Peer support in type two diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses
| ISRCTN | ISRCTN42541690 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42541690 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/06/2006
- Registration date
- 26/07/2006
- Last edited
- 04/10/2017
- 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
Contact information
Dr Susan M Smith
Scientific
Scientific
University of Dublin
Department of Public Health and Primary Care
Trinity College Centre for Health Sciences
AMiNCH
Tallaght
Dublin 24
-
Ireland
| susmith@tcd.ie |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Peer support in type two diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses |
| Study objectives | 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(s) | Ethical approval has been obtained from the Ethics Committee of the Irish College of General Practitioners on the 1st December 2004 (ref: REC0904-11). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2005 |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 410 patients from 20 practices |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- Ireland
Study participating centre
University of Dublin
Dublin 24
-
Ireland
-
Ireland
Sponsor information
Health Research Board (Ireland)
Government
Government
73 Lower Baggot Street
Dublin 2
-
Ireland
| Website | http://www.hrb.ie |
|---|---|
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
Health Research Board (Ireland)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
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 | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | pilot study and protocol | 31/07/2007 | Yes | No | |
| Results article | results [Development of a complex intervention to test the effectiveness of peer support in type 2 diabetes.] | 31/08/2007 | Yes | No | |
| Results article | results [Peer support for patients with type 2 diabetes: cluster randomised controlled trial] | 15/02/2011 | Yes | No |
Editorial Notes
04/10/2017: internal review.
