Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/07/2006
Date assigned
17/01/2007
Last edited
10/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.newhamuniversityhospital.nhs.uk/poseidon

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

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 measures

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

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

http://www.sdo.lshtm.ac.uk/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15774990

Publication citations

  1. 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.

Additional files

Editorial Notes