Home Blood Pressure Monitoring and blood pressure (BP) control
| ISRCTN | ISRCTN25105161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25105161 |
| ClinicalTrials.gov number | NCT00202137 |
| Secondary identifying numbers | NA 4882 |
- Submission date
- 14/08/2003
- Registration date
- 08/09/2003
- Last edited
- 18/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marshall Godwin
Scientific
Scientific
Centre for Studies in Primary Care
Dept of Family Medicine
220 Bagot Street
Kingston, Ontario
K7L 5E9
Canada
| Phone | +1 613-549-4480 |
|---|---|
| godwinm@post.queensu.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | HBPM |
| Study objectives | Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of hypertension therapy should be to maximize blood pressure control. Home Blood Pressure Monitoring (HBPM) devices are available and many patients are using them. The role that self-monitoring of blood pressure can play in optimizing blood pressure control is unclear. We hope to clarify the role of home blood pressure monitoring in the treatment of hypertension and explore how it may affect patient and physician behaviours related to blood pressure management. This study will compare a group of hypertensive patients who use HBPM with those who do not use these devices. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | Patients in the intervention group are provided with a home blood pressure monitor that they are to use at least once a week and report the BP measurements to their physician at each follow up visit. |
| Intervention type | Other |
| Primary outcome measure | 1. The mean daytime blood pressures on Ambulatory Blood Pressure Monitoring (ABPM) 2. The mean night-time blood pressures on ABPM 3. Achieving Blood Pressure (BP) target at end of study 4. Achieving 10% drop in the mean nighttime blood pressures |
| Secondary outcome measures | 1. Patient lifestyle changes 2. The number of visits for hypertension 3. Compliance with hypertensive medication use 4. Compliance with the intervention 5. Intensity of treatment 6. Frequency of lifestyle counselling by physician 7. Quality of Life as measured by 36-item Short Form health survey (SF-36) |
| Overall study start date | 01/07/2002 |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 630 |
| 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. A disability that precludes use of a home blood pressure monitor 5. Enrolled in another hypertension trial 6. White coat hypertension |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Centre for Studies in Primary Care
Kingston, Ontario
K7L 5E9
Canada
K7L 5E9
Canada
Sponsor information
Heart and Stroke Foundation of Ontario (Canada)
Charity
Charity
1920 Yonge Street
4th Floor
Toronto, Ontario
M4S 3E2
Canada
| Phone | +1 416 489 7100 |
|---|---|
| mail@hsf.on.ca | |
"ROR" |
https://ror.org/00qbpyp73 |
Funders
Funder type
Charity
Heart and Stroke Foundation of Ontario (Canada)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/12/2003 | Yes | No | |
| Results article | results | 28/06/2005 | Yes | No |
