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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872856
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Washington State University
Information provided by (Responsible Party):
Denise Anne Dillard, Southcentral Foundation

Brief Summary:

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, and 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. 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 500 participants.

Intervention participants will receive a home blood pressure monitor (HBPM), upload their 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 their blood pressure measured using 3 methods (aneroid sphygmomanometer, automated Omron upper arm cuff device, and automated Omron wrist cuff device), complete surveys, and have their height, weight, and arm circumference measured. 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.


Condition or disease Intervention/treatment Phase
Hypertension Device: BP-ICAN Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group randomized comparison trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Blood Pressure Monitoring Intervention for Self-Management of High Blood Pressure Among Alaska Native People
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.

  2. 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. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Hypertension diagnosis based on ICD-9 and/or ICD-10 codes
  5. Systolic BP ≥ 130 mmHg recorded at 1 or more clinic visits in the past 18 months, OR systolic BP ≥ 130 mmHg at the study screening visit
  6. Ability to provide informed consent
  7. Willingness and ability to use a HBPM
  8. 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.

Exclusion Criteria:

1. Currently pregnant


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872856


Contacts
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Contact: Denise A Dillard, PhD 9077298518 dadillard@southcentralfoundation.com
Contact: Michael R Ryan-Todd, MBA 9077296322 mryantodd@southcentralfoundation.com

Locations
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United States, Alaska
Anchorage Native Primary Care Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Denise A Dillard, PhD    907-729-8518    dadillard@scf.cc   
Contact: Steve Tierney, MD    907-729-3340    stierney@scf.cc   
Principal Investigator: Denise A Dillard, PhD         
Benteh Nuutah Valley Native Primary Care Center Recruiting
Wasilla, Alaska, United States, 99645
Contact: Denise A Dillard, PhD    907-729-8518    dadillard@scf.cc   
Contact: Steve Tierney, MD    907-729-3340    stierney@scf.cc   
Principal Investigator: Denise A Dillard, PhD         
Sponsors and Collaborators
Southcentral Foundation
Washington State University
Investigators
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Principal Investigator: Denise A Dillard, PhD Southcentral Foundation

Publications:

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Responsible Party: Denise Anne Dillard, Director of Research, Southcentral Foundation
ClinicalTrials.gov Identifier: NCT03872856    
Other Study ID Numbers: BP-ICAN-1U54MD011240-01
2017-08-038 ( Other Identifier: Alaska Area Institutional Review Board )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Denise Anne Dillard, Southcentral Foundation:
High Blood Pressure
Alaska Native and American Indian
Home Blood Pressure Monitoring
Self-efficacy
Primary Care
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases