The POSEIDON trial: Promoting cOllaborative Support and Education in Diabetes for minOrity ethNic groups

ISRCTN	ISRCTN68516177
DOI	https://doi.org/10.1186/ISRCTN68516177
Secondary identifying numbers	SDO/111/2005

Submission date: 03/07/2006
Registration date: 17/01/2007
Last edited: 05/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Trisha Greenhalgh
Scientific

University College London
403 Holborn Union Building
Highgate Hill
London
N19 5LW
United Kingdom

Phone	+44 (0)20 7288 3246
Email	p.greenhalgh@pcps.ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Patient information can be found at: http://www.newhamuniversityhospital.co.uk/poseidon/page1/assets/Patient%20Leaflet%202%20English.pdf
Scientific title	The POSEIDON trial: Promoting cOllaborative Support and Education in Diabetes for minOrity ethNic groups
Study acronym	POSEIDON
Study objectives	Informal story-sharing groups led by bilingual health advocates in the patient's own language will be no less effective than standard nurse led diabetes education through an interpreter, on clinical, biochemical and psychometric outcomes in minority ethnic groups with diabetes.
Ethics approval(s)	Local Research Ethics Committee (LREC) approval from East London and City on the 9th Nov 2005 (ref: LREC 05/Q0604/142).
Health condition(s) or problem(s) studied	Diabetes mellitus
Intervention	The intervention will have three components: 1. Professional development groups for Bilingual Health Advocates (BHAs) using a validated learning set model (in which stories about clients with diabetes form the basis of facilitated group discussion). 2. Story-sharing groups led by a BHA with support from a Diabetes Specialist Nurse (DSN). Stories about living with diabetes will form the basis of group discussions. 3. Organisational support for establishing these groups, including development and mainstreaming of patient pathways, data management, and information systems. The comparison will be referral to traditional NHS education sessions (e.g. routine nurse led education groups in either primary or secondary care, or one to one education via General Practitioner [GP] or in hospital clinic) with an interpreter if needed.
Intervention type	Other
Primary outcome measure	United Kingdom Prospective Diabetes Study (UKPDS-2) cardiovascular risk score (a composite of blood pressure, smoking status, lipid ratio, presence of atrial fibrillation, and HbA1c)
Secondary outcome measures	1. HbA1c 2. Well-being 3. Self-management skills 4. Diabetes-related actions 5. Cardiovascular events
Overall study start date	01/09/2006
Completion date	31/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	240
Key inclusion criteria	1. 240 people with diabetes mellitus (either form) aged over 18 2. Referred (or self-referred) for diabetes education 3. Speak one of the languages in which story-sharing groups are offered that is, Urdu, Sylheti, Tamil, Somali, or English (for African-Caribbeans)
Key exclusion criteria	1. Inability to give informed consent 2. Inability of unwillingness to do group work
Date of first enrolment	01/09/2006
Date of final enrolment	31/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London

London
N19 5LW
United Kingdom

Sponsor information

NHS Service Delivery and Organisation (NHS SDO) Programme (UK)
Government

London School of Hygiene & Tropical Medicine
99 Gower Street
London
WC1E 6AZ
United Kingdom

Phone	+44 (0)20 7612 7958
Email	Phillip.Restarick@lshtm.ac.uk
Website	http://www.sdo.lshtm.ac.uk/
"ROR"	https://ror.org/02wnqcb97

Funders

Funder type

Government

NHS Service Delivery and Organisation (NHS SDO) Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	2009 results in http://www.netscc.ac.uk/hsdr/files/project/SDO_FR_08-1504-111_V01.pdf
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	19/03/2005		Yes	No
Results article	results	01/01/2011		Yes	No

Editorial Notes

05/07/2018: Publication reference added and report link added to publication and dissemination plan.