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Southeastern Collaboration to Improve Blood Pressure Control

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ClinicalTrials.gov Identifier: NCT02866669
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Andrea Cherrington, MD, University of Alabama at Birmingham

Brief Summary:

The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".

The Agency for Healthcare Research and Quality (AHRQ) Disparities Report identifies individuals with rural residence, minority ethnicity, and low SES as being at high risk for poor health outcomes. The "Black Belt" region stretches from eastern Texas in an arc to Maryland and includes residents with all 3 of these characteristics - the proverbial triple threat. This traditionally agricultural region is characterized by steep poverty, low educational attainment, scarce resources, and mostly African American residents. The Black Belt is in the heart of the Stroke Belt, a geographic area long recognized to have the highest cardiovascular disease (CVD) mortality in the US. The AHRQ Disparities Report also cites that the Southeast has lower quality of care than the rest of the US, thus effective strategies to optimize CVD prevention in general and hypertension (HTN) control specifically are urgently needed here.

In year 1 (AIM 1) we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test these interventions.


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Practice Facilitation Behavioral: Peer Coach Behavioral: Enhanced usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Collaboration to Improve Blood Pressure in the US Black Belt-addressing the Triple Threat
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enhanced usual care
Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.
Behavioral: Enhanced usual care
Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.

Experimental: Practice facilitation
Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
Behavioral: Practice Facilitation
ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction

Behavioral: Enhanced usual care
Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.

Experimental: Peer coach
Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.
Behavioral: Peer Coach
Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.
Other Name: Taking Control of Your Health

Behavioral: Enhanced usual care
Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.

Experimental: Peer coach and Practice facilitation
Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months.
Behavioral: Practice Facilitation
ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction

Behavioral: Peer Coach
Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.
Other Name: Taking Control of Your Health

Behavioral: Enhanced usual care
Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.




Primary Outcome Measures :
  1. change in blood pressure control control at 12 months [ Time Frame: baseline and 12 months ]
    change in BP control between baseline and follow-up between practices in any of the intervention arms and the enhanced usual care arm


Secondary Outcome Measures :
  1. change in systolic blood pressure at 12 months [ Time Frame: baseline and 12 months ]
    change in systolic blood pressure at 12 months

  2. change in satisfaction using the patient assessment of chronic illness care" [ Time Frame: Baseline, 12 months ]
    change in satisfaction measured using self report scale "patient assessment of chronic illness care"

  3. change in satisfaction using the Chronic Illness Resources Survey [ Time Frame: Baseline, 12 months ]
    change in satisfaction measured using self report scale "Chronic Illness Resources Survey"

  4. change in health related quality of life [ Time Frame: Baseline, 12 months ]
    change in health related quality of life measured using self report scale Short form-12

  5. change in depressive symptoms [ Time Frame: Baseline, 12 months ]
    change in depressive symptoms measured using self report scale 8 item Patient Health Questionnaire

  6. change in perceived stress [ Time Frame: Baseline, 12 months ]
    change in perceived stress measured using self report scale 4 item Perceived stress scale

  7. change in social support [ Time Frame: Baseline, 12 months ]
    change in social support measured using self report scale "Patient-reported outcomes measurement information system (PROMIS) Social functioning scale"

  8. change in hypertension knowledge [ Time Frame: Baseline, 12 months ]
    change in hypertension knowledge measured using self report scale "Hypertension Knowledge and attitudes"

  9. change in patient activation measured [ Time Frame: Baseline, 12 months ]
    change in patient activation measured using self report scale 4 item patient activation measure

  10. change in medication adherence [ Time Frame: Baseline, 12 months ]
    change in medication adherence measured using self report scale "4-item medication adherence scale"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American adults aged 19-85 years
  • Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
  • Black Belt resident
  • English speaking
  • Willing to work with a peer coach
  • Willing to sign informed consent

Exclusion Criteria:

  • Plans to move out of the area within the next two years
  • Advanced illness with limited life expectancy
  • Pregnant or plans to get pregnant in the next year
  • Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
  • Unwillingness to work with a peer coach or to sign informed consent

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): NCT02866669


Contacts
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Contact: Andrea Cherrington, MD 2059962885 Cherrington@uab.edu

Locations
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United States, Alabama
University of Alabama At Birmingham Recruiting
Birmingham, Alabama, United States, 35205
Contact: Andrea Cherrington    205-996-2885    cherrington@uab.edu   
Contact: Kim Jenkins    (205) 934-7157    jenkinsk@uab.edu   
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 37599
Contact: Anthony Viera       anthony_viera@med.unc.edu   
Contact: Madeline Mitchell    919.966.6074    Madeline_Mitchell@unc.edu3   
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Doyle Cummings    252-744-2607    CUMMINGSD@ecu.edu   
Contact: Alyssa Adams    252.744.2609    adamsal14@ecu.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Andrea Cherrington, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02866669     History of Changes
Other Study ID Numbers: X160722009
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No