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

NCT03872856 | Completed DMC FDA Device

• 2 other identifiers: BP-ICAN-1U54MD011240-012017-08-038
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief Summary

"Blood Pressure: Improving Control among Alaska Native People" (BP-ICAN) that targets blood pressure control among Alaska Native and American Indian (AN/AI) people diagnosed with hypertension. Participants will include adults with a diagnosis of hypertension who have not achieved blood pressure control. 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. Data will be collected 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.

Conditions

Hypertension

Keywords

High Blood Pressure; Alaska Native and American Indian; Home Blood Pressure Monitoring; Self-efficacy; Primary Care

Outcome Measures

Primary Outcomes (3)

• Individual-level: within-person change in systolic blood pressure

  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

  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

  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

Study Arms (2)

BP-ICAN

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Participants in the control arm will receive care as usual for the treatment of hypertension

Interventions

BP-ICAN DEVICE

One of two home blood pressure monitor devices will be used. 1. Omron 7 Series Wrist cuff 2. Omron 10 Series Upper Arm cuff

BP-ICAN

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one visit to SCF providers or Community Health Aides within the previous year
• Alaska Native or American Indian
• At least 18 years old
• Meet one of the following two conditions:
• I. Hypertension diagnosis and 1 systolic blood pressure (SBP) \>= 140 mmHg in past 24 months in EHR, AND
• SBP \>= 140 mmHg at research visit or from the mean of BP measures during the home screening period, OR
• 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 American Heart Association 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
• <!-- -->
• SBP \>=140mmHg at research visit or from the mean of BP measures during the home screening period, OR
• 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)
• Ability to provide informed consent
• Willingness and ability to use a HBPM
• 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.

Sponsors & Collaborators

• Southcentral Foundation: lead
• Washington State University: collaborator

Study Sites (2)

Anchorage Native Primary Care Center

Anchorage, Alaska, 99508, United States

Location

Benteh Nuutah Valley Native Primary Care Center

Wasilla, Alaska, 99645, United States

Location

Related Publications (39)

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MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Denise A Dillard, PhD

  Southcentral Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Group randomized comparison trial

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 13, 2019
• Study Start: February 19, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)