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

NCT ID: NCT03724487

Last Updated: 2022-08-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-05-01

Brief Summary

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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

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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).

Conditions

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Hypertension Self-management Technology Community-based Participatory Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Coachman

The 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.

Group Type EXPERIMENTAL

Coachman

Intervention Type 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

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.

Group Type EXPERIMENTAL

Enhanced Usual Care (EUC)

Intervention Type 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.

Interventions

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Coachman

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.

Intervention Type BEHAVIORAL

Enhanced Usual Care (EUC)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Still

Assistant Professor, Frances Payne Bolton School of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn H Still, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, School of Nursing

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Still CH, Margevicius S, Harwell C, Huang MC, Martin L, Dang PB, Wright Jnr JT. A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study. Patient Prefer Adherence. 2020 Nov 23;14:2301-2313. doi: 10.2147/PPA.S283086. eCollection 2020.

Reference Type RESULT
PMID: 33262580 (View on PubMed)

Still CH, Dang PB, Malaker D, Peavy TD. The Design and Rationale of a Pilot Study: A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN). J Natl Black Nurses Assoc. 2020 Jul;31(1):52-59.

Reference Type RESULT
PMID: 32853497 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5U54MD002265-12

Identifier Type: NIH

Identifier Source: org_study_id

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