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临床试验/NCT03950219
NCT03950219Unknown不适用

CUlturally Sensitive TOols and Methods for Ethnic Minorities (CUSTOM): Building Bridges Between Theory and Practice in Diabetes Self-management Education and Support

Steno Diabetes Center Copenhagen1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
309
试验地点
1
主要终点
Well-being

研究概览

简要总结

The CUSTOM research project represents a complex intervention. The project aim of the intervention is, through the delivery of culturally sensitive Diabetes self-management education and support, to support ethnic minorities with type 2 diabetes in making health-promoting decisions about their care and gaining insight into their goals, values and motivation to improve their daily diabetes self-management. The target group comprises ethnic minorities whose native language is Arabic, Urdu or Turkish.

详细描述

The CUSTOM research project represents a complex intervention. The project aim of the intervention is, through the delivery of culturally sensitive DSMES, to support ethnic minorities with type 2 diabetes in making health-promoting decisions about their care and gaining insight into their goals, values and motivation to improve their daily diabetes self-management. The target group comprises ethnic minorities whose native language is Arabic, Urdu or Turkish. The intervention has been developed in collaboration with the target group and health care professionals from Centre for Diabetes (CfD) in Copenhagen Municipality.

CUSTOM will explore feasibility and effectiveness of the intervention including the mechanisms through which outcomes occur and contexts where outcomes are likely to be replicable. The intervention builds on the framework of complex interventions(26), and is designed as an pragmatic randomised controlled trial in three arms.

Focus on fidelity, appropriateness and acceptability of the developed intervention.

  • What factors and structures are necessary to facilitate DSMES access and retention among the target group?
  • Which methods and tools supporting diabetes decision making and problem solving are acceptable and feasible among the target group?
  • What educational strategies promote Health Care Professionals' (HCPs') communication with the target group?

Focus on exploring effectiveness of the intervention, the mechanisms through which outcomes occur and contexts where outcomes are likely to be replicable.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Clinical diagnosis of type 2 diabetes
  • Ability to give written consent
  • Ability and willingness to attend and participate in a group-based education programme.
  • First language is Arabic, Turkish or Urdu.

排除标准

  • Physical illness that could seriously reduce their life expectancy and ability to participate in the trial
  • Mental illness that could reduce their ability to participate in the trial
  • Significant alcohol or substance misuse which could limit the participants ability to participate in the trial
  • A primary diagnosis of learning disability
  • Pregnancy, breastfeeding or plans of pregnancy during the study period

结局指标

主要结局

Well-being

时间窗: 6 months

questionnaire

diabetes self-management

时间窗: 6 months

questionnaire

HbA1c

时间窗: 6 months

blood sample

次要结局

未报告次要终点

研究者

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

Nana Folmann Hempler

Team leader and senior researcher

Steno Diabetes Center Copenhagen

研究点 (1)

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