Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2012
Date assigned
27/04/2012
Last edited
20/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Christopher Bunn

ORCID ID

Contact details

Wolfson Diabetes Endocringology Clinic
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
-
christopher.bunn@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6521

Study information

Scientific title

RAPSID: Can peer supprt, delivered as a group or individual intervention, enable people with diabetes and improve their health? A RAndomised controlled trial of Peer Support In type 2 Diabetes

Acronym

RAPSID

Study hypothesis

RAPSID is a 12 month randomised controlled study among 1200 people with Type 2 diabetes across Cambridgeshire and neighbouring counties, assessing the effect of peer support (that is support by other people with diabetes) on metabolic control (eg glucose, weight, blood pressure). Measures of self management, beliefs and quality of life will be included. The trial includes 4 groups: all receive special educational information, 25% also receive 1:1 peer support, 25% group support and 25% both group and peer support. The peers will be trained and monitored in their work and will be supported by a nurse who will link them with GP/diabetes services if needed.

The RAPSID study is based on a fully evaluated pilot which included (i) Formative evaluation in existing groups to assist with the peer support design (ii) discussions with other global groups about the design and (iii) a full pilot of the three interventions.

The Main Trial commenced with a mail survey of barriers to care to understand who volunteers to come into the trial and to identify potential peers along with an invitation to participate. Randomisation is by geographical area.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=6521

Ethics approval

10/H0308/72

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Type 2, Not Assigned; Disease: Diabetic Control

Intervention

Peer support, support by others with diabetes; Follow Up Length: 12 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

HbA1c; Timepoint(s): 6 and 12 months

Secondary outcome measures

1. Blood pressure (BP) and lipids; Timepoint(s): 6 and 12 months
2. EQ5D quality of life; Timepoint(s): 6 and 12 months

Overall trial start date

04/01/2011

Overall trial end date

30/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female particiants with type 2 diabetes aged between 18 and 80 years.; Target Gender: Male & Female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1200; UK Sample Size: 1200; Description: 4 cells in a 2x2 factorial design-ie 300 in each including 300 controls

Participant exclusion criteria

1. >18 years or <80 years

Recruitment start date

04/01/2011

Recruitment end date

30/11/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Diabetes Endocringology Clinic
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Children's Service
Box No 181
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

American Academy of Family Physicians Foundation Peers for Progress Program

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25785452

Publication citations

Additional files

Editorial Notes