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

NCT03872856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-08-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Washington State University

    collaborator OTHER

  • Southcentral Foundation

    lead OTHER

Principal Investigators

  • Denise A Dillard, PhD · Southcentral Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2022-09-30
Completion
2023-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872856 on ClinicalTrials.gov