Intensive Scheduled Management strategy for improving blood pressure control in patients in primary care

ISRCTN	ISRCTN05874865
DOI	https://doi.org/10.1186/ISRCTN05874865
Protocol serial number	NA 4884
Sponsor	The Heart and Stroke Foundation of Ontario (Canada)
Funder	The Heart and Stroke Foundation of Ontario (Canada)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Marshall Godwin
Scientific

Centre for Studies in Primary Care
220 Bagot Street
Kingston, Ontario
K7L 5E9
Canada

Phone	+1 613-549-4480
Email	godwinm@post.queensu.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ISM
Study objectives	Comparing intensive scheduled management of hypertension (aggressive achievement of target blood pressure over 16 weeks) with usual management of hypertension.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Hypertension
Intervention	This study is designed to test the premise that guidelines, to be effective in primary care, need to be operationalised for the practitioner. To this end we have devised a protocol where medications are initiated at the recommended starting dose and increased by one recommended increment before adding the next drug. The goal is to increase the medications over the 16-week period such that, if necessary to reach the target blood pressure level, a patient is on a medium dose of three different antihypertensive agents.
Intervention type	Other
Primary outcome measure(s)	Blood pressure control on 24-hour Ambulatory Blood Pressure Monitoring (ABPM), measured at 16 weeks and one year.
Key secondary outcome measure(s)	1. Patient quality of life 2. Physician compliance with the intensive protocol 3. Patient compliance with medication 4. Adverse effects
Completion date	01/11/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	1. Adults (age 18 and older) who are patients of family physicians 2. Must be diagnosed with essential hypertension but not have yet achieved target levels
Key exclusion criteria	1. A diagnosis of secondary hypertension 2. Pregnancy 3. Hypertension management primarily by a consultant 4. Inability to provide informed consent
Date of first enrolment	01/07/2002
Date of final enrolment	01/11/2006

Centre for Studies in Primary Care

Kingston, Ontario
K7L 5E9
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	22/12/2003		Yes	No