Blood pressure control in diabetes in primary care

ISRCTN	ISRCTN12187583
DOI	https://doi.org/10.1186/ISRCTN12187583
Secondary identifying numbers	RBG 00XX77

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Nigel Sturrock
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, metabolic and endocrine diseases: Diabetes
Intervention	Not provided at time of registration
Intervention type	Other
Primary outcome measure	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 study start date	01/03/2001
Completion date	28/02/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	388 participants would be required in each arm of the study.
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/2001
Date of final enrolment	28/02/2003

Consultant Physician

Nottingham
NG5 1PB
United Kingdom

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive Trent (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2007		Yes	No