NCT02996565已完成不适用
Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,072
- 试验地点
- 2
- 主要终点
- Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)
研究概览
简要总结
This pragmatic trial will compare two team-based care models for managing hypertension, Best Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care system in Minnesota. Clinics in the study are randomized to offer one of the two treatment models to participants with uncontrolled hypertension.
The investigators aim to determine a) whether one model is more effective than the other for lowering patient's blood pressure and b) which model patients prefer.
详细描述
The objectives of the study are:
Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and other outcomes important to patients: best-practice clinic-based care and home-based telehealth care.
- Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in systolic blood pressure over 12 months of follow-up.
- Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will report: a) fewer treatment side effects; b) better ratings of patient experience of hypertension care; and c) higher self-monitoring rates and confidence in self-care.
Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the telehealth care and clinic-based care interventions using a mixed-methods approach supported by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hypertension diagnosis code in medical record, twice in last 24 months
- •Attends study clinic for primary care visit within study period with uncontrolled blood pressure
- •Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at current visit
- •Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at most recent previous visit
排除标准
- •Pregnancy
- •End Stage Kidney Disease
- •Patients in hospice care and patients who permanently reside in a nursing home
结局指标
主要结局
Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)
时间窗: Trajectory over 12 months
Change in systolic BP, collected from medical records
次要结局
- Change in Diastolic BP Between Baseline and 12 Months (mm Hg)(Trajectory over 12 months)
- Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up(Baseline to 6 months)
- Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.(Baseline to 6 months)
- Number of Participants Who Are Current Smokers at Twelve Months(Baseline to 12 months)
- Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months(Baseline to 6 months)
- Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months(Baseline to 6 months)
- Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months(Baseline to 6 months)
- Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months(Baseline to 6 months)
- Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months(Baseline to 6 months)
- Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months(Baseline to 6 months)
- Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months(Baseline to 6 months)
- Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months(Baseline to 6 months)
- Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months(Baseline to 6 months)
- Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months(Baseline to 6 months)
- Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months(Baseline to 6 months)
- Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Reporting Measuring BP as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Reporting Phone Visits as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months(Baseline to 6 months)
- Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team(Baseline to 6 months)
- Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months(Baseline to 6 months)
- Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months(Baseline to 6 months)
- Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months(Baseline to 6 months)
- Number of Participants Reporting High Confidence in Taking BP Medications at Six Months(Baseline to 6 months)
- Number of Participants With Statin Addition at 12 Months(Baseline to 12 months)
研究者
研究点 (2)
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