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Clinical Trials/ISRCTN23474120
ISRCTN23474120
Completed
N/A

Evaluating the impact of an intervention to increase uptake of self-management education programmes for type 2 diabetes in primary care: a wait-list cluster randomised controlled trial

niversity of Leicester0 sites2,308 target enrollmentApril 5, 2018
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Leicester
Enrollment
2308
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31699046 protocol (added 11/11/2019) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38664727/ (added 26/04/2024)

Registry
who.int
Start Date
April 5, 2018
End Date
February 28, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Leicester

Eligibility Criteria

Inclusion Criteria

  • •Patients – data extraction and mail\-out:
  • •All patients registered at a participating practice and meeting the following eligibility criteria will have pseudonymised one line per patient data extracted, and will be mailed an invitation pack which includes an invitation letter, PIS and questionnaire booklet. The questionnaire booklet contains a self\-report questionnaire and a consent form which gives patients the option to have their questionnaire responses linked to their attendance data in their practice and Provider records.
  • •Patient inclusion criteria:
  • •1\. Registered at a participating practice
  • •2\. Aged \=18 years old
  • •3\. Coded in their primary care medical record as diagnosed with T2DM before or during the study period (to be reassessed at each data extraction point)
  • •4\. Willing and able to provide informed consent (Applicable to optional consent form and questionnaire booklet only)
  • •5\. Able to understand written English to a level sufficient to enable an understanding of the research and their participation within it (applicable to optional consent form and questionnaire booklet only)
  • •Patients – ethnographic sub\-study:
  • •Patients who express an interest to participate in the ethnographic sub\-study and meet the following eligibility criteria will be eligible for the ethnographic sub\-study

Exclusion Criteria

  • •Practice exclusion criteria:
  • •1\. Unable to make contact with practice manager or equivalent
  • •Patient exclusion criteria \- data extraction and mail\-out:
  • •1\. Coded in their primary care medical records as having a terminal illness
  • •2\. Coded in their primary care medical records as housebound or in residential care
  • •3\. A dissent code in their primary care medical records for researcher to access clinical data
  • •Patient exclusion criteria \- ethnographic sub\-study:
  • •1\. Unable to understand spoken English to a level sufficient to enable an understanding of the research and their participation within it
  • •Stakeholder exclusion criteria:
  • •1\. Unable to understand written and spoken English to a level sufficient to enable an understanding of the research and their participation within it

Outcomes

Primary Outcomes

Not specified

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