Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study)
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Key result
Home blood pressure telemonitoring will be evaluated against conventional management in a randomized controlled trial to determine its effect on daytime ambulatory blood pressure normalization over 48 weeks in patients with hypertension and metabolic syndrome.
Why the study?
Does home blood pressure telemonitoring improve daytime ambulatory blood pressure control in hypertensive patients with metabolic syndrome?
Population
252 planned adult patients with treated or untreated but uncontrolled essential arterial hypertension and…
Comparison
Home blood pressure telemonitoring with… vs Conventional management with blood pressure…
Design
Other, Blocked randomization procedure, 1:2 ratio, Open label
Follow-up
48 weeks
Authors
Discussion
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Implication
This study protocol describes a randomized trial to determine if home blood pressure telemonitoring improves blood pressure control and adherence in hypertensive patients with metabolic syndrome compared to conventional office-based management.
Study Design
Type
RCT (n=252)
Blinding
Open-label
Randomization
Blocked randomization (1:2 ratio)
Multicenter
Yes
Structured PICO
Does home blood pressure telemonitoring improve daytime ambulatory blood pressure control in hypertensive patients with metabolic syndrome?
P
Population
A planned randomized controlled trial of 252 adults aged 18-74 with uncontrolled essential hypertension and metabolic syndrome, followed for 48 weeks.
I
Intervention
Home blood pressure telemonitoring (HBPT) with automated teletransmission of home BP values to the investigator monthly for 24 weeks, followed by manual transmission before quarterly office visits for the next 24 weeks.
C
Comparator
Conventional management (CM) with blood pressure measured exclusively during quarterly office visits.
O
Outcome
Rate of subjects achieving normal daytime ambulatory blood pressure targets (< 135/85 mmHg) 24 weeks and 48 weeks after randomization.surrogate
This study protocol describes a randomized trial to determine if home blood pressure telemonitoring improves blood pressure control and adherence in hypertensive patients with metabolic syndrome compared to conventional office-based management.
Limitations
- Allocation concealment using sequentially numbered, opaque, and sealed envelopes rather than central computerized randomization may introduce bias.
- Assessment of medication adherence based on self-report and manual pill count rather than electronic pill-box monitoring might be imprecise.
Cite This Study
Parati et al. (2013) conducted an RCT in Essential arterial hypertension and metabolic syndrome (n=252). Home blood pressure telemonitoring (HBPT) vs. Conventional management (CM) was evaluated on Rate of subjects achieving normal daytime ambulatory blood pressure targets (<135/85 mmHg) 24 weeks and 48 weeks after randomization. Home blood pressure telemonitoring will be evaluated against conventional management in a randomized controlled trial to determine its effect on daytime ambulatory blood pressure normalization over 48 weeks in patients with hypertension and metabolic syndrome.
Topics
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