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

• ClinicalTrials.gov Identifier: NCT03724487
• Recruitment Status: Completed
• First Posted: October 30, 2018
• Last Update Posted: September 16, 2020
• Sponsor: Case Western Reserve University
• Collaborator: University Hospitals Cleveland Medical Center
• Information provided by (Responsible Party): Carolyn Still, Case Western Reserve University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Self-management; Technology; Community-based Participatory Research	Behavioral: Coachman; Behavioral: Enhanced Usual Care (EUC)	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN)
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: November 30, 2019
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change in systolic and diastolic blood pressure [ Time Frame: Baseline to 8 weeks and 12 weeks ]
   Measure of participants' in clinic blood pressure (average of three blood pressure readings)
2. PROMIS Global Health-10 [health-related quality of life] [ Time Frame: Baseline to 8 weeks and 12 weeks ]
   Change in total summed score on PROMIS Global Health-10. Higher scores indicate greater health-related quality of life. Range is 4-20.

Secondary Outcome Measures :

1. Achieved systolic and diastolic blood pressure [blood pressure <130/80 mmHg] [ Time Frame: From Baseline to 12 weeks ]
   Achieved blood pressure of 130/80 mmHg in >65% of the study sample. Measure of participants' in clinic blood pressure (average of three blood pressure readings)
2. Hill-Bone Compliance Scale [high blood pressure therapy scale, medication compliance, appointment keeping, and salt intake] [ Time Frame: Baseline to 8 weeks and 12 weeks ]
   Change in total summed score on Hill-Bone Compliance Scale. Higher scores indicate greater levels of noncompliance or adherence to hypertension treatment. Range 14-56.
3. Patient Activation Measure - PAM [patient knowledge, skills, and confidence to engage in self-management of chronic illness] [ Time Frame: Baseline to 8 weeks and 12 weeks ]
   Change in transformed score on PAM. Higher scores indicate greater levels of patient activation. Range from 38.6-53 (theoretical range 0-100).

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Case Western Reserve University

Cleveland, Ohio, United States, 44143

Sponsors and Collaborators

Case Western Reserve University

University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Carolyn H Still, PhD; Case Western Reserve University, School of Nursing

More Information

• Responsible Party: Carolyn Still, Assistant Professor, Frances Payne Bolton School of Nursing, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT03724487
• Other Study ID Numbers: 5U54MD002265-12 ( U.S. NIH Grant/Contract )
• First Posted: October 30, 2018
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases