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临床试验/NCT05789706
NCT05789706已完成不适用

Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans: a Pragmatic, Point-of-care, Implementation Effectiveness Pilot Study

VA Sierra Nevada Health Care System2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月24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
30
试验地点
2
主要终点
Change from pre-intervention baseline in hemoblobin A1c

研究概览

简要总结

The purpose of this study is to determine if a novel smartphone-based medication adherence platform accompanied by directed pharmacist intervention can improve A1c control and medication compliance in non-insulin dependent diabetics.

详细描述

This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm (See Figure 1). Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.

Primary outcomes will be the change from pre-intervention baseline in hemoblobin A1c (HgA1c) between the Dayamed Arthur platform and standard of care.

Secondary outcomes will include change in MAS, the change in RMA from week 1 of intervention arm to week 12, comparison of historical MPR and PDC with patient's RMA at week 1 of intervention arm, and correlation of change in RMA and MAS score during intervention arm. Furthermore, we will measure sustained change in MAS in the patient population who begin study in the intervention arm and are subsequently transitioned to standard of care. We will also collect information patient usability/acceptability and provider satisfaction with the Dayamed Arthur platform.

Exploratory outcomes will include potential reduction in healthcare resource utilization based on avoidance of therapy escalation in patients with improved compliance, as well as psychosocial factors associated with improved adherence

Reduction of HgbA1c by 0.5% from pre-intervention baseline for individuals on the DayaMed intervention compared to standard of care

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
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

  • Assigned primary care provider at VA Sierra Nevada Healthcare System (VASNHCS)
  • Diagnosis of type 2 diabetes
  • Own a smart phone/tablet
  • HgbA1c drawn at or within 30 days of study enrollment.
  • Uncontrolled A1c defined as an A1c >9 in the following order of preference
  • Last 3 A1cs >9% in the last 2 year
  • Last 2 A1cs >9% in the last 2 years
  • Last A1c >9% in the last 2 years
  • 2-year average A1c >9%

排除标准

  • Actively on insulin therapy
  • Unable to install DayaMed application onto their phone/tablet
  • Unable to load medications

结局指标

主要结局

Change from pre-intervention baseline in hemoblobin A1c

时间窗: 3 months

The change from pre-intervention baseline in hemoblobin A1c (HgA1c) to 3 months in the intervention arm compared to change from baseline to 3 months in the standard of care arm

次要结局

  • Change in Medication Adherence Score from baseline(3 months)

研究者

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

Amneet Rai

Associate Chief of Pharmacy - Health Outcomes and Analytics

VA Sierra Nevada Health Care System

研究点 (2)

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