Table 1 World Health Organization Trial Registration Data Set
Item | |
|---|---|
Primary Registry and Trial Identifying Number | International Standard Randomised Controlled Trial Number, ISRCTN23474120 |
Date of Registration in Primary Registry | 05/04/2018 |
Secondary Identifying Numbers | NA |
Source(s) of Monetary or Material Support | This project is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Increasing uptake of effective self-management education programmes for type 2 diabetes in multi-ethnic primary care settings RP-PG-1212-20,004). |
Primary Sponsor | University of Leicester uolsponsor@le.ac.uk |
Secondary Sponsor(s) | NA |
Contact for Public Queries | Professor Melanie Davies Principal Investigator Diabetes Research Centre, University of Leicester, Leicester, UK. |
Contact for Scientific Queries | Professor Melanie Davies Principal Investigator Diabetes Research Centre, University of Leicester, Leicester, UK. |
Public Title | Evaluating the impact of increasing uptake of self-management education programmes for Type 2 Diabetes in primary care: A wait-list cluster randomised controlled trial |
Scientific Title | Evaluating the impact of increasing uptake of self-management education programmes for Type 2 Diabetes in primary care: A wait-list cluster randomised controlled trial |
Countries of Recruitment | UK |
Health Condition(s) or Problem(s) Studied | Type 2 Diabetes |
Intervention(s) | Intervention – Embedding Package It comprises four key components: 1. clear marketing strategy for SSME; 2. user friendly and effective referral pathways; 3. new/amended roles including a local clinical champion and an ‘Embedder’; 4. toolkit of resources (for patients, HCPs and other key stakeholders). Control – Usual Care Eeach practice will continue to provide their usual activities related to SSME whilst in the control period. |
Key Inclusion and Exclusion Criteria | Patient Inclusion criteria: registered at a participating practice; aged ≥18 years old; coded in their primary care medical record as diagnosed with T2DM before or during the step (to be re-assessed at each data extraction point). Patient exclusion criteria: coded in their primary care medical records as having a terminal illness, housebound or in residential care; a dissent code in their primary care medical records for researcher to access clinical data. See eligibility section for full inclusion/exclusion for all parts of the study. |
Study Type | Type of study - interventional Method of allocation – cluster randomised Masking – none Assignment – wait list study, practices randomised 1:1 to immediate intervention or to wait Purpose – improve outcomes |
Date of First Enrolment | First practice 06/08/2018 |
Target sample size | 66 practices 2050 participant questionnaires |
Recruitment status | As of 02/10/19 66 practices recruited, 1920 questionnaires returned |
Primary outcome(s) | HbA1c |
Key secondary outcomes | Referral and uptake rates to SSME |