A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Systolic and Diastolic Blood Pressure
研究概览
简要总结
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.
详细描述
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:
- 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.
- Evaluate the feasibility and acceptability of COACHMAN to improve BP control.
- Compare the difference in BP control between Technology-based intervention (TBI) and Enhanced usual care (EUC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •history of cognitive impairment
- •currently using a medication management app
研究组 & 干预措施
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.
干预措施: Coachman (Behavioral)
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.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Change in Systolic and Diastolic Blood Pressure
时间窗: baseline and 12 weeks
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.
Change in PROMIS Global Health-10 [Health-related Quality of Life]
时间窗: Baseline and 12-weeks
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).
次要结局
- Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks(12 weeks)
研究者
Carolyn Still
Assistant Professor, Frances Payne Bolton School of Nursing
Case Western Reserve University