Brief Intervention for Type 1 diabetes: Education for Self efficacy

ISRCTN	ISRCTN75807800
DOI	https://doi.org/10.1186/ISRCTN75807800
Protocol serial number	BITES1
Sponsor	York Hospitals NHS Foundation Trust (UK)
Funder	York NHS Trust Research and Development Innovation Fund. (UK) (Ref 01/08/016)

Submission date: 04/06/2007
Registration date: 07/06/2007
Last edited: 13/10/2009

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 Jonathan Thow
Scientific

York Hospital
Wigginton Road
York
YO318HE
United Kingdom

Study information

Primary study design	Interventional
Study design	Pragmatic, randomised controlled trial. Secondary care setting.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BITES
Study objectives	Our hypothesis was that the effectiveness of a brief (2.5-day) psycho-educational intervention for self-management in people with type 1 diabetes in a realistic clinical out-patient setting would be comparable to that of established longer interventions.
Ethics approval(s)	Approved by York Research Ethics Commitee. Ref: 01/08/016
Health condition(s) or problem(s) studied	Type 1 diabetes
Intervention	Brief Intervention in Type 1 Diabetes: Education for Self-Efficacy Course (BITES), developed by a multi-disciplinary team including Consultant Diabetologist, Diabetes Specialist Nurse, Specialist Diabetes Dietician and Clinical Health Psychologist, and delivered as a 2.5-day course over a 6-week period to allow participants time to practice and reflect between sessions. The sessions were facilitated by a Diabetes Specialist Nurse and Specialist Diabetes Dietician. The goal of BITES is to motivate and enable the patients to strive for blood glucose values as normal as possible. All those agreeing to participate will be asked to convert to a basal bolus insulin regime based on two injections of isophane insulin (morning and evening) and meal-related rapid acting insulin. Insulin dose adjustment skills will be based on the Dusseldorf and DAFNE (Dose Adjustment For Normal Eating) principles of treatment to target glucose and insulin matching to carbohydrate portions. The nutritional emphasis will be on normal eating and unrestricted patient choice. The control group recieved standard care.
Intervention type	Other
Primary outcome measure(s)	The following were meausred at 3, 6 and 12 months: 1. HbA1c 2. Severe Hypoglycaemia
Key secondary outcome measure(s)	The following were meausred at 3, 6 and 12 months: 1. Blood pressure 2. Weight 3. Height 4. Total cholesterol 5. Triglycerides 6. Psychological questionnaire with the following scales: 6.1. Short Form 36 6.2. Illness Perception Questionnaire (IPQ) 6.3. Diabetes Knowledge Test (DKT) 6.4. Diabetes Empowerment Scale (DES) 6.5. Diabetes Treatment Satisfaction Questionnaire (DTS-Q) 6.6. Hypoglycaemia Fear Scale (HFS) 6.7. Diabetes Health Profile (DHP) 6.8. Diabetes Self-Managing Adherence questionnaire (DSMA-Q)
Completion date	01/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	Participants were recruited from the Diabetes Centre of York Health Services NHS Trust. Eligibility criteria were: 1. Type 1 diabetes for longer than 12 months 2. Multiple injection therapy for at least two months 3. Minimum age 18 4. Able and willing to participate in the intervention
Key exclusion criteria	1. Children under age 18 2. Type 1 for less than 12 months 3. Incapacity to participate fully in the programme
Date of first enrolment	01/06/2003
Date of final enrolment	01/07/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

York Hospital

York
YO318HE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/12/2008		Yes	No
Protocol article	Protocol	14/09/2007		Yes	No