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| [ Print-friendly version ] |
| Brief Intervention for Type 1 diabetes: Education for Self efficacy |
| ISRCTN | ISRCTN75807800 |
| ClinicalTrials.gov identifier | |
| Public title | Brief Intervention for Type 1 diabetes: Education for Self efficacy |
| Scientific title | |
| Acronym | BITES |
| Serial number at source | BITES1 |
| Study hypothesis | 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 | Approved by York Research Ethics Commitee. Ref: 01/08/016 |
| Study design | Pragmatic, randomised controlled trial. Secondary care setting. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Type 1 diabetes |
| Participants - 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 |
| Participants - exclusion criteria |
1. Children under age 18
2. Type 1 for less than 12 months 3. Incapacity to participate fully in the programme |
| Anticipated start date | 01/06/2003 |
| Anticipated end date | 01/07/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 120 |
| Interventions |
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. |
| Primary outcome measure(s) |
The following were meausred at 3, 6 and 12 months:
1. HbA1c 2. Severe Hypoglycaemia |
| 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) |
| Sources of funding | York NHS Trust Research and Development Innovation Fund. (UK) (Ref 01/08/016) |
| Trial website | |
| Publications |
1. Protocol on http://www.ncbi.nlm.nih.gov/pubmed/17868462
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/19046244 |
| Contact name | Dr Jonathan Thow |
| Address |
York Hospital
Wigginton Road |
| City/town | York |
| Zip/Postcode | YO318HE |
| Country | United Kingdom |
| Sponsor | York Hospitals NHS Foundation Trust (UK) |
| Address |
York Hospital
Wigginton Road |
| City/town | York |
| Zip/Postcode | YO318HE |
| Country | United Kingdom |
| Sponsor website: | http://www.yorkhealthservices.org/ |
| Date applied | 04/06/2007 |
| Last edited | 13/10/2009 |
| Date ISRCTN assigned | 07/06/2007 |
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