Hypertension
Conditions
Keywords
Telemedicine, Blood pressure, Quality of life, Cost-effectiveness
Brief summary
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.
Interventions
DEVICETelemedical blood pressure monitoring
Measurement of home blood pressure, three times per week for three months and once a week for three months.
Sponsors
Regional Hospital Holstebro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 20 - 80 years * office blood pressure \> 150/95 mmHg or systolic blood pressure \>150 mmHg and diastolic blood pressure \< 90 mmHg
Exclusion criteria
* not able to perform home blood pressure measurements * low compliance * abuse of alcohol/ medicine * unwillingness to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline and 6 months | Comparison of mean change in daytime systolic ambulatory blood pressure from baseline to follow up after 6 months between the two groups |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Blood Pressure Monitoring | 123 |
| Telemonitoring of Home Blood Press | 113 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | Conventional Blood Pressure Monitoring | Telemonitoring of Home Blood Press | Total |
|---|---|---|---|
| Age Continuous | 55.0 years STANDARD_DEVIATION 11.7 | 56.7 years STANDARD_DEVIATION 11.6 | 55.9 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment Denmark | 123 participants | 113 participants | 236 participants |
| Sex: Female, Male Female | 59 Participants | 58 Participants | 117 Participants |
| Sex: Female, Male Male | 64 Participants | 55 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 123 | 0 / 113 |
| serious Total, serious adverse events | 0 / 123 | 0 / 113 |
Outcome results
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
Time frame: baseline and 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Blood Pressure Monitoring | Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months | -11.9 mm Hg | Standard Deviation 14.8 |
| Telemonitoring of Home Blood Press | Difference in Mean Daytime Systolic Ambulatory Blood Pressure From Baseline to Follow-up After Six Months | -9.6 mm Hg | Standard Deviation 14.7 |
Primary
Difference in Number of Patients Who Reached Target Blood Pressure
Time frame: 6 months