A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement
NCT ID: NCT03724487
Last Updated: 2022-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-03-01
2020-05-01
Brief Summary
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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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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* currently using a medication management app
30 Years
ALL
Yes
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Case Western Reserve University
OTHER
Responsible Party
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Carolyn Still
Assistant Professor, Frances Payne Bolton School of Nursing
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
Countries
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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