Trial Outcomes & Findings for A Comparison of Telemedical and Conventional Antihypertensive Treatment (NCT NCT00282334)
NCT ID: NCT00282334
Last Updated: 2011-08-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
236 participants
Primary outcome timeframe
6 months
Results posted on
2011-08-01
Participant Flow
Participant milestones
| Measure |
Telemonitoring
Telemonitoring of home blood pressure
|
Conventional
Conventional blood pressure monitoring
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
123
|
|
Overall Study
COMPLETED
|
105
|
118
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Telemonitoring
Telemonitoring of home blood pressure
|
Conventional
Conventional blood pressure monitoring
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
Baseline Characteristics
A Comparison of Telemedical and Conventional Antihypertensive Treatment
Baseline characteristics by cohort
| Measure |
Conventional Blood Pressure Monitoring
n=123 Participants
|
Telemonitoring of Home Blood Press
n=113 Participants
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
55.0 years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
56.7 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
55.9 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
119 Participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
123 participants
n=93 Participants
|
113 participants
n=4 Participants
|
236 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.
Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups
Outcome measures
| Measure |
Conventional Blood Pressure Monitoring
n=123 Participants
|
Telemonitoring of Home Blood Press
n=113 Participants
|
|---|---|---|
|
Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months
|
-11.9 mm Hg
Standard Deviation 14.8 • Interval -6.1 to 1.5
|
-9.6 mm Hg
Standard Deviation 14.7 • Interval -6.1 to 1.5
|
Adverse Events
Conventional Blood Pressure Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Telemonitoring of Home Blood Press
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Line Bille Madsen
Dept. of Medical Research, Holstebro Hospital
Phone: +45 99125421
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place