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Telehealth for Diabetes Self-Management

2007年11月13日 更新者:University of Washington

This study will examine the feasibility and short and-long-term efficacy of a web-based telehealth intervention with community-dwelling older adults who have been diagnosed with type 2 diabetes. Effectiveness will be evaluated using multiple measures within three different domains: 1) physical (glycosylated hemoglobin [HbA1C], weight, and lipid levels); 2) behavioral (monitoring blood glucose levels, feet inspections, diet, and exercise frequency), and 3) psychosocial (depression, quality of life, social support, and adjustment to diabetes).

This is a randomized controlled trial of a web-based telehealth intervention designed to improve self-management behaviors in a group of community dwelling older diabetics. Two groups of participants will be recruited and randomized over a four-month period during years 01 and 02. Participants in the control group will receive standard diabetic care provided by their provider. Participants in the intervention group will receive computer training in the participant's home in how to access and utilize the web-based telehealth study webpage. The intervention will consist of a program designed and delivered via the Internet to improve the participants' diabetes self-management behaviors using behavioral and motivational strategies and cues to modify perceptions of self-efficacy and beliefs regarding the ability to affect the progress of the disease and change personal behavior.

研究概览

详细说明

This one year study plans to enroll 62 individuals into two groups. One group will receive the standard diabetic care provided and the second group will receive the standard diabetic care and training on how to use a computer to access the Internet. Participant assignment into either group is random (like flipping a coin). Study procedures will include the completion of questionnaires; a blood pressure reading, weight and a finger prick to obtain a blood sample.

There will be a total of three visits. One visit will occur before the study starts and at a six-month interval during the study period. The time to complete the study procedures by the research staff is approximately 1 to 1½ hours.

  1. Questionnaires: Participants will meet with a research staff person who will ask questions about dietary intake, exercise activity, blood glucose levels, feet inspections, past and current Internet activity, and psychosocial well-being (depression, quality of life, self-efficacy, social support, readiness to change, and adjustment to diabetes). The time estimated for completion is about 45 to 60 minutes.
  2. Physiologic Measures: Participants will have their blood pressures taken, weight measured using a scale, and asked to provide 4-5 drops of blood from the fingertip to measure glycosylated hemoglobin (HbA1c), Cholesterol (HDL:LDL ratio) will be measured to evaluate improvement in short-and-long term (3 months to one year) management of diabetes.
  3. Participants selected to participate in the computer/Internet study group will be contacted by research staff within one month to schedule a time to set-up the study computer equipment and receive computer training. Three 2 hour sessions of computer training over a three-week period in participants' homes will be scheduled. Participants will also be expected to participate in following Internet study procedures, available via the Internet from their homes.

    1. Maintaining a daily personal log of diabetes self care activities (blood sugar readings, diet, exercise, feet inspections, etc.)
    2. Participating in nurse led peer support question and answer chat sessions twice a month.

    d). Read and respond to e-mail sent from the study nurse. e) Read health information on diabetes management, depression, and psychosocial well being that will be provided by the study nurse.

    Computer Training Training will be provided on how to use the computer, access the study web page resources, and participate in the nurse-led peer support group conference forum, use e-mail, and how to prepare and send a daily log of self-management activities (blood sugar monitoring, diet, feet inspections, and exercise). Training will also be provided on how to use the study web site's bulletin board, and the electronic prompt to verify completion of the weekly health reading assignment, and how to develop and post an action plan on-line.

    The amount of time for the above Internet activities will vary depending on participants' degree of interest in accessing the Internet resources provided. Approximately 1-4 hours per week or more will be needed to complete the Internet activities. Participants who are assigned to the intervention group who fail to respond to e-mail or to use any of the intervention resources for a one-week period will be contacted by telephone to determine the reason for not participating in the study activity (technical, knowledge deficit, medical, lack of ability, lack of interest, etc.).

研究类型

介入性

注册 (实际的)

62

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

    • Washington
      • Seattle、Washington、美国、98195
        • University of Washington

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

60年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • diagnosed with Type 2 diabetes (American Diabetes Association criteria), i.e., fasting blood sugar levels of 126 mg/d or non-fasting levels of 200 mg/d when not taking glycemic control medication for diabetes
  • diagnosed with diabetes for at least one year
  • living in a non-institutional home in the community
  • age 60 or older
  • willing to be randomized
  • able to read and write English or have an available caregiver or family member who can provide the necessary language translation.

Exclusion Criteria:

  • moderate to severe cognitive impairment (less than 24 on the Mini Mental State Examination)
  • severe vision impairment (greater than or equal to 9 on the Functional Vision Screening Scale);
  • impairment of Activities of Daily Living (greater than 2 on Katz's Activities of Daily Living Scale);
  • inability to hold and move objects; push buttons or use a trackball or a telephone;
  • the presence of terminal debilitating medical conditions likely to result in death or severe disability prior to completion of the study;
  • severe expressive or receptive communication impairment (inability to communicate will interfere with the administration of outcome measures), or
  • no available phone-line or free electrical outlet

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

  • 主要用途:治疗
  • 分配:随机化
  • 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:1
Subjects randomized into the treatment group received the computer treatment
Web based education format delivered for a six month period

研究衡量的是什么?

主要结果指标

结果测量
大体时间
glycosylated hemoglobin (A1C) levels.
大体时间:one year
one year

次要结果测量

结果测量
大体时间
Study participants who receive the web-based telehealth intervention will have fewer depression symptoms and higher quality of life, social support, at post-test (short-term) than participants in the control group.
大体时间:1 year
1 year
Study participants who receive the web-based telehealth intervention will have fewer depression symptoms and higher quality of life, social support, at the 12 month (long-term) follow-up than participants in the control group.
大体时间:one year
one year

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。

调查人员

  • 首席研究员:Gail E Bond, Ph.D、University of Washington
  • 学习椅:Fredric Wolf, Ph.D、University of Washington
  • 研究主任:Martha Price, DNs、University of Washington
  • 学习椅:Linda Teri, PhD、University of Washington
  • 学习椅:Jerry Palmer、University of Washington

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

2003年9月1日

研究完成 (实际的)

2007年8月1日

研究注册日期

首次提交

2005年9月15日

首先提交符合 QC 标准的

2005年9月15日

首次发布 (估计)

2005年9月19日

研究记录更新

最后更新发布 (估计)

2007年11月14日

上次提交的符合 QC 标准的更新

2007年11月13日

最后验证

2007年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 03-5886-V03
  • 1K01NR008506-03 (美国 NIH 拨款/合同)

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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