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临床试验/ISRCTN11913581
ISRCTN11913581已完成未知

Implementation of a contextualized self-management approach to prevent and manage type 2 diabetes

European Commission0 个研究点目标入组 712 人开始时间: 2017年1月10日最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
712

研究概览

简要总结

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29550780 protocol 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32265775 results (added 09/04/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36162865/ Process evaluation (added 27/09/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36962331/ (added 27/03/2023)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Inclusion criteria as of 01/10/2018:
  • 1. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrolment
  • 2. Aged between 30 – 75 years
  • 3. Have no plans of migrating out of the study area over the next 12 months from the date of enrolment
  • 4. Able to provide written informed consent
  • 5. Agree to home visits and follow-up contacts as part of study participation
  • 6. Have not been previously diagnosed with diabetes for longer than 12 months
  • 7. Have a positive confirmatory test of pre-diabetes or diabetes
  • Previous inclusion criteria:
  • 1. Current residents who have resided in their respective communities for at least 6 months prior to enrolment into the study
  • 2. Aged 30 – 75 years
  • 3. Able to provide written informed consent
  • 4. Agree to allow home visits or follow-up contacts as part of participating in the trial
  • 5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start. In Sweden, this includes high risk of diabetes based on FINDRISC scores.
  • Previous inclusion criteria as of 16/10/2017:
  • 1. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrollment
  • 2. Aged between 30 – 75 years
  • 3. Have no plans of migrating out of the study area over the next 12 months from the date of enrollment
  • 4. Able to provide written informed consent
  • 5. Agree to home visits and follow-up contacts as part of study participation
  • 6. Have not been previously diagnosed with diabetes for longer than 12 months
  • 7. Have a positive confirmatory test of pre-diabetes or diabetes
  • Previous inclusion criteria:
  • 1. Current residents who have resided in their respective communities for at least 6 months prior to enrollment into the study
  • 2. Aged 30 – 75 years
  • 3. Able to provide written informed consent
  • 4. Agree to allow home visits or follow-up contacts as part of participating in the trial
  • 5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start

排除标准

  • Current exclusion criteria as of 16/10/2017:
  • 1. Pregnancy
  • 2. Serious mental disability
  • Previous exclusion criteria:
  • 1. Currently known to be pregnant
  • 2. Plans of migrating out of the study area over the next 12 months from the date of enrollment into the study
  • 3. Previous diagnosis of diabetes, 12 months prior to enrollment into the study

研究者

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