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
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
-
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.