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
Secondary identifying numbers	N0283124722

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

Graduate School of Social Sciences
University of Sussex
Brighton
BN1 9QH
United Kingdom

Phone	+44 (0)1273 723447
Email	jennyfisha1@hotmail.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a 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	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.
Secondary outcome measures	Self-reported changes in: 1. Self-efficacy 2. Attitudes towards diabetes 3. Attitudes towards adherence 4. Self-esteem 5. Social norms Between Time 1 and Time 2.
Overall study start date	09/04/2003
Completion date	01/05/2003

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	13 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

University of Sussex

Brighton
BN1 9QH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Sussex NHS Research Consortium (UK)

No information available

Results and Publications

Intention to publish date
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

Editorial Notes

02/11/2016: No publications found, verifying study status with principal investigator.