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A Comparison of Telemedical and Conventional Antihypertensive Treatment

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ClinicalTrials.gov Identifier: NCT00282334
Recruitment Status : Completed
First Posted : January 26, 2006
Results First Posted : July 29, 2011
Last Update Posted : August 1, 2011
Sponsor:
Information provided by:
Regional Hospital Holstebro

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Device: Telemedical blood pressure monitoring
Enrollment 236
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telemonitoring Conventional
Hide Arm/Group Description Telemonitoring of home blood pressure Conventional blood pressure monitoring
Period Title: Overall Study
Started 113 123
Completed 105 118
Not Completed 8 5
Reason Not Completed
Withdrawal by Subject             8             5
Arm/Group Title Conventional Blood Pressure Monitoring Telemonitoring of Home Blood Press Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 123 113 236
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 113 participants 236 participants
55.0  (11.7) 56.7  (11.6) 55.9  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 113 participants 236 participants
Female
59
  48.0%
58
  51.3%
117
  49.6%
Male
64
  52.0%
55
  48.7%
119
  50.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 123 participants 113 participants 236 participants
123 113 236
1.Primary Outcome
Title Difference in Number of Patients Who Reached Target Blood Pressure
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
2.Primary Outcome
Title Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months
Hide Description Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants determined by power calculations. Analysis based on the principle of intention to treat with LOCF in cases missing at follow up.
Arm/Group Title Conventional Blood Pressure Monitoring Telemonitoring of Home Blood Press
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 123 113
Mean (Standard Deviation)
Unit of Measure: mm Hg
-11.9  (14.8) -9.6  (14.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Blood Pressure Monitoring Telemonitoring of Home Blood Press
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Conventional Blood Pressure Monitoring Telemonitoring of Home Blood Press
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Conventional Blood Pressure Monitoring Telemonitoring of Home Blood Press
Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)   0/113 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conventional Blood Pressure Monitoring Telemonitoring of Home Blood Press
Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)   0/113 (0.00%) 
Technical difficulties with telemedical equipment,referral bias,unblinded study
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Line Bille Madsen
Organization: Dept. of Medical Research, Holstebro Hospital
Phone: +45 99125421
EMail: linemads@rm.dk
Layout table for additonal information
Responsible Party: Erling Bjerregaard Pedersen, Dept. of Medical Research, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT00282334    
Other Study ID Numbers: MED.RES.2004.01.LBM
First Submitted: January 24, 2006
First Posted: January 26, 2006
Results First Submitted: February 18, 2010
Results First Posted: July 29, 2011
Last Update Posted: August 1, 2011