Pilot Study of Home Blood Pressure Control Program (eBP Control)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Percent of patients at BP goal
研究概览
简要总结
This intervention study will evaluate the feasibility,acceptability and effectiveness of an e-health enabled model of care by randomly assigning a trained patient navigator and/or a blood pressure (BP) self-management web portal to patients with uncontrolled hypertension after a run in period with a home BP monitor (HBPM) and comparing the results on blood pressure control. We anticipate that patients receiving the combination of a patient navigator(PN)with a self-management web portal and home BP monitor will have better BP control than when the only received a home BP monitor.
详细描述
The study will demonstrate and evaluate the feasibility and acceptability of an e-health enabled model of care for improved hypertension and elevated blood pressure control using a home blood pressure monitor (HBPM), a blood pressure (BP) self-management web portal, and a trained patient navigator. During the first or the control period, all of the participants will have access to the only the HBPM. The control period will be compared to the final or the intervention period when the participants will gain access to a trained patient navigator and the web portal. This comparison will assist in estimating the effect sizes of the HBPM plus PN plus self-management web portal to HBPM alone for each of the outcomes: patient activation, self-management activities, medication adherence, reduced clinical inertia, and improved BP control. The second of the randomization periods will allocate a patient navigator to half of the participants, while the other half will gain access to only the web portal. We will compare the effectiveness of the PN plus webportal plus HBPM to webportal plus HBPM during this second period. An evaluation of the intervention process will delineate the barriers and facilitators by the providers, participants, and patient navigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed w/ hypertension or elevated blood pressure, uncontrolled blood pressure at the baseline research visit according to the following risk levels:
- •Average risk,
- •SBP >140 mmHg or DBP > 90 mmHg;
- •Vascular disease (cerebrovascular disease, coronary heart disease, diabetes mellitus, peripheral vascular disease, renal insufficiency)
- •SBP >130 mmHg or DBP >80 mmHg;
- •Left ventricular dysfunction,
- •SBP 120 mmHg or DBP >80 mmHg;
- •can read and understand English; must have access to internet
排除标准
- •Unable to comply with protocol;
- •pregnancy;
- •secondary hypertension (e.g. renovascular);
- •participation in other hypertension clinical trials;
- •hospitalized in the past six months for diabetes, renal failure, or heart failure;
- •severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min);
- •patient already routinely using a home blood pressure monitoring device or patient not able to use HBPM device due to disability;
- •arm circumference larger than 17 inches determined during telephone screener,
- •arm circumference smaller than 9 inches measured at baseline research visit.
研究组 & 干预措施
HBPM only
HBPM+website+patient navigator
干预措施: HBPM+website+patient navigator (Behavioral)
结局指标
主要结局
Percent of patients at BP goal
时间窗: Nine months
Percentage of patients at systolic and/or diastolic blood pressure at goal at the fourth research visit (end of the study)
次要结局
- Costs(Nine months)
- Health status(Nine Months)
- Use of intervention tools(Nine months)
研究者
Charles B. Eaton
Director of Center for Primary Care and Prevention
Memorial Hospital of Rhode Island