Achieving Blood Pressure Control Together Study

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Community Health Worker (CHW) Intervention; Behavioral: Communication Skills Training; Behavioral: Problem Solving Skills Training

• Registration Number: NCT01902719
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-18
• Study Start: 2013-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Health Worker (CHW) Intervention	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).
CHW and Problem Solving Skills Training	Community Health Worker (CHW) Intervention	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.
CHW Intervention and Communication Skills Training	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.
CHW Intervention and Communication Skills Training	Community Health Worker (CHW) Intervention	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.
CHW and Problem Solving Skills Training	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.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Control	12 months	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.

Trial Locations

Locations (1)

Johns Hopkins East Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States