Brief Intervention for Type 1 diabetes: Education for Self efficacy

ISRCTN ISRCTN75807800
DOI https://doi.org/10.1186/ISRCTN75807800
Secondary identifying numbers BITES1
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

Study designPragmatic, randomised controlled trial. Secondary care setting.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific title
Study acronymBITES
Study objectivesOur 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) studiedType 1 diabetes
InterventionBrief 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 typeOther
Primary outcome measureThe following were meausred at 3, 6 and 12 months:
1. HbA1c
2. Severe Hypoglycaemia
Secondary outcome measuresThe 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)
Overall study start date01/06/2003
Completion date01/07/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120
Key inclusion criteriaParticipants 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 criteria1. Children under age 18
2. Type 1 for less than 12 months
3. Incapacity to participate fully in the programme
Date of first enrolment01/06/2003
Date of final enrolment01/07/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

York Hospital
York
YO318HE
United Kingdom

Sponsor information

York Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

York Hospital
Wigginton Road
York
YO318HE
England
United Kingdom

Website http://www.yorkhealthservices.org/
ROR logo "ROR" https://ror.org/027e4g787

Funders

Funder type

Government

York NHS Trust Research and Development Innovation Fund. (UK) (Ref 01/08/016)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article Protocol 14/09/2007 Yes No
Results article Results 01/12/2008 Yes No