Contact information
Type
Scientific
Primary contact
Dr Susan M Smith
ORCID ID
Contact details
University of Dublin
Department of Public Health and Primary Care
Trinity College Centre for Health Sciences
AMiNCH
Tallaght
Dublin 24
-
Ireland
-
susmith@tcd.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Peer support in type two diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses
Acronym
Study hypothesis
Peer support improves the biophysical and psychosocial outcomes in patients with type two diabetes and is cost effective.
Article in Diabetes Voice, a magazine of the International Diabetes Federation: http://www.diabetesvoice.org/issues/2005-12/Can_a_peer-care_model_improve_diabetes_outcomes.pdf
Ethics approval
Ethical approval has been obtained from the Ethics Committee of the Irish College of General Practitioners on the 1st December 2004 (ref: REC0904-11).
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Type 2 diabetes
Intervention
Intervention practices deliver a peer support intervention. This is a complex intervention with the following components:
1. Peer support workers: three peer supporters are identified and are recruited by the general practitioners (GP) and practice nurses in each intervention practice. Eligibility is based the following criteria:
1.1. They have had type two diabetes for at least a duration of one year
1.2. They participate in preventive treatments and generally adhere to treatment and behaviour change regimens, as judged by the practice team
1.3. They have a capacity and commitment to undergo the training required (outlined below)
1.4. They have a full understanding of the importance of patient confidentiality
1.5. They undertake to liaise with the practice nurse and/or GP if unanticipated problems arise during the course of their peer support activity
1.6. Peer support workers will receive a travel and expenses grant each year
2. Peer support training: peer support workers will be trained by the research team. They will attend two sessions delivered locally. The training will prepare them to provide peer support rather than formal diabetes education. During the training, the peer supporters will be familiarised with the materials designed for the group meetings between peers. They will also be presented with guidance on how to manage groups and how to handle potential problems that arise.
3. Peer support group meetings: the groups meet nine times in the two years of the intervention. Sessions are semi-structured and based on diabetes-related topics. Peer supporters will be provided with a pack outlining the suggested topic and content for each session with materials to be distributed to the group. Each session will conclude with the group identifying questions that they would like addressed. These will be fed back to the research team, who will provide answers to be discussed at the beginning of the next session.
4. Ongoing management of the peer support system: the project manager will make contact with the peer support workers following each session by telephone and they will also be invited to attend an annual meeting to facilitate communication between peer support workers. This will also encourage retention of peer support workers over time.
The control group is not getting a specific intervention but we are introducing a standardised primary diabetes care system across all the practices (intervention and control). This will involve the following:
All participating practices are trained and supported to introduce a standardised primary diabetes care system. This is to avoid the lack of clarity that can result if usual care is used for the control arm of a randomised controlled trial. This diabetes care system includes:
1. Practice based training for GPs and practice nurses
2. Agreement and implementation of evidence-based clinical guidelines
3. Structured registration and recall every four months of patients with type two diabetes to specific diabetes appointments or mini-clinics with practice nurses supported by GPs
4. Provision of treatment algorithms designed to optimise glycaemic control and reduce cardiovascular risk
5. Use of a target card, a patient-held record of results relating to their diabetes
6. Educational resources
7. Annual practice audit
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Blood pressure
2. Total cholesterol
3. Haemoglobin A1c (HbA1c)
4. Wellbeing score
Secondary outcome measures
1. Biophysical: body mass index (BMI)
2. Measure of processes of care:
2.1. GP visits
2.2. Practice nurse visits
2.3. Hospital outpatient department (OPD) visits
2.4. Hospital diabetes centre visits
2.5. Hospital admissions
3. Psychosocial measures and level of adherence:
3.1. Diabetes self-care activities
3.2. Self-efficacy
3.3. Measure of medication adherence
3.4. Smoking
4. Medication: e.g., aspirin
Overall trial start date
01/04/2005
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
A patient is eligible to participate if they:
1. Are over 18 years of age
2. Have type two diabetes
3. Attend participating practices
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
410 patients from 20 practices
Participant exclusion criteria
A patient will be excluded if they have significant mental or physical illness which is likely to impair their capacity to participate in the programme.
Recruitment start date
01/04/2005
Recruitment end date
01/04/2010
Locations
Countries of recruitment
Ireland
Trial participating centre
University of Dublin
Dublin 24
-
Ireland
Sponsor information
Organisation
Health Research Board (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin 2
-
Ireland
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board (Ireland)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
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
1. 2007 pilot study and protocol in: https://www.ncbi.nlm.nih.gov/pubmed/17672892
2. 2007 results [Development of a complex intervention to test the effectiveness of peer support in type 2 diabetes.] in: https://www.ncbi.nlm.nih.gov/pubmed/17764549
3. 2011 results [Peer support for patients with type 2 diabetes: cluster randomised controlled trial] in: http://www.ncbi.nlm.nih.gov/pubmed/21324992
Publication citations
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Pilot study and protocol
Paul GM, Smith SM, Whitford DL, O'Shea E, O'Kelly F, O'Dowd T, Peer support in type 2 diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses: pilot study and protocol., BMC Fam Pract, 2007, 8, 45, doi: 10.1186/1471-2296-8-45.
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Results
Smith SM, Paul G, Kelly A, Whitford DL, O'Shea E, O'Dowd T, Peer support for patients with type 2 diabetes: cluster randomised controlled trial., BMJ, 2011, 342, d715.
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Results
Paul G, Smith SM, Whitford D, O'Kelly F, O'Dowd T, Development of a complex intervention to test the effectiveness of peer support in type 2 diabetes., BMC Health Serv Res, 2007, 7, 136, doi: 10.1186/1472-6963-7-136.