Diabetes 6 (D-6) trial: psychologically enhanced diabetes care, delivered by nurses
| ISRCTN | ISRCTN75776892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75776892 |
| Secondary identifying numbers | 4299 |
- Submission date
- 19/05/2010
- Registration date
- 19/05/2010
- Last edited
- 14/06/2017
- 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
Not provided at time of registration
Contact information
Dr Kirsty Winkley
Scientific
Scientific
Department of Psychological Medicine
Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of 'Psychologically Enhanced Diabetes Care, delivered by nurses' (D-6) for people with Type 2 diabetes and sub-optimal glycaemic control |
| Study acronym | D-6 |
| Study hypothesis | Some people with type 2 diabetes (T2DM) have problems reaching ideal blood glucose levels that will prevent a worsening of their condition. They may need to make significant lifestyle changes to do this which can be very difficult. Often it may be a question of being unsure whether they can make the changes not that they don't know what changes to make. Talking therapies such as motivational interviewing and cognitive behavioural therapy can help people talk through their difficulties within a supportive relationship and help foster their own self confidence in their ability to make changes. These therapies have increasingly been used in health settings although usually delivered by psychologists but the skills involved can be taught to non-psychologists such as practice nurses. The aim of this study is to train practice nurses (for intervention GP practices) in talking therapy for diabetes and compare their patients with those from practices where nurses have not had the training. We would invite approximately 24 GP practices from the London boroughs of Lambeth, Southwark and Lewisham to participate and these would be randomised and nurses in the intervention practices would receive training. Nurses working in the non-intervention (control) GP practices would receive additional training in diabetes education. If this study shows that training nurses in talking therapy helps their patients to get better control of their diabetes this training could be offered to other practice nurses working in the NHS. |
| Ethics approval(s) | 1. South East Ethics Committee 3, 30/11/2009, ref: 09/H0808/97 2. Research & Development Centre for South East London NHS, 05/05/2010, ref: RDLSL 534/CSP 20423 |
| Condition | Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Hypertension, Dyslipidaemia, Diabetic Control, Obesity, Prevention/screening |
| Intervention | Baseline blood tests are taken in both the treatment and control groups. Patients are randomised to: 1. D-6 treatment group: face to face psychological diabetes care sessions. Maintenance psychological diabetes sessions, specified by patient, may be telephone/e-mail/face to face. 2. Control group: Face to face diabetes education sessions. Maintenance education sessions specified by patient, may be telephone/e-mail/face to face. Follow-up blood tests are then taken in both the treatment and control groups. Total duration of intervention: 12 months Total duration of follow-up: 6 months |
| Intervention type | Other |
| Primary outcome measure | Change in HbA1c (glycaemic control) at 18 months |
| Secondary outcome measures | 1. Total cholesterol, taken at baseline and at end of study 2. Blood pressure, taken at baseline and at end of study 3. BMI, taken at baseline and at end of study 4. Quality of life, measured before and after intervention 5. Depressive symptoms, measured before and after intervention 6. Economic evaluation, measured before and after intervention |
| Overall study start date | 15/10/2007 |
| Overall study end date | 30/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 432 |
| Participant inclusion criteria | 1. People with Type 2 diabetes for more than 2 years 2. Resident in south London boroughs of Lambeth Southwark and Lewisham 3. Aged 18 - 79 years, either sex 4. Persistent suboptimal glycaemic control defined as HbA1c above or equal to 8% on occasions in the past 12 months despite 2 appointments with a diabetes health professional |
| Participant exclusion criteria | 1. Severe mental disorders 2. Terminal illnesses and severe end stage diabetes complications 3. Morbid obesity with a body mass index (BMI) greater than 50 kg/m^2 as there is usually comorbid psychiatric morbidity 4. No telephone or mobile phone access as telephone contact is part of the intervention |
| Recruitment start date | 27/09/2010 |
| Recruitment end date | 11/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Psychological Medicine
London
SE5 9RJ
United Kingdom
SE5 9RJ
United Kingdom
Sponsor information
King's College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Research & Development
34 Love Walk
London
SE5 8AD
England
United Kingdom
| Website | http://www.kch.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01n0k5m85 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research (ref: RP-PG-0606-1142)
No information available
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? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2016 | Yes | No |
Editorial Notes
14/06/2017: The overall trial dates have been updated from 04/04/2008 - 01/04/2010 to 15/10/2007 - 30/11/2016 and the recruitment dates have been updated from 04/04/2008 - 01/04/2010 to 27/09/2010 - 11/10/2011.
22/08/2016: Publication reference added
