Brief Intervention for Type 1 diabetes: Education for Self efficacy
ISRCTN | ISRCTN75807800 |
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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
Scientific
York Hospital
Wigginton Road
York
YO318HE
United Kingdom
Study information
Study design | Pragmatic, randomised controlled trial. Secondary care setting. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Other |
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 | The following were meausred at 3, 6 and 12 months: 1. HbA1c 2. Severe Hypoglycaemia |
Secondary outcome measures | 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) |
Overall study start date | 01/06/2003 |
Completion date | 01/07/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
York Hospital
York
YO318HE
United Kingdom
YO318HE
United Kingdom
Sponsor information
York Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
York Hospital
Wigginton Road
York
YO318HE
England
United Kingdom
Website | http://www.yorkhealthservices.org/ |
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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 | |
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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? |
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Protocol article | Protocol | 14/09/2007 | Yes | No | |
Results article | Results | 01/12/2008 | Yes | No |