Condition category
Circulatory System
Date applied
14/08/2003
Date assigned
08/09/2003
Last edited
19/10/2007
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 Marshall Godwin

ORCID ID

Contact details

Centre for Studies in Primary Care
220 Bagot Street
Kingston
Ontario
K7L 5E9
Canada
+1 613-549-4480
godwinm@post.queensu.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA 4884

Study information

Scientific title

Acronym

ISM

Study hypothesis

Comparing intensive scheduled management of hypertension (aggressive achievement of target blood pressure over 16 weeks) with usual management of hypertension.

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

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Blood pressure control on 24-hour Ambulatory Blood Pressure Monitoring (ABPM), measured at 16 weeks and one year.

Secondary outcome measures

1. Patient quality of life
2. Physician compliance with the intensive protocol
3. Patient compliance with medication
4. Adverse effects

Overall trial start date

01/07/2002

Overall trial end date

01/11/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. A diagnosis of secondary hypertension
2. Pregnancy
3. Hypertension management primarily by a consultant
4. Inability to provide informed consent

Recruitment start date

01/07/2002

Recruitment end date

01/11/2006

Locations

Countries of recruitment

Canada

Trial participating centre

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

Sponsor information

Organisation

The Heart and Stroke Foundation of Ontario (Canada)

Sponsor details

1920 Yonge Street
4th Floor
Toronto
Ontario
M4S 3E2
Canada
+1 416 489 7100
mail@hsf.on.ca

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

The Heart and Stroke Foundation of Ontario (Canada)

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

Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&dopt=AbstractPlus&list_uids=14690550

Publication citations

  1. Protocol

    Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R, Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity., BMC Med Res Methodol, 2003, 3, 28, doi: 10.1186/1471-2288-3-28.

Additional files

Editorial Notes