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临床试验/NCT03470701
NCT03470701已完成不适用

Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population

Geisinger Clinic1 个研究点 分布在 1 个国家目标入组 999 人开始时间: 2018年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
999
试验地点
1
主要终点
Completion of albuminuria screening

研究概览

简要总结

This study will test the effectiveness of mailed, smartphone urinalysis kits to improve albuminuria screening compliance and detection of albuminuria.

详细描述

This proposal will examine the effect of mailed, smartphone urinalysis kits to improve albuminuria screening compliance and detection of albuminuria. The investigators will randomize 1,000 non-diabetic MyGeisinger portal users with hypertension and last clinic blood pressure >= 130/80 mmHg who have not received albuminuria screening to either: 1) control - usual care or 2) intervention - mailed urinalysis smartphone kit. All patients will first receive a reminder letter to have albuminuria screening completed at their clinic in coordination with the Geisinger Care Gap Team. Patients randomized to the intervention arm who do not complete this initial screening test will then be offered a mailed, smartphone urinalysis testing kit. Patients with 1+ or greater detected urine protein will be recommended to have urine albumin/creatinine ratio (ACR) testing to confirm albuminuria. Patients with ACR >= 30 mg/g will be referred to pharmacists for optimal treatment of albuminuria (ACE or ARB, statin, BP goal <130/90 mmHg).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •18 and older
  • •Hypertension
  • •Last outpatient BP ≥ 130/80 mmHg
  • •Active MyGeisinger users with a listed mobile phone number
  • •Has a Geisinger PCP and followed by the Care Gaps team
  • •No prior urine albuminuria test (urine dipstick, albumin/creatinine ratio, protein/creatinine ratio)

排除标准

  • •History of diabetes
  • •Receiving dialysis
  • •History of kidney transplant
  • •eGFR < 15 ml/min/1.73m2
  • •Principal investigator or PCP discretion (i.e. concerns about safety, compliance)

研究组 & 干预措施

Control - usual care

No Intervention

This arm will receive usual care.

Mailed Urinalysis Smartphone Kit

Experimental

This arm will receive a mailed urinalysis smartphone kit if they do not complete albuminuria screening after the initial reminder to do so.

干预措施: Mailed Urinalysis Smartphone Kit (Other)

结局指标

主要结局

Completion of albuminuria screening

时间窗: Baseline to 3 months of enrollment date

Includes completion of mailed smartphone urinalysis and clinical labs (urinalysis, albumin/creatinine ratio, or protein/creatinine ratio)

Total number of detected albuminuria cases

时间窗: Baseline to 3 months of enrollment date

confirmed by urine albumin/creatinine ratio \>= 30 mg/g

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Chang

Assistant Professor

Geisinger Clinic

研究点 (1)

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