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临床试验/NCT04935554
NCT04935554已完成不适用

My Type 2 Diabetes: Person-centred Health Care

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Change in Glycated haemoglobin (HbA1c) from baseline until week 12

研究概览

简要总结

The Type 2 diabetes (T2D) project is a research and innovation project that will create a new comprehensive, participant-centered service model for interaction, increased physical activity, self-management, distance monitoring and lifestyle change for patients with type 2 diabetes. Central to the degree of innovation is a new model for interaction and use of technology for distance monitoring and coping.

详细描述

Type 2 diabetes is both physically and mentally stressful. At the same time, it requires a high individual effort, which can be demanding. Good mental health is necessary to be able to manage and control diabetes in a healthy and effective way. Therefore, we want to create an offer that takes care of the whole person, and physically as well as mentally.

Personal follow-up Based on surveys and conversations, the study participant and a contact person will prepare a 12-week plan that will be implemented with self-measurements and follow-up from the contact person. The plan will consist of the activities that best suit the participant's needs. It can be physical activity, diet course, health competence, motivation and psychosocial intervention that will be useful for the participant. After 12 weeks, the implementation will be evaluated.

Several new technological solutions are developed and will be used during the project period. A digital tool for mapping of the individuals needs will be an important part of the survey that is done during start-up. Activity clocks will be used for measuring steps, heart rate, and number of personalized activity index (PAI). An online portal for communication and interaction will make information easily accessible to users, simplify distance follow-up and communication flow.

The intervention will take place at two Healthy Life Centres. A Healthy Life Centre is an interdisciplinary primary health care service which offers effective, knowledge-based measures for people with, or in high risk of disease, who need support in health behaviour change and in coping health problems and chronic disease.

The Healthy Life Centre is part of the public health care service in the municipality. Healthy Life Centre programs have a patient centred approach and aim at strengthening the individual's control of his or her own health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes

排除标准

  • Unstable cardiovascular disease
  • Severe chronic obstructive pulmonary disease (COPD)

结局指标

主要结局

Change in Glycated haemoglobin (HbA1c) from baseline until week 12

时间窗: Baseline and week 12

Glycated haemoglobin (HbA1c) is a measurement of the three-month average blood sugar level and HbA1c is an important outcome measure in diabetes clinical trials.

次要结局

  • Change in waist circumference from baseline until week 12(Baseline and week 12)
  • Change in physical fitness by the number of personalized activity index (PAI) from baseline until week 12(Baseline and week 12)
  • Change in mental health by questionnaire Symptom Checklist-90-R (SCL-90-R) until week 12(Baseline and week 12)
  • Health competence(Baseline and week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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My Type 2 Diabetes: Person-centred Health Care | 临床试验