Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
22/08/2016
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

Dr Kirsty Winkley

ORCID ID

Contact details

Department of Psychological Medicine
Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4299

Study information

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

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

South East Ethics Committee 3 approved on the 30th November 2009 (ref: 09/H0808/97)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Phase II

Drug names

Primary outcome measures

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 trial start date

04/04/2008

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 432

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

04/04/2008

Recruitment end date

01/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
London
SE5 9RJ
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Foundation Trust (UK)

Sponsor details

Department of Research & Development
34 Love Walk
London
SE5 8AD
United Kingdom

Sponsor type

Government

Website

http://www.kch.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research (ref: RP-PG-0606-1142)

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

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27006306

Publication citations

Additional files

Editorial Notes

22/08/2016: Publication reference added