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Evaluating CVD Medication Adherence Program in Low SES (CVDMAT)

2016年8月11日 更新者：Duke University
The investigators propose to evaluate the implementation of an efficacious medication adherence program in a group at high risk for CVD. The program involves patients receiving/responding to e-reminders to take CVD medications via patient-selected technology [mobile/web-based applications, short message service (SMS; text messaging), interactive voice response (IVR), or e-mail] supported by a tailored, monthly, self-management program administered by either research staff or a case manager staff member from the Duke Outpatient Clinic via the telephone. This is a hybrid type II implementation science study.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The investigators propose to evaluate the implementation of a medication adherence program among patients who attend Duke Outpatient Clinic (DOC). It is anticipated that, among the providers' patient panels, at least 100 and up to 300 with CVD risk and poor CVD medication adherence (<0.08 medication possession ratio) will consent to the program.

Using procedures from the investigators previous studies, the investigators will identify potential patients from the EHR, and will identify a pool of potential patients using electronic health records, with the goal of administering the program to at least 100 patients. Patients will be mailed letters, signed by their own provider or medical director of DOC, requesting their participation in the programs. The RA will contact patients via telephone to explain the study, screen for eligibility, and determine what mode of administration individuals prefer to receive the program (SMS, IVR, or email).

The primary outcome will be that the effectiveness/impact of the proposed adherence program will be a 10% improvement in MPR and CVD outcomes (anticipate reducing SBP by 5 mmHg, Hgb a1c by 0.5%, LDL-C by 20 mg/dl).

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • North Carolina
      • Durham、North Carolina、美国、27705
        • Duke University Health System Clinic

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Medicaid recipient (preferred); however the investigators will include those patients with other types of insurance or those who are uninsured
  2. Enrolled in Duke Outpatient Clinic for at least one year
  3. Outpatient diagnostic code for hypertension and/or hypercholesterolemia and/or diabetes
  4. Poorly controlled BP levels (>140/90) and/or LDL-C (>130mg/dl) and/or HbA1c of >8 within last 6 months

Exclusion Criteria:

  1. No access to cell phone
  2. Not proficient in English
  3. Nursing home/long-term care facility resident or receiving home health care
  4. Impaired hearing/ speech/ vision
  5. Participating in another trial (pharmaceutical or behavioral)
  6. Planning to leave the area in the next 12 months
  7. Pregnancy (or planning)
  8. Diagnosis of life-threatening disease with death probable within 1 year
  9. Active Diagnosis of psychosis or dementia (has been hospitalized in the last 30 days)
  10. Diagnosis of ESRD

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：m-health
Patients will receive text message, emails, and monthly phone calls
行为的：m-health
Patients will receive e-reminders via text message and email. A message library that allows us to disseminate constant and reliable information has been created. Messages will contain not only medication reminders, but information about issues related to self-management and medication adherence for CVD risk including messages on side-effects, risks/benefits of medication treatment, and barriers to medication adherence. In addition to these messages, patients will also receive tailored information via telephone by trained research staff.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adherence to the program's intervention
大体时间：6 months
It is measured as the proportion of technology or interventionist contacts responded to by a patient out of those received over the course of the intervention period. This will be summarized descriptively by type of contact (technology vs. interventionist call) and subdivided by technology (SMS, email).
6 months

次要结果测量

结果测量
措施说明
大体时间
Clinical effectiveness/impact of the program to pill refill adherence
大体时间：6 months
This will be measured by pulling pill refill records of those patients who are enrolled. The investigators anticipate an improvement of 10% on pill refill adherence.
6 months
Clinical effectiveness/impact on BP
大体时间：6 months
This will be measured by assessing systolic BP values. The investigators anticipate reducing SBP by 5 mmHg.
6 months
Clinical effectiveness/impact on A1C
大体时间：6 months
This will be measured by assessing A1C values. The investigators anticipate reducing Hgb A1c by 0.5%.
6 months
Clinical effectiveness/impact on cholesterol
大体时间：6 months
This will be measured by assessing LDL-C levels in patients. The goal is to reduce LDL-C levels by 20 mg/dl.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Duke University

合作者

PhRMA Foundation

调查人员

  • 首席研究员：Hayden Bosworth, PhD、Duke University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年1月1日

初级完成 (实际的)

2016年6月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2015年1月16日

首先提交符合 QC 标准的

2015年2月25日

首次发布 (估计)

2015年3月3日

研究记录更新

最后更新发布 (估计)

2016年8月12日

上次提交的符合 QC 标准的更新

2016年8月11日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Pro00054572

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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