Embedding Diabetes Education (RCT)

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN23474120
• Lead Sponsor: niversity of Leicester

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-05
• Study Completion: 2022-02-28
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2308

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

Patient inclusion criteria:
1. Meet all of the above patient eligibility criteria
2. Is able to attend the practice unaided or with a carer or support (applicable to observations of consultations only)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified