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临床试验/NCT04821921
NCT04821921已完成不适用

The Impact of the COVID-19 Pandemic on Diabetes Management (CoDiaM)

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 1,503 人开始时间: 2021年4月9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
1,503
试验地点
1
主要终点
Hemoglobin A1c (HbA1c)

研究概览

简要总结

The "CoDiaM study" examines how diabetes management and outcomes are changing during the COVID-19 pandemic and whether these changes are influenced by socio-demographic factors, health literacy, self-efficacy and perceived social support.

详细描述

The Covid-19 pandemic created new challenges for patients with diabetes and their treating physicians. In order to protect people from SARS-COV-2 infections, social contacts were reduced by restrictions on many areas of social life. As a side effect, these measures could have also led to changes in the self-management of patients with diabetes mellitus, such as lack of physical exercise, less healthy dietary behavior, and a reduced intensity of medical care. These possible changes may be associated with poorer control of blood glucose, cholesterol, and blood pressure. Therefore, the CoDiaM study will investigate how management and outcomes of diabetes are changing during the pandemic and identify associated factors.

The study is based on data of patients treated in three GP practices specialized on diabetes treatment in Hamburg, Germany. Data collection will include a written patient survey and extraction of clinical data from patient records. The patient's survey includes sociodemographic data and validated instruments to assess diabetes self-management (DSMQ), health literacy (HLS-EU-Q16), self-efficacy (General Self-efficacy scale) and perceived social support (F-SozU K14). Data will be analyzed by descriptive statistics and multivariable, multilevel linear and logistic regression analyses adjusted for possible confounders and random effects on the practice level.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • being 18 years or older, and
  • having diabetes type 2 or type 1, and
  • having consulted the practice at least once in 2019 AND at least once in 2020

排除标准

  • no capacity to consent (e.g. because of dementia)
  • insufficient German language skills to understand the questions in the questionnaire
  • not able to fill out the questionnaire (e.g. because of blindness)
  • gestational diabetes

结局指标

主要结局

Hemoglobin A1c (HbA1c)

时间窗: 01.01.2019 to 31.12.2021

Data on outcome will be extracted from the GP's patient record

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

Dr. phil. Ingmar Schäfer

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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