Pilot trial to assess the effect of non-medical diabetic kitbag on medication and monitoring adherence amongst adolescent diabetics (15/12/04: STUDY REMOVED FROM NRR AND NHSTCT REGISTER)
| ISRCTN | ISRCTN47792479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47792479 |
| Protocol serial number | N0283124722 |
| Sponsor | Department of Health |
| Funder | Sussex NHS Research Consortium (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Jenny Statham
Scientific
Scientific
Graduate School of Social Sciences
University of Sussex
Brighton
BN1 9QH
United Kingdom
| Phone | +44 (0)1273 723447 |
|---|---|
| jennyfisha1@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Pilot trial to assess the effect of non-medical diabetic kitbag on medication and monitoring adherence amongst adolescent diabetics (15/12/04: STUDY REMOVED FROM NRR AND NHSTCT REGISTER) |
| Study objectives | It is predicted that patients in the kitbag condition will show fewer fluctuations in their daily reporting. |
| Ethics approval(s) | Local medical ethics committee, ref: 15/03 |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | This feasibility study aims to determine whether adherence for both these health behaviours improves between Time 1 and Time 2 in patients issued with a kitbag, compared to patients who are provided with routine medical care. Two questionnaires will be completed by experimental and control subjects at Time 1 and Time 2, which will measure self-reported adherence for both blood glucose monitoring and insulin injection. |
| Intervention type | Other |
| Primary outcome measure(s) |
Differences in blood glucose levels from the norm between the experimental and control conditions, obtained from their diabetic clinic at Time 1 and Time 2. |
| Key secondary outcome measure(s) |
Self-reported changes in: |
| Completion date | 01/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. 40 patients from the Worthing Hospital Paediatric Diabetic Clinic 2. Between 13 and 15 years of age |
| Key exclusion criteria | Adolescent diabetics who have been diagnosed for less than 3 years |
| Date of first enrolment | 09/04/2003 |
| Date of final enrolment | 01/05/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Sussex
Brighton
BN1 9QH
United Kingdom
BN1 9QH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/11/2016: No publications found, verifying study status with principal investigator.
