Contact information
Type
Scientific
Primary contact
Ms Jenny Statham
ORCID ID
Contact details
Graduate School of Social Sciences
University of Sussex
Brighton
BN1 9QH
United Kingdom
+44 (0)1273 723447
jennyfisha1@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0283124722
Study information
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)
Acronym
Study hypothesis
It is predicted that patients in the kitbag condition will show fewer fluctuations in their daily reporting.
Ethics approval
Local medical ethics committee, ref: 15/03
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
09/04/2003
Overall trial end date
01/05/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. 40 patients from the Worthing Hospital Paediatric Diabetic Clinic
2. Between 13 and 15 years of age
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant exclusion criteria
Adolescent diabetics who have been diagnosed for less than 3 years
Recruitment start date
09/04/2003
Recruitment end date
01/05/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sussex
Brighton
BN1 9QH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sussex NHS Research Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary