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临床试验/NCT03596242
NCT03596242已完成不适用

Short Message Service System for Patients With Uncontrolled Hypertension

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Number of Participants Screened

研究概览

简要总结

This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital.

详细描述

The pilot will evaluate the feasibility of implementing a Short Message Service (SMS) system and Home Blood Pressure Measurements (HBPM) in the Outpatient Internal Medicine (OPD) clinic at Wake Forest Baptist Hospital. Implementing a new short text messaging service will improve the health delivery system in three ways. 1) Increasing patient engagement: SMS and HBPM require an active commitment by the patients themselves in their medical care and results in a marked improvement in the adherence to medication. High adherence to home blood pressure (BP) measurements has also been reported to improve BP control. 2) Supporting patients outside of the office visits by identifying and resolving barriers to medication adherence earlier on (i.e. if patients are unable to get their prescriptions or are having significant side effects). 3) Adopting clinical guidelines to improve BP control in a vulnerable population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have been diagnosed with hypertension
  • 18 and older
  • stage 2 hypertension or greater systolic blood pressure [(SBP)>140 and diastolic blood pressure (DBP) >90] who are receiving antihypertensive treatment.

排除标准

  • Pregnancy
  • end-stage renal disease (on hemodialysis or peritoneal dialysis)
  • hospice or nursing home care
  • Patients who do not have a phone with Short Message Service (SMS) capabilities will also be excluded.

结局指标

主要结局

Number of Participants Screened

时间窗: during screening period, about 6 months

Number of Subjects Excluded Without SMS Capability

时间窗: baseline

Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.

Proportion of Participants Continuing myHealth

时间窗: up to 12 weeks

the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention

SMS Participation

时间窗: up to 12 weeks

The number of patients who participate in SMS will be recorded

System Usability Scale (SUS)

时间窗: Week 12

Participants will complete the SUS in person on an I-Pad or over the phone. The SUS yields a single score on a scale of 0-100. A SUS score above a 68 would be considered above average (better) usability.

Number of Subjects Enrolled

时间窗: during baseline period, about 4 months

Number of Subjects Who Refuse Participation

时间窗: baseline

number of participants who refuse to participate at the time of recruitment and the reason why

Number of Participants Who Responded to SMS With At Least One Home BP Measurement

时间窗: up to 12 weeks

次要结局

  • Medication Adherence(up to 12 weeks)
  • Medication Adherence Questionnaire(baseline, week 12)
  • Number of Participants Considered No-Shows at Clinic Visits(week 12)
  • Monitoring of DBP(baseline and 12 weeks)
  • Initial and Follow up BP in Office(baseline/day 0 and 12 weeks)
  • Coordinator Time(up to 12 weeks)
  • Monitoring of SBP(baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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