跳至主要内容
临床试验/NCT01427660
NCT01427660已完成不适用

Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information

University of Michigan1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2011年9月1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
190
试验地点
1
主要终点
Changes in decisional conflict

研究概览

简要总结

Two of AHRQ 's consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.

To achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan's Center for Health Communications Research [CHCR] and Center for Behavioral and Decision Sciences in Medicine [CBDSM]).

The investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.

详细描述

The Specific Aims of this study are:

Aim 1: To use the information in the two diabetes medications consumer CERSGs to build an interactive, computer tailored diabetes medication guide that will enable patients to assess their treatment goals, personal preferences, and side-effect concerns and generate a personally tailored assessment of their current diabetes treatments with, as appropriate, options for improving their diabetes care;

Aim 2: To determine the extent to which this personally tailored diabetes medication guide compared with the print consumer guides reduces Latino and African American diabetes patients' decisional conflict, through improved knowledge of anti-hyperglycemic medications and satisfaction with information received.

Aim 3: To examine the computer tailored program's effects on participants' changes in medications (medication intensification), self-reported medication adherence and beliefs and A1C levels between baseline and follow-up compared to participants receiving the print consumer guides.

研究设计

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

入排标准

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

入选标准

  • •type 2 diabetes
  • •stated concern about diabetes and diabetes treatment
  • •poor glycemic control
  • •over 21 years of age

排除标准

  • •blind, deaf, otherwise unable to use the telephone or visual resources
  • •currently enrolled in other REACH Detroit research study
  • •in hospice care
  • •current radiation or chemotherapy

研究组 & 干预措施

Traditional CERSG Arm

Active Comparator

CHWs will provide and review with patients language-appropriate versions of the AHRQ consumer guides. CHWs will highlight key points on each page, review information on each medication and elicit and address questions. They will use the autonomy enhancing, motivational-interviewing based skills. As with the first arm, CHWs will schedule follow-up clinic appointments for participants who note a specific treatment change they would consider and will call participants two times after the session at three and six weeks to address additional questions and to follow up on any goals the participant set.

干预措施: Community Health Worker Diabetes Education: Print media (Behavioral)

Web-Based Materials Arm

Experimental

Participants randomized to this arm will be scheduled within 3 weeks of enrollment to have a one-hour face-to-face session with a CHW who will deliver the ipad platform personally tailored diabetes medication decision aid. Participants will receive a printed tailored preference summary at the completion of this visit. If participants note a specific treatment change they would like to discuss with their providers, the CHW will facilitate scheduling a clinic visit within the next month. Finally, CHWs will call participants two times after the session at 3 and 6 weeks to assess if the participant has additional questions and to follow up on any treatment or other goals the participant set during their session.

干预措施: CHW Diabetes Education: tailored web site (Behavioral)

结局指标

主要结局

Changes in decisional conflict

时间窗: baseline and 3 month post intervention

We will be measuring subjects' perceptions of: a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

次要结局

  • Medication adherence and intensification(baseline and 3 month post intervention)

研究者

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

Rebecca Mase

Project Manager

University of Michigan

研究点 (1)

Loading locations...

相似试验