Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Trisha Greenhalgh
ORCID ID
Contact details
University College London
403 Holborn Union Building
Highgate Hill
London
N19 5LW
United Kingdom
+44 (0)20 7288 3246
p.greenhalgh@pcps.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SDO/111/2005
Study information
Scientific title
The POSEIDON trial: Promoting cOllaborative Support and Education in Diabetes for minOrity ethNic groups
Acronym
POSEIDON
Study hypothesis
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
Local Research Ethics Committee (LREC) approval from East London and City on the 9th Nov 2005 (ref: LREC 05/Q0604/142).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Patient information can be found at: http://www.newhamuniversityhospital.co.uk/poseidon/page1/assets/Patient%20Leaflet%202%20English.pdf
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/09/2006
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
240
Participant exclusion criteria
1. Inability to give informed consent
2. Inability of unwillingness to do group work
Recruitment start date
01/09/2006
Recruitment end date
31/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
N19 5LW
United Kingdom
Sponsor information
Organisation
NHS Service Delivery and Organisation (NHS SDO) Programme (UK)
Sponsor details
London School of Hygiene & Tropical Medicine
99 Gower Street
London
WC1E 6AZ
United Kingdom
+44 (0)20 7612 7958
Phillip.Restarick@lshtm.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Service Delivery and Organisation (NHS SDO) Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
2009 results in http://www.netscc.ac.uk/hsdr/files/project/SDO_FR_08-1504-111_V01.pdf
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 protocol in https://www.ncbi.nlm.nih.gov/pubmed/15774990?dopt=AbstractPlus
2. 2011 results in https://www.ncbi.nlm.nih.gov/pubmed/20739577
Publication citations
-
Greenhalgh T, Collard A, Begum N, Sharing stories: complex intervention for diabetes education in minority ethnic groups who do not speak English., BMJ, 2005, 330, 7492, 628, doi: 10.1136/bmj.330.7492.628.