Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

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