Achieving Blood Pressure Control Together Study (ACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leigh Ebony Boulware, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01902719
First received: July 16, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

African Americans represent a particularly vulnerable subgroup of persons with hypertension, as they are more likely than Whites to have hypertension, equally as likely to be aware of it and to be treated for it, but less likely to achieve blood pressure control while receiving treatment. African Americans are also more likely than Whites to suffer end organ damage as a result of hypertension. Patients' hypertension self-management behaviors (including adherence to prescribed care, self-blood pressure monitoring, lifestyle changes, and shared medical decision-making) represent a cornerstone of hypertension therapy. Evidence suggests some African Americans with hypertension may experience difficulties carrying out positive self-management behaviors, in part due to cultural beliefs and practices, knowledge and perceptions regarding the nature and consequences hypertension, and lack of systems to support ongoing engagement in prescribed care within their communities. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses.

The goal of this study is to rigorously test the effectiveness of hypertension self-management interventions that engage African American patients, their families, and their community-level resources to improve African American patients' blood pressure.

We hypothesize patients' hypertension control rates may be improved when combining community health worker self-management support with other types of hypertension self-management skills training.


Condition Intervention
Hypertension
Behavioral: Community Health Worker (CHW) Intervention
Behavioral: Communication Skills Training
Behavioral: Problem Solving Skills Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family and Community Intervention to Address Hypertension Disparities

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Blood Pressure Control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hypertension control based on JNC-7 guidelines and changes in systolic and diastolic blood pressure. Blood pressure (BP) will be measured by trained and certified observers during regularly scheduled clinical visits at EBMC using an automatic oscillometric monitor (Omron HEM 907-XL). This device programs a five-minute delay before activation and has a 30-second delay between the triplicate measurements. We will use two measures — the average of all three measurements and the average of the last two measurements — obtained at each time point at baseline, 4 months, and 12 months follow-up.


Estimated Enrollment: 336
Study Start Date: September 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Community Health Worker (CHW) Intervention
Participants randomized to this arm will receive the Community Health Worker Intervention that will include training in the use of home blood pressure machine, education on diet and exercise, and one-on-one support to assist with overcoming barriers to hypertension control (e.g., accessing healthcare, social and community services).
Behavioral: Community Health Worker (CHW) Intervention
Receipt of training in use of home blood pressure machine, education about diet, exercise and physical activities to lower blood pressure, and continued support from a trained community health worker.
Experimental: CHW Intervention and Communication Skills Training
Participants randomized to this arm will receive the Community Health Worker Intervention and a communication skills training to partner with their physician providers in a way that encourages their greater involvement and shared decision-making with their physicians about hypertension care.
Behavioral: Community Health Worker (CHW) Intervention
Receipt of training in use of home blood pressure machine, education about diet, exercise and physical activities to lower blood pressure, and continued support from a trained community health worker.
Behavioral: Communication Skills Training
Receipt of "Do My PART" (P-Prepare for Visit, A- Act at visit, R-Review doctor's recommendations, T-Take home recommendations)communication skills training.
Experimental: CHW and Problem Solving Skills Training
Participants randomized to this arm will receive the Community Health Worker Intervention and the Problem Solving Skills Training Intervention, a 9-week peer based self-management intervention to help patients improve their hypertension self-management by learning and employing skills to overcome their self-identified barriers to self-management.
Behavioral: Community Health Worker (CHW) Intervention
Receipt of training in use of home blood pressure machine, education about diet, exercise and physical activities to lower blood pressure, and continued support from a trained community health worker.
Behavioral: Problem Solving Skills Training
Receipt of a 9-week group based self-management intervention designed to help patients identify and solve self-identified barriers to hypertension control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years and above
  • African American/Black
  • English speaking
  • Two Blood Pressure values >=140/>=90 in 6 months prior
  • Seen at East Baltimore Medical Center

Exclusion Criteria:

  • 18 years and less
  • Non African American/Black
  • Not English speaking
  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902719

Locations
United States, Maryland
Johns Hopkins East Baltimore Medical Center
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Leigh E Boulware, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Leigh Ebony Boulware, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01902719     History of Changes
Other Study ID Numbers: NA_00078591, 1P50HL105187
Study First Received: July 16, 2013
Last Updated: June 3, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014