Kathleen Insel, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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 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]

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]

Citations

1. ctv.veeva.com ctv.veeva.com/study/medmanage-digital-technology-to-support-adherence-to-hypertension-medications

bpMedManage: Digital Technology to Support Adherence to ... The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8223338/

The effect of the mobile “blood pressure management ... Many studies have investigated the effectiveness of utilizing smartphone applications, and most of them have reported desirable effectiveness [16–18].

3. withpower.com withpower.com/trial/phase-mild-cognitive-impairment-mci-1-2024-dff5f

Digital Technology for High Blood Pressure The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence ...

4. nature.com nature.com/articles/s41440-023-01516-3

The effects of smartphone apps expected in self ... The effects of smartphone apps expected in self-management for hypertension management. Yoichi Nozato & Hypertension Research volume 47, pages 564–565 (2024)

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10485713/

Long-Term Results of a Digital Hypertension Self ... This study provides real-world evidence that a comprehensive digital health program involving hypertension education, at-home BP monitoring, and behavior ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06307574/bpmedmanage-digital-technology-to-support-adherence-to-hypertension-medications?state=AZ&city=Tuscon

bpMedManage: Digital Technology to Support Adherence ... The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure ...

7. researchgate.net researchgate.net/publication/396775297_A_qualitative_study_to_refine_and_finalize_the_MedManageSCI_prototype_A_web-based_toolkit_to_support_medication_self-management_in_adults_with_spinal_cord_injurydysfunction

(PDF) A qualitative study to refine and finalize the ... Overall, participants found the modules to be comprehensive and highly relevant. Further, we discuss the application of cognitive interviews for ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/74/NCT06307574/Prot_000.pdf

PROTOCOL Along with the outcome measures, hypertension knowledge. (HKLS) will be measured. Research staff will collect medication adherence data via the ...