Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
09/12/2008
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 Nigel Sturrock

ORCID ID

Contact details

Consultant Physician
Nottingham City Hospital NHS Trust
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RBG 00XX77

Study information

Scientific title

Acronym

Study hypothesis

To assess the effectiveness of a simple treatment algorithm in primary care in attaining the recommended blood pressure in patients with type 2 diabetes compared to usual practice. To assess the cost-effectiveness of the algorithm for improving blood pressure control in these patients.

Assuming 40% of diabetics have a blood pressure of <140/80 an intracluster correlation coefficient (ICC) of 0.02 and an average cluster size of 45 type 2 diabetics per practice. Based on 80% power and 5% two-sided significance level 388 participants would be required in each arm of the study.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, metabolic and endocrine diseases: Diabetes

Intervention

Not provided at time of registration

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Proportion of participants who have achieved good blood pressure control defined as reaching the recommended level of <140/80.

Secondary outcome measures

Change in blood pressure from baseline, attendance at hypertension review appointments and patient satisfaction with the care received. Both measures will be assessed at 12 months post recruitment to the trial.

Overall trial start date

01/03/2001

Overall trial end date

28/02/2003

Reason abandoned

Eligibility

Participant inclusion criteria

The study population will comprise all patients with type 2 diabetes on the lists of participating general practitioners who give informed consent to participate in the study.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

388 participants would be required in each arm of the study.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2001

Recruitment end date

28/02/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Physician
Nottingham
NG5 1PB
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 Trent (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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17263930

Publication citations

  1. Results

    Bebb C, Kendrick D, Coupland C, Madeley R, Stewart J, Brown K, Burden R, Sturrock N, A cluster randomised controlled trial of the effect of a treatment algorithm for hypertension in patients with type 2 diabetes., Br J Gen Pract, 2007, 57, 535, 136-143.

Additional files

Editorial Notes