Blood Pressure-Improving Control Among Alaska Native People" (BP-ICAN) (CHAR2)

May 9, 2022 updated by: Denise Dillard, Southcentral Foundation

Home Blood Pressure Monitoring Intervention for Self-Management of High Blood Pressure Among Alaska Native People

The investigators have designed a group randomized, multi-level, sustainable stroke and cardiovascular disease (CVD) prevention trial - "Blood Pressure: Improving Control among Alaska Native People" (BP-ICAN) - that targets blood pressure control among Alaska Native and American Indian people diagnosed with hypertension. Washington State University will assist with design, provides general scientific and clinical consulting, will help guide implementation and conduct statistical analyses. The purpose of the study is to see if monitoring blood pressure at home improves the management of hypertension.

Participants will include adults who have a diagnosis of hypertension and have not achieved blood pressure control. During the pandemic, blood pressure control will be assessed during a week long study of home blood pressure readings. This study will include both a control arm (treatment as usual) and an intervention arm. Primary Care Center (PCC) provider teams and associated panels of Alaska Native or American Indian (ANAI) adults will be randomized into the control or intervention arm. The investigators will recruit up to 10 ANAI adults per PCC provider for a total of 324 participants.

Intervention participants will receive a home blood pressure monitor (HBPM), upload personal home blood pressure values into a data mall, and be encouraged to communicate with providers and pharmacists about HBPM results using an online electronic health record application, telephone, or other existing clinical processes. HBPM measurements for each intervention arm participant will be provided to provider teams and integrated pharmacists. Control participants will receive care as usual.

The investigators will collect data from study participants in both the intervention and control arms over a 12 month period. Participants will meet with investigators at time of consent (baseline), and 3, 6, and 12 months after baseline. At each visit, participants will have blood pressure measured using 3 methods (aneroid sphygmomanometer, automated Omron upper arm cuff device, and automated Omron wrist cuff device), complete surveys, and have height, weight, and arm circumference measured. In-person measures are omitted during the pandemic and only one method of blood pressure measurement is used (upper arm cuff device). Clinical and service utilization information will be electronically queried with participant consent.

The investigators will examine whether participants in the intervention arm have better blood pressure control at the end of the 12 month period than participants in the control arm.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Cardiovascular disease (CVD) and stroke have become leading causes of mortality among ANAI people, who experience CVD disparities in incidence, risk factors, and mortality, especially for stroke, compared to the general population. From 1994-2003 stroke mortality in ANAIs was at least 25% higher than for Whites in Alaska. Over the same period, stroke mortality for ANAIs under age 45 increased 400%, but declined in Whites. In addition, the decline in age-adjusted CVD mortality observed in recent decades within the general population does not extend to ANAIs. Controlling hypertension is a pillar of prevention for CVD and stroke.

Although ANAIs were formerly thought to have a very low prevalence of stroke and CVD, more reliable newer data indicate high levels of hypertension and associated mortality. A recent systematic review of 141 publications on hypertension in ANAI people documented a significant increase in recorded prevalence over the past 3 decades, as well as a significantly higher prevalence in ANAI adults than in reference populations, usually White. Aggregated data from the Behavioral Risk Factor Surveillance System (BRFSS) also show a higher prevalence of self-reported hypertension in ANAIs than in non-Hispanic Whites (27% vs. 22%). The National Health Interview Survey found a similar disparity of 35% vs 26% in ANAIs vs. Whites. As in non-Hispanic Whites, 61% of ANAIs with hypertension were taking anti-hypertensive medication. In a previous study, an investigator on the present proposal examined the health records of 524 ANAI elders, finding that 23% had undiagnosed hypertension, and 38% had diagnosed hypertension. Of those with diagnoses, 81% were taking medication, 37% had well-controlled blood pressure (BP), and lifestyle counseling was rare.

Ongoing management of high BP often requires healthcare providers to initiate or intensify therapy in response to uncontrolled high BP. A recent review concluded that the patient/provider relationship, patient/provider communication, and patient-centered decision making were essential to appropriate decisions on medication change. Another study using electronic health record (EHR) data on military veterans found that ~60% of patients with hypertension had poorly controlled systolic BP, yet less than half of clinicians made medication changes after a computer-generated notification.

Improving BP control requires the involvement not only of individuals but of healthcare systems and social environments. Communications must extend care to patients "where patients are" outside the clinic; facilitate BP self-management; and minimize barriers to care AN/AIs face in healthcare access. Across Alaska, 60% of residents are medically underserved, and in 75% of Alaskan communities, regardless of residents' race, comprehensive healthcare services are accessible only by air or water. Even in urban areas, health disparities among AN/AIs persist, and access to care is affected by factors such as lack of transportation.

CVD morbidity, mortality, and organ damage are more accurately predicted by home blood pressure monitoring (HBPM) than by in-office measurements. HBPM avoids over-treating sporadic high BP readings and "white coat" hypertension while facilitating control of both resistant and "masked" hypertension (high at home and normal in the clinic), which are associated with stroke. Compared to usual care or HBPM alone, HBPM combined with self-titration of medications or with physician, pharmacist, or nurse management leads to better use of medications and BP control. Research shows the value of using HBPM values to trigger modifications in anti-hypertensive regimens, and the addition of provider feedback, patient and provider education, and decision-making support to encourage treatment adjustments improves control even more. HBPM can support patient decision making, provide data to providers, facilitate patient/provider communication, and engage, educate, and empower patients. HBPM devices are widely accepted by patients, who prefer them to clinic-based measurements. HBPM interventions appear to be most effective in patients with less well-controlled BP at baseline. Therefore, tailored HBPM interventions have been developed for minorities, who may receive more benefit from HBPM than Whites.

Significance:

BP-ICAN is innovative in many ways. First, it will be the only rigorous, population-based study about BP control for prevention of CVD and stroke in ANs, and one of very few multilevel interventions in any minority population. Second, the Southcentral Foundation (SCF) service area includes rural, suburban, and urban locations. Third, the intervention design addresses therapeutic inertia, a well-recognized barrier to hypertension control that is often neglected in clinical trials, so the approach to improve self-efficacy and ownership should lead to more timely communication with providers and titration of medications.

The investigators will conduct a group-randomized trial for improving BP control among ANAI adults with diagnosed hypertension. Study group assignment will occur by randomizing all SCF primary care panels to the BP-ICAN or usual care control arms; adults with uncontrolled hypertension will be nested within groups defined by panel, which corresponds to one provider. For each panel, investigators will recruit up to 10 ANAI adults (expecting average of 8-9 per provider, for a total n = 324) who have had systolic BP ≥ 130 mmHg measured at one or more clinic visits in the past 18 months OR who have previously diagnosed hypertension and systolic BP ≥ 130 mmHg measured at the study screening or home screening visit. The study period for all participants will last 12 months.

Participants who are randomized to the BP-ICAN arm will receive education about BP control, CVD and stroke and the importance of hypertension management for prevention, other lifestyle changes that can prevent or reduce morbidity from hypertension, and educational materials about the importance of timely response to uncontrolled hypertension. BP-ICAN arm participants will also receive HBPM equipment (Omron device) and training in its use, interpretation of results, and assistance with communicating high BP values to healthcare providers. Lastly, participants will receive culturally tailored text messages to reinforce the educational material and motivate adherence to HBPM and provider communication strategies. Participants whose providers have been randomized to the control condition will continue to receive care as usual.

Patient-initiated communication about uncontrolled BP will serve as one component of the provider-level intervention. Participants will be trained to sync HBPM and smart phone to automatically upload BP measurements into a data repository using Omron's free wellness application. This will update the participant's data on Omron's Wellness Application website. Investigators plan to use a cloud-based technology platform to serve as a data repository and are working with tribal leadership, institutional privacy officers, compliance officers, and providers on how data will displayed and stored within the health care system. The goal is to make aggregate BP measure data available to providers in either a personal health record (PHR) and/or health information exchange (HIE) that allows for transmission of select measures into the electronic health and or population health record. Note that this protocol was developed based on extensive collaboration with SCF providers.

At the individual level, the primary outcome is within-person change in systolic BP. Secondary outcomes are diastolic BP, anti-hypertensive medication use and adherence, physical activity, weight, and tobacco use. Individual-level outcomes will be measured at baseline, 3 months, 6 months, and 1 year post-baseline. At the provider level, the primary outcome is change in prescribing behavior for medication and other relevant lifestyle changes. At the systems level, the primary outcome is change in systolic BP for all adults with hypertension whose providers are randomized to the BP-ICAN arm vs. the care as usual arm, regardless of whether the adults were directly enrolled into the study.

Study Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Anchorage Native Primary Care Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Denise A Dillard, PhD
      • Wasilla, Alaska, United States, 99645
        • Recruiting
        • Benteh Nuutah Valley Native Primary Care Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Denise A Dillard, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least one visit to SCF providers or Community Health Aides within the previous year
  2. Alaska Native or American Indian
  3. At least 18 years old

  4. Meet one of the following two conditions:

    I. Hypertension diagnosis and 1 SBP >= 140 mmHg in past 24 months in EHR, AND

    1. SBP >= 140 mmHg at research visit or from the mean of BP measures during the home screening period, OR
    2. SBP 130-139 mmHg at research visit or from the mean of BP measures during the home screening period plus at least one comorbid condition as stated in AHA guidelines (cardiovascular disease, heart failure, stroke, atrial fibrillation, chronic kidney disease, kidney transplant, or diabetes) II. No hypertension diagnosis but 1 SBP >= 140 mmHg in past 18 months in EHR, AND
    1. SBP >=140mmHg at research visit or from the mean of BP measures during the home screening period, OR
    2. SBP 130-139 mmHg at research visit or from the mean of BP measures during the home screening period plus at least one comorbid condition as stated in AHA guidelines (cardiovascular disease, heart failure, stroke, atrial fibrillation, chronic kidney disease, kidney transplant, or diabetes)
  5. Ability to provide informed consent
  6. Willingness and ability to use a HBPM
  7. Willingness to complete the necessary data collection procedures, including transmission of BP measurements and permission for study staff to access EHR and/or PHR data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BP-ICAN
Participants in the BP-ICAN arm will receive a home blood pressure monitor to be used twice daily for 12 months. Participants' home blood pressure measurements will be shared with their provider and participants will receive a series of text messages including topics on the importance of managing hypertension, reminders to measure blood pressure with their device, and motivational messages on diet and exercise.
Device: BP-ICAN

One of two home blood pressure monitor devices will be used.

  1. Omron 7 Series Wrist cuff
  2. Omron 10 Series Upper Arm cuff
No Intervention: Control
Participants in the control arm will receive care as usual for the treatment of hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual-level: within-person change in systolic blood pressure
Time Frame: 12 months
Examine change in systolic blood pressure (mmHg) between participants in the intervention group compared to the control group.
12 months
Provider-level: frequency of antihypertensive medication adjustments
Time Frame: 3 months, 6 months, and 12 months
Examine number of medication adjustments (new prescription or change in dose of antihypertensive medications) between participants in the intervention group compared to the control group.
3 months, 6 months, and 12 months
System-level: change in systolic blood pressure for all patients with hypertension
Time Frame: 12 months
Examine change in systolic blood pressure (mmHg) between all patients whose providers are in the intervention group (receiving automated alerts about high blood pressure and pharmacist support), compared to patients whose providers are in the control group (do not receive alerts and pharmacist support).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southcentral Foundation

Collaborators

Washington State University

Investigators

  • Principal Investigator: Denise A Dillard, PhD, Southcentral Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP-ICAN-1U54MD011240-01
  • 2017-08-038 (Other Identifier: Alaska Area Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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