Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/08/2011
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

Dr David Jeavons

ORCID ID

Contact details

Netherlaw
28 Stanhope Road
Darlington
DL3 7SQ
United Kingdom
+44 (0)1325 380640

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRCC701F R340152

Study information

Scientific title

Acronym

Study hypothesis

1. To describe the characteristics of Type 2 diabetic patients with poor glycaemic control on oral therapy and ascertain any factors influencing referral for insulin therapy.
2. To ascertain patient and general practitioner beliefs and attitudes, fears and perceptions towards initiating insulin therapy in diabetic patients poorly controlled on oral treatment.
3. To develop a care package, incorporating these views, for the management of diabetic patients with poor control on oral therapy.
4. To evaluate the effect of a care package for general practice management of diabetic patients with poor control on oral treatment.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, metabolic and endocrine diseases: Diabetes

Intervention

Care package vs standard treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1.1 Characteristics of patients (age, sex, BMI, duration of diabetes, co-morbidity and other clinical features).
1.2 Description of therapy, type and duration.
1.3 Level of diabetic control (HbA1c), duration of oral treatment failure and time to initiation of insulin treatment.
2.1 Ascertainment of factors influencing general practice management and/or hospital referral of diabetic patients with failure of oral treatment.
2.2 Ascertainment of patient and general practitioner attitudes, beliefs, fears and perceptions towards failure of oral treatment and potential insulin therapy.
3. A simple care package for general practice management of the diabetic patient failing on oral treatment.
4.1 Level of glycaemic control before and after the intervention (glycosylated haemoglobin, HbA1c).
4.2 Quality of life assessment before and after the intervention.
4.3 Alteration in use of insulin treatment following introduction of the management package.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/01/1999

Overall trial end date

10/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Type II diabetic patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/01/1999

Recruitment end date

10/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Netherlaw
Darlington
DL3 7SQ
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16679475/

Publication citations

  1. Jeavons D, Hungin AP, Cornford CS, Patients with poorly controlled diabetes in primary care: healthcare clinicians' beliefs and attitudes., Postgrad Med J, 2006, 82, 967, 347-350, doi: 10.1136/pgmj.2005.039545.

Additional files

Editorial Notes