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

NCT03724487 | Completed Results DMC

• 1 other identifier: 5U54MD002265-12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Self-management; Technology; Community-based Participatory Research

Outcome Measures

Primary Outcomes (2)

• Change in Systolic and Diastolic Blood Pressure

  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.

  baseline and 12 weeks

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

  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).

  Baseline and 12-weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

Coachman

EXPERIMENTAL

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.

Behavioral: Coachman

Enhanced Usual Care

EXPERIMENTAL

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.

Behavioral: Enhanced Usual Care (EUC)

Interventions

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.

Coachman

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44143, United States

Location

Related Publications (2)

• 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.

  PMID: 33262580 RESULT

• 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.

  PMID: 32853497 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Carolyn Still, Assistant Professr
• Organization: Case Western Reserve University

cwh11@case.edu

216-368-6338

Study Officials

• Carolyn H Still, PhD

  Case Western Reserve University, School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Frances Payne Bolton School of Nursing

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: October 30, 2018
• Study Start: March 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: May 1, 2020
• Last Updated: August 16, 2022
• Results First Posted: June 9, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting in Dec 2026

Locations

US (1)