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临床试验/NCT01315756
NCT01315756已完成早期 1 期

The Norwegian Study in Renewing Health: Stimulating Self-management in Patients With Type 2 Diabetes Mellitus Through Telecare With the Few Touch Application and Health Counseling - a Randomized Controlled Trial

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
151
试验地点
2
主要终点
Improved glycemic control, HbA1c

研究概览

简要总结

It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the patients as active players, will improve diabetes self-management reflected by improved glycemic control and lipids, self-care behaviours and lifestyle changes such as improved dietary habits and increased physical activity, compared with usual care. Following this; it is also hypothesized that this will also lead to a reduction in overall risk for diabetes complications (expressed by reduction in e.g., 5 year absolute risk for coronary artery disease as calculated using the Swedish National Diabetes Register's risk calculator) and in the prevalence of the metabolic syndrome (e.g., as defined by the International Diabetes Federation). It also hypothesized that health counselling based on TTM and CBT by a diabetes nurse, and with individualized feedback via sms from the diabetes nurse, may have an important function as a supplement to the self-help system (FTA). In addition, it is hypothesized that the patients' health status and diabetes-related quality of life (HRQL) will improve. The results of this study may show that a commonly used tool like the mobile phone, and also mobile phone together with health counselling, fitted into the patients' daily life, is more effective and cost-effective than standard care.

详细描述

The purpose of this study is to examine the effectiveness of mobile phone-based lifestyle tools, and health counseling using tailored SMS and individual phone-calls to the patients, for self-management of T2DM. Maintaining daily symptom diaries (described below) by an easy way of self-monitoring appear to offer a valid and reliable way of assessing behaviours. In addition, the patients are able to view their own registrations on the Smartphone, i.e. a programmable mobile phone with a touch sensitive screen. The self-help system, called the "Few Touch application", recently tested on 12 people with T2DM at NST, University Hospital of North Norway (UNN), will form the basis for the patients' mobile interaction system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Age >18; diagnosed T2DM > 3 months prior to study inclusion; in case the patient is receiving one or more glucose lowering drug (e.g., metformin, sulphonylurea, glinide, α-glucosidase inhibitor, DPP-IV inhibitor, GLP-1 analogue, glitazone, insulin) the treatment should be stabilized (i.e., no change in dosage the last three months prior to inclusion except for insulin treated patients who are allowed ±15% dose adjustment; HbA1c >7%; capability of understanding and filling in Norwegian questionnaires; be able to use the system provided; be cognitive able to participate.

排除标准

  • 未提供

研究组 & 干预措施

Control group

No Intervention

Treatment as usual.

Few Touch Application (FTA)

Experimental

This arm will receive a Smartphone with the diabetes diary application ("the Few Touch application"), a self-help tool that consists of five main elements accessible to the user.

干预措施: Use of Few Touch Application (FTA) (Device)

FTA and health counseling

Experimental

This arm will additionally receive health counseling based on TTM and CBT by a diabetes nurse with individualized feedback via sms from the diabetes nurse which is based on the patient's initiative (via sms). In addition, the diabetes nurse will call the patients three times during this period and discuss progress.

干预措施: Use of FTA and health counseling based on TTM and CBT (Device)

结局指标

主要结局

Improved glycemic control, HbA1c

时间窗: One year

It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the patients as active players, will improve diabetes self-management reflected by improved glycemic control.

次要结局

  • Lipids, self-care, lifestyle changes, complications, quality of life.(One year)

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

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