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Clinical Trials/ISRCTN16863160
ISRCTN16863160
Completed
未知

A randomised controlled trial to investigate the effect of structured education on people at high risk of cardiovascular disease

niversity of Leicester0 sites212 target enrollmentApril 26, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Specialty: Cardiovascular disease, Primary sub-specialty:
Sponsor
niversity of Leicester
Enrollment
212
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Registry
who.int
Start Date
April 26, 2016
End Date
December 31, 2018
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Leicester

Eligibility Criteria

Inclusion Criteria

  • 1\. Aged 40­\-74 years old inclusive
  • 2\. Prescribed statin medication for primary prevention of CVD that is still active, at least 12 months prior to enrolment
  • 3\. TC level \=5\.0 mmols/L at enrolment
  • 4\. Ability to speak and read English to participate effectively in the group education programme
  • 5\. Willing and able to attend the education sessions and clinic visits
  • 6\. Willing and able to give informed consent
  • 7\. Willing to allow GP to be notified of participation in the study, so access post­consent to relevant medical records can be obtained
  • 8\. Have access to a mobile phone to receive text messages

Exclusion Criteria

  • 1\. Under 40 years of age and 75 years and over
  • 2\. Unable or unwilling to give informed consent
  • 3\. Pre­existing CVD
  • 4\. Total cholesterol \< 5 mmol/l
  • 5\. Inherited lipid disorder
  • 6\. Established Type 1 or Type 2 diabetes
  • 7\. Females who are pregnant (self ­reported)
  • 8\. Currently participating or participated in another clinical intervention study in the past 12 weeks

Outcomes

Primary Outcomes

Not specified

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