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The aim of the study is to compare telemedical antihypertensive treatment based on home blood pressure monitoring and conventional antihypertensive treatment based on monitoring of blood pressure in the doctor's office.
We want to test the hypotheses that telemedical treatment is more effective in lowering blood pressure, provide better quality of life and is more cost-effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home blood pressure telemonitoring | Experimental |
| |
| Conventional blood pressure monitoring | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedical blood pressure monitoring | Device | Measurement of home blood pressure, three times per week for three months and once a week for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Number of Patients Who Reached Target Blood Pressure | 6 months | |
| Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months | Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Line B Madsen, MD | Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark | Principal Investigator |
| Erling B Pedersen, Professor | Dept. of Medical Research, Holstebro Hospital, 7500 Holstebro, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Medical Research, Holstebro Hospital | Holstebro | 7500 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21105759 | Derived | Madsen LB, Christiansen T, Kirkegaard P, Pedersen EB. Economic evaluation of home blood pressure telemonitoring: a randomized controlled trial. Blood Press. 2011 Apr;20(2):117-25. doi: 10.3109/08037051.2010.532306. Epub 2010 Nov 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemonitoring | Telemonitoring of home blood pressure |
| FG001 | Conventional | Conventional blood pressure monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Blood Pressure Monitoring | |
| BG001 | Telemonitoring of Home Blood Press | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Number of Patients Who Reached Target Blood Pressure | Not Posted | Number | participants | 6 months | |||||||||||
| Primary | Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months | Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups | Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up. | Posted | Mean | Standard Deviation |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Blood Pressure Monitoring |
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Technical difficulties with telemedical equipment,referral bias,unblinded study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Line Bille Madsen | Dept. of Medical Research, Holstebro Hospital | +45 99125421 | linemads@rm.dk |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| mm Hg |
| baseline and 6 months |
|
|
|
| 0 |
| 123 |
| 0 |
| 123 |
| EG001 | Telemonitoring of Home Blood Press | 0 | 113 | 0 | 113 |
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