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Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management (T+)

2012年4月9日 更新者:Justine Baron、University College London Hospitals

Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes

New telemedicine systems have been designed to assist people suffering from diabetes in the management of their chronic disease. More recently the focus has been moving to portable systems equipped with Bluetooth. This study consists of evaluating an application called the Think Positive (T+) diabetes management software. It is a randomized controlled trial designed to compare, over a nine month period, a group of patients receiving usual care with a group of patients using the T+ system. The objectives of the study are to investigate the extent to which this telemedicine application helps patients control their blood sugar levels (HbA1c), as well as the extent to which its users consider it to be acceptable. The impact of its use on factors such as diabetes self-care, health status, quality of life, self-confidence in diabetes management, fear of hypoglycemia and illness representations will also be examined. Because of the supplementary real-time support and feedback that T+ offers, its use should lead to better outcomes in diabetes management than usual care does.

研究概览

研究类型

介入性

注册 (实际的)

86

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

      • London、英国、W1W 7EJ
        • University College London (UCL)

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

18年 及以上 (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:

  • Type 1 and type 2 diabetes patients
  • Insulin requiring patients
  • Sufficiently fluent in english
  • HbA1c > 7.5
  • Last visit with Diabetes Specialist Nurse (DSN) < 12 months

Exclusion Criteria:

  • Psychiatric disorders
  • Poor vision or/and lack of manual dexterity
  • Prior use of T+
  • Participation in another ongoing trial
  • Patients with antenatal/gestational
  • Patients who are in transition between the children services and adult services Insulin pump users

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:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:T+ Intervention
The intervention group patients will use the T+ telemedicine application whilst completing repeated measures aiming to compare them to a control group receiving standard care.
T+ consists of the Glucometer paired with a cradle that transmits via Bluetooth blood glucose results to a mobile phone. Data is stored and sent to a secure website. The website can be accessed by the patient as well as by health care providers (HCP). HCP can discuss data on the phone and make recommendations via text messages to patients. Visual feedback (graphs and statistics) illustrating recent blood sugar levels patterns is automatically and immediately sent to the patient when data is transferred from the T+ phone.
无干预:Usual care
The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Blood sugar levels (HbA1c)
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months

次要结果测量

结果测量
措施说明
大体时间
BMI
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Number of Hypoglycemic events
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Blood pressure
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Diabetes self-care
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Diabetes self- efficacy
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Quality of life
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Health status
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Illness representations
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
User acceptability of T+
大体时间:3 months, 9 months
3 months, 9 months
Nurses' Perceptions of T+
大体时间:Baseline, 3 months, 9 months
Baseline, 3 months, 9 months
Self efficacy in using T+
大体时间:3 months, 9 months
3 months, 9 months
Health care utilization
大体时间:baseline, 3 months, 9 months
baseline, 3 months, 9 months
Self management
大体时间:baseline, 3 months, 9 months
2 subscales of the HeiQ questionnaire.
baseline, 3 months, 9 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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2010年6月1日

初级完成 (实际的)

2011年11月1日

研究完成 (实际的)

2011年11月1日

研究注册日期

首次提交

2009年6月16日

首先提交符合 QC 标准的

2009年6月16日

首次发布 (估计)

2009年6月17日

研究记录更新

最后更新发布 (估计)

2012年4月10日

上次提交的符合 QC 标准的更新

2012年4月9日

最后验证

2012年4月1日

更多信息

与本研究相关的术语

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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