Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/06/2017
Date assigned
07/07/2017
Last edited
07/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Diabetes is a serious and progressive disease that causes blood sugar levels to be uncontrolled. This can lead to complications like heart attacks, stroke, kidney failure, and a shorter span of life. Managing diabetes well is the key to living a healthy life and self-management education programmes are the best way to gain the knowledge and skills necessary to live well with diabetes. So our study is particularly relevant to anyone with diabetes, as well as the general public. There is good evidence that diabetes education works well. The aim of this study is to increase the number of people with type 2 diabetes who go to self-management education programmes by testing the components of an embedded package of diabetes education.

Who can participate?
Medical practices, and primary care stakeholders involved in the provision of diabetes structured education. Patients aged 18 and older who are diagnosed with type 2 diabetes.

What does the study involve?
Participating centres receive an ‘Embedding package’ which is an online resource given to practices for a six month period. This includes a clear marketing strategy, user friendly and effective referral pathways, new and amended roles including a local clinical champion and a toolkit of resources for patients, healthcare professionals and other key stakeholders. Eligible patients are asked to complete questionnaires, take part in observations and interviews relating to structured diabetes education and provide consent to access medical information.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.

Where is the study run from?
This study is being run by the University of Leicester (UK) and takes place in seven medical centres/hospitals in the UK.

When is the study starting and how long is it expected to run for?
May 2012 to January 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Kyla Harrington
kyla.harrington@uhl-tr.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Kyla Harrington

ORCID ID

Contact details

University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
+44 116 258 4180
kyla.harrington@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34445

Study information

Scientific title

Increasing uptake of self-management education programmes for Type 2 Diabetes in multi-ethnic primary care settings: A feasibility study

Acronym

Study hypothesis

The aim of this feasibility study is to test the components of the Embedding Package intervention prior to conducting a stepped wedge randomised controlled trial.

Ethics approval

Yorkshire & The Humber – Leeds West Research Ethics Committee, 03/05/2017, ref: 17/YH/0135

Study design

Non-randomised; Both; Design type: Prevention, Education or Self-Management, Qualitative

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Diabetes, Primary sub-specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus

Intervention

The Embedding Package is implemented in each practice for a six month period during the feasibility study. An integrated ethnographic element, using observation and semi-structure interviews, are conducted to provide detailed contextually-sensitive data about the process of implementation, sustainability of the change and the ‘fit’ of the Embedding Package within routine practice.

The Embedding Package comprises of four key components which have been collated in to an online resource:
1. A clear marketing strategy
2. User friendly and effective referral pathway
3. New/amended roles including a local clinical champion and an ‘Embedder’
4. Toolkit of resources (for patients, healthcare professionals and other key stakeholders

Packages of support and resources, resources developed in an earlier part of our research project that deals with a wide variety of needs, from training GPs and nurses in how to explain the benefits of diabetes education to improving the way that information about diabetes education is made available in local communities. A skilled person described as an ‘Embedder’ is provided to centres to support practices with ideas and skills. Information from patients with type 2 diabetes and healthcare staff is collected through a variety of different methods, including a patient questionnaire, interviews and observations and pseudonymised electronic patient data. Eligible patient participants are asked to complete a questionnaire, take part in observations and interviews relating to diabetes structured education and provide consent to access medical information.

The information gathered is used to to develop the resources ready for a larger scientific trial in 80 more GP practices around the UK in 2018.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The feasibility and suitability of the components of the Embedding Package within the participating practice and wider host organisations as assessed using ethnographic methods throughout the duration of this feasibility study.

Secondary outcome measures

1. Optimisation of observational methods in a range of contexts for use in the main trial, are assessed using ethnographic methods throughout duration of feasibility
2. The completeness and quality regarding outcomes required for the RCT is assessed using data extracted from primary care by PRIMIS between months 2 and 6 of the feasibility study.
3. Referral and uptake practice level data from providers of SME are assessed for availability at the end of the study
4. Response rate to the questionnaire are recorded as the number of completed questionnaires returned by the end of the recruitment period
5. Patient preferences for the delivery of SME is assessed via the questionnaire responses at the end of the study
6. Consent rate for accessing medical records will be recorded as the number of completed consent forms returned by the end of the recruitment period
7. Costing for the component of the Embedding package will be assessed using a practice level proforma and interviews at the end of the feasibility study period

Overall trial start date

01/05/2012

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Practice Inclusion criteria:
1. Use either EMIS Web or TPP System One (required for data extraction)
2. Located within the participating CCGs
3. Able to refer patients with type 2 diabetes to a structured education programme.
4. Willing to sign a data sharing and remote data collection agreement with PRIMIS allowing the collection of one line per patient anonymised and, where patient consent is given, identifiable data as required for analysis.

Primary Care stakeholder eligibility criteria:
1. Employed by, or involved in the delivery of/or commissioning of any aspect of the Embedding Package at a participating practice/CCG
2. Willing and able to give informed consent (written or verbal)

Patient participant eligibility criteria:
1. Aged ≥18 years old
2. Coded in their primary care medical record as diagnosed with T2DM, before or during the study
3. Registered at a participating practice

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

Practice exclusion criteria:
1. Does not use EMIS Web or TPP System One
2. Located outside of participating CCG
3. Unable to refer patients with type 2 diabetes to a structured education programme
4. Not willing to sign a data sharing and remote data collection agreement with PRIMIS

Primary care stakeholder exclusion criteria:
1. Not employed by or involved in the delivery or commissioning of any aspect of the Embedding Package at participating practice or CCG
2. Not willing or able to give informed consent

Patient participant exclusion criteria:
1. Aged under 18 years old
2. A record of a terminal illness
3. Life expectancy < 12 months
4. Coded in their primary care medical records as housebound or in residential care
5. A dissent code in their primary care medical records to sharing data as part of a research study

Recruitment start date

08/06/2017

Recruitment end date

30/11/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Leicester (Lead site)
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Trial participating centre

St Georges Medical Practice
93 Musters Road West Bridgford
Nottingham
NG2 7PG

Trial participating centre

West Bridgeford Medical Centre
97 Musters Road West Bridgford
Nottingham
NG2 7PX
United Kingdom

Trial participating centre

East Leake Health Centre,
Gotham Road
East Leake
LE12 6JG
United Kingdom

Trial participating centre

Danes Camp Medical Centre
Rowtree Road
Northampton
NN4 0NY
United Kingdom

Trial participating centre

Albany House Medical Centre
Queen Street
Wellingborough
NN8 4RW
United Kingdom

Trial participating centre

Danetre Medical Practice
London Road
Daventry
NN11 4DY
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Research Governance Office
Fielding Johnson Building
University of Leicester
Leicester
LE1 7RH
United Kingdom
+44 116 252 5308
UOLsponsor@leicester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer review journal.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/01/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes