Trials / Completed
CompletedNCT03724487
A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement
A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Case Western Reserve University · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2019-11-30
- Completion
- 2020-05-01
- First posted
- 2018-10-30
- Last updated
- 2022-08-16
- Results posted
- 2022-06-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03724487. Inclusion in this directory is not an endorsement.