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A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement

Not Applicable
Completed
Conditions
Hypertension
Community-based Participatory Research
Self-management
Technology
Interventions
Behavioral: Enhanced Usual Care (EUC)
Behavioral: Coachman
Registration Number
NCT03724487
Lead Sponsor
Case Western Reserve University
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Enhanced Usual CareEnhanced Usual Care (EUC)The second study condition, Enhanced Usual Care (EUC) will be exposed to routine and standard hypertension education materials and one session on self-monitoring blood pressure.
CoachmanCoachmanThe first study condition, A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN) will be exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.
Primary Outcome Measures
NameTimeMethod
Change in Systolic and Diastolic Blood Pressurebaseline 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]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 Outcome Measures
NameTimeMethod
Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks12 weeks

Achieved Blood Pressure target is defined as the rate of participants that have a blood pressure of at the end of 12 weeks, \< 130 mm Hg for systolic blood pressure and \<80 mmHg diastolic blood pressure, in the intervention group. Percentage of individuals that achieved blood pressure target can range from 0 -100%

Trial Locations

Locations (1)

Case Western Reserve University

🇺🇸

Cleveland, Ohio, United States

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