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Clinical Trials/NCT03724487
NCT03724487
Completed
Not Applicable

A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN)

Case Western Reserve University1 site in 1 country60 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Case Western Reserve University
Enrollment
60
Locations
1
Primary Endpoint
Change in Systolic and Diastolic Blood Pressure
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The prevalence of hypertension among U.S. adults increased from 32% to 46% and African Americans are disproportionately impacted. Self-managing hypertension presents challenges such as dealing with complex treatment regimen, including critical components of recommended hypertension treatment such as self-blood pressure monitoring, and lifestyle modifications involving diet, exercise, and tobacco cessation. African Americans with hypertension have lower adherence to self-management behavior due to multifactorial reasons. Substantial evidence has demonstrated the important role of community support in improving patients' self-management of a variety of chronic illnesses, though integrating technology in such programs are rarely offered.

The purpose of this study is to investigate the effectiveness of a community outreach program using a technology-based intervention (TBI) to support self-managing hypertension (called COACHMAN) to improve BP control.

Detailed Description

COACHMAN targets barriers to hypertension knowledge, medication adherence, problem solving skills, patient-provider communication, and social support in an effort to improve blood pressure control. The investigators will conduct a two-arm randomized control trial (RCT) using a community participatory research approach and mixed methods to evaluate the efficacy of TBI intervention with community support (Coachman) compared to enhance usual care (ECU) among 60 African Americans with uncontrolled hypertension. The investigators aim to: 1. Identify key content, design, and resources from a community of stakeholders, including determining facilitators and barriers of hypertension self-management among African Americans that will inform the development of COACHMAN using a mixed methods approach methods. 2. Evaluate the feasibility and acceptability of COACHMAN to improve BP control. 3. Compare the difference in BP control between Technology-based intervention (TBI) and Enhanced usual care (EUC).

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
May 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolyn Still

Assistant Professor, Frances Payne Bolton School of Nursing

Case Western Reserve University

Eligibility Criteria

Inclusion Criteria

  • self-identifying as African American
  • age 30 years or older
  • diagnosed with hypertension, with a blood pressure \>140/80 mmHg
  • prescribed at least one antihypertensive medication
  • able to read and understand English
  • own a smartphone

Exclusion Criteria

  • history of cognitive impairment
  • currently using a medication management app

Outcomes

Primary Outcomes

Change in Systolic and Diastolic Blood Pressure

Time Frame: baseline and 12 weeks

The primary outcome was a change (reduction) in both the systolic and diastolic blood pressure from baseline to 12 weeks, in which the 12 weeks mean systolic minus the baseline systolic were calculated. The same for 12 week diastolic BP minus the baseline diastolic BP were calculated for a mean change score. The change score (number) can range from no change (0) to a 10 point reduction in blood pressure.

Change in PROMIS Global Health-10 [Health-related Quality of Life]

Time Frame: Baseline and 12-weeks

Change in PROMIS Global Health-10 score (two subscales- Mental and Physical Health) from baseline to 12 weeks. Raw scores range from 4-20, higher scores represent better health. The change score is calculated as a mean difference between the two scores: at baseline and at 12 weeks. Scores are reported as a change value number, on a continuous number scale, that can be negative or positive (0 to 1, higher number better health).

Secondary Outcomes

  • Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks(12 weeks)

Study Sites (1)

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