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NCT Number: NCT03724487

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Community-Based Participatory Research Self-management Technology Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44143, United States

About this study

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:

  • 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.
  • Evaluate the feasibility and acceptability of COACHMAN to improve BP control.
  • Compare the difference in BP control between Technology-based intervention (TBI) and Enhanced usual care (EUC).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coachman

Behavioral

Coachman is comprised of: TBI and nurse counseling. TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure. Participants will be exposed to nurse counseling, by registered nurses from the community, affiliated with a local nurse organization that will serve as community health workers (CHWs). The CHWs will provide informal counseling, social support, as well as follow-up phone sessions on medication adherence and monitoring blood pressure.

enhanced usual care (EUC)

Behavioral

Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure.

Primary outcomes

  1. 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.

  2. 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

  1. Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks

    Time frame: 12 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%

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • University Hospitals Cleveland Medical Center

Registry information

Official study title

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

Acronym: Coachman

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 30, 2018
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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