Achieving Blood Pressure Control Together Study (ACT)

Family and Community Intervention to Address Hypertension Disparities

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Community Health Worker (CHW) Intervention; Behavioral: Communication Skills Training; Behavioral: Problem Solving Skills Training

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Johns Hopkins East Baltimore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Control	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.	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Leigh E Boulware, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Murphy KA, Greer RC, Roter DL, Crews DC, Ephraim PL, Carson KA, Cooper LA, Albert MC, Boulware LE. Awareness and Discussions About Chronic Kidney Disease Among African-Americans with Chronic Kidney Disease and Hypertension: a Mixed Methods Study. J Gen Intern Med. 2020 Jan;35(1):298-306. doi: 10.1007/s11606-019-05540-3. Epub 2019 Nov 12.
• Boulware LE, Ephraim PL, Hill-Briggs F, Roter DL, Bone LR, Wolff JL, Lewis-Boyer L, Levine DM, Greer RC, Crews DC, Gudzune KA, Albert MC, Ramamurthi HC, Ameling JM, Davenport CA, Lee HJ, Pendergast JF, Wang NY, Carson KA, Sneed V, Gayles DJ, Flynn SJ, Monroe D, Hickman D, Purnell L, Simmons M, Fisher A, DePasquale N, Charleston J, Aboutamar HJ, Cabacungan AN, Cooper LA. Hypertension Self-management in Socially Disadvantaged African Americans: the Achieving Blood Pressure Control Together (ACT) Randomized Comparative Effectiveness Trial. J Gen Intern Med. 2020 Jan;35(1):142-152. doi: 10.1007/s11606-019-05396-7. Epub 2019 Nov 8.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (ESTIMATE): July 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 2, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NA_00078591; 1P50HL105187 (NIH)