Ambulant versus unattended & attended office versus self-home blood pressure measurement

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. Age of 18 years or older
2. Documented medical history of hypertension in local hospital electronic
patient record
3. Stable dose of anti-hypertensive medication for at least 2 months (includes
no current antihypertensive medication, diagnosis hypertension is enough)
4. SBP>90 and <180 mmHg and DBP >60 and <110mmHg at inclusion screening
attained by attended AOBP
5. Dutch and/or English language capable for reading patient information letter
and in-app instructions.
6. Smartphone or tablet owner with either iOS or Android installed as operating
system. Operating system requirements: iOS 8.0 or higher, Android version 4.1
or higher.

Exclusion Criteria

1. SBP >180 mmHg and/or DBP >110mmHg at inclusion screening visit (attended
AOBP).
2. Any BP that according to the treating physician is not adequately controlled
and needs medication adjustment < 2 months or within the study time period.
3. Recent (<2 months) anti-hypertensive medication changes (including
diuretics).
4. Recent start or change in dosing of alpha-blockers prescribed for other
purpose than blood pressure control (for example benign prostate hypertrophy).
5. Unstable or uncontrolled endocrine disease (e.g. thyroid disease, Cushing*s
or Addison*s disease) with the exception of diabetes mellitus.
6. Persistend arrhythmias that prevent any BP measurement device to correctly
measure BP during inclusion screening visit; such as supraventricular
arrhythmias or atrial ventricular block. Known arrhythmias, but not clinically
present during inclusion screening is not an exclusion criterion.
7. Heart failure grade 2 or higher on the New York Heart Association (NYHA)
Functional Classification.
8. Documented missed outpatient clinic appointments (2 or more the last 6
months).
9. Documented therapy non-adherence (e.g. biochemical proven medication
non-adherence, known or highly suspected medication non-adherence by treating
physician, proven direct observed therapy effect in BP).
10. Participants cannot plan a measurement schedule with a minimum of 21 and a
maximum of 29-day period participation or a minimum of 4 and maximum of 5
hospital visits due to logistical issues or scheduling issues of any kind.
11. Physical inability to perform an home BP measurement, use the Microlife A6
BT BP device and or Microlife@Home app.
12. For Women: active pregnancy or planning trying to get pregnant during the
study period.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The main study parameters are twofold:<br /><br>(1) Mean difference between HBPM and ABPM values calculated with the<br /><br>Bland-Altman method<br /><br>(2) Mean standard deviation (SD) of the mean difference between HBPM and ABPM<br /><br>calculated with the Bland-Altman method.<br /><br>- Both expressed in mmHg for both SB and DBP (see primary objective chapter 2).<br /><br>- The HBPM value is a 7-day average of systolic and diastolic BP<br /><br>- The ABPM value is an average BP measured by 24-hour ambulatory measurements </p><br>

Secondary Outcome Measures