Conventional Versus Automated Measurement of Blood Pressure in the Office
| ISRCTN | ISRCTN12912185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12912185 |
| ClinicalTrials.gov number | NCT00325832 |
| Secondary identifying numbers | 392-2005 |
- Submission date
- 11/05/2006
- Registration date
- 19/06/2006
- Last edited
- 08/01/2021
- 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 Martin Myers
Scientific
Scientific
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
| martin.myers@sunnybrook.ca |
Study information
| Study design | A cluster randomized, controlled, clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| Scientific title | Conventional Versus Automated Measurement of Blood Pressure in the Office |
| Study acronym | The CAMBO Study |
| Study objectives | Automated office systolic blood pressure (SBP) recordings in routine clinical practice using the BpTRU device will reflect more accurately the mean awake ambulatory systolic blood pressure (BP) than manual BP readings taken with conventional mercury sphygmomanometry. This should lead to improvements in the management of systolic hypertension with optimization of drug therapy in practices using the BpTRU device. |
| Ethics approval(s) | Approved by the Sunnybrook Research Ethics Board (REB) on 20/10/2005, reference number: 392-2005 |
| Health condition(s) or problem(s) studied | Systolic hypertension |
| Intervention | Measurement of blood pressure using automated office BP with a target of 135 mmHg versus office mercury sphygmomanometer with a target of 140 mmHg |
| Intervention type | Other |
| Primary outcome measure | Differences in SBP between the mean awake ambulatory BP and the manual office BP versus the difference in SBP between the mean awake ambulatory BP and the automated office BP |
| Secondary outcome measures | 1. Differences in SBP between the mean awake 24-hour ambulatory BP and the manual office BP versus the automated BP 2. Differences in SBP between the mean nocturnal ambulatory BP and the manual office BP versus the automated BP 3. Differences in coefficients of correlation (r value) between the awake ambulatory BP and the manual versus automated office BP 4. Differences in the coefficients of correlation between the manual office SBP versus the automated BP versus the mean awake, 24-hour or nocturnal ambulatory SBP 5. Differences in the primary outcome between men and women 6. Adverse effects related to management of hypertension with manual versus automated BP 7. Differences in intensity of drug therapy for manual versus automated office BP patients 8. Frequency of medication changes for manual versus automated office BP patients 9. Cost of drug therapy at year two for manual versus automated office BP patients 10. Clinical events of serious adverse events reported for manual versus automated office BP patients |
| Overall study start date | 15/01/2006 |
| Completion date | 15/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 461 |
| Key inclusion criteria | Both treated and untreated patients with systolic hypertension under routine family physician (FP) care. For untreated patients, routine office SBP as measured by the patient's FP at the last routine office visit using a mercury device must have SBP ≥160 mmHg and diastolic blood pressure (DBP) ≤95 mmHg. For patients already receiving antihypertensive therapy, the last routine office BP as measured by the patient's FP using mercury sphygmomanometry must be SBP ≥140 mmHg and DBP ≤90 mmHg. |
| Key exclusion criteria | 1. Presence of target organ damage such as myocardial infarction (MI), stroke, and serum creatinine twice the upper limit of normal 2.Diabetes mellitus treated with insulin or oral hypoglycemic therapy 3. Secondary hypertension 4. Participation in another research study involving measurement of BP 5. Patient's insistence on using self BP measurement outside of the study 6. Any conditions or circumstances which might preclude the successful completion of the study |
| Date of first enrolment | 15/01/2006 |
| Date of final enrolment | 15/01/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
2075 Bayview Avenue
Toronto
M4N 3M5
Canada
M4N 3M5
Canada
Sponsor information
Heart and Stroke Foundation of Ontario (Canada)
Charity
Charity
1920 Yonge Street
Fourth Floor
Toronto
M4S 3E2
Canada
| efreeman@hsf.on.ca | |
"ROR" |
https://ror.org/00qbpyp73 |
Funders
Funder type
Charity
Heart and Stroke Foundation of Ontario
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? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | 08/01/2021 | Yes | No |
Editorial Notes
08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT number has been added.
