STEPWISE treatment of uncontrolled HyperTensioN in primary care: a cluster randomised trial.

STEPWISE treatment of uncontrolled HyperTensioN in primary care: a cluster randomised trial. - STEPWISE HTN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50648

Enrollment

240

Registered

2017-11-08

Start date

2018-10-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high bloodpressure not responding to medication therapieresistant hypertension

Interventions

Trained GP's will execute a protocol involving a stepwise approach. The first step will be 24-hour blood pressure messurement to exclude white coat hypertension. Depending on how many steps a patien

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged > 18 years and 140/90 mmHg, on at least two blood pressure measurements per visit and on at least two occasions in the last year despite prescription of three or more blood pressure lowering drugs of different classes at adequate dosage, with for each antihypertensive drug at least 1 prescription of 3 months. During the inclusion consultation, the office blood pressure should be > 140/90 mmHg (measured according to the guideline on *standardized office blood pressure measurement based on the NHG CVRM guideline).

Exclusion criteria

Exclusion criteria: - A short life expectancy (

Design outcomes

Primary

Measure	Time frame
The primary outcome is difference in 24-hour systolic BP between groups at 8 months follow-up.	—

Secondary

Measure	Time frame
- The percentage of patients with an office BP * 140/90 or a mean 24-hour BP 130/80 mmHg, measured at the endpoint (8 months). - The time window (time from baseline) to reach a controlled BP during the study, defined as twice an office BP of 140/90 mmHg, or a mean 24-hours BP of *130/80 mmHg. - The number and/or dosage needed of BP lowering drugs, measured during the study time. - Referral to the medical specialist during the study time. - Health care use and associated costs during the study period or bp control/bp related events. - Quality of life as measured with the EQ5D and EQ-VAS at baseline and at the endpoint (8 months). - Cost-effectiveness of the intervention expressed in terms of cost per patient reaching adequate BP level and cost per Quality Adjusted Life Year Gained. - Self-reported BMI	—

Measure

Time frame

- The percentage of patients with an office BP * 140/90 or a mean 24-hour BP *130/80 mmHg, measured at the endpoint (8 months). - The time window (time from baseline) to reach a controlled BP during the study, defined as twice an office BP of *140/90 mmHg, or a mean 24-hours BP of *130/80 mmHg. - The number and/or dosage needed of BP lowering drugs, measured during the study time. - Referral to the medical specialist during the study time. - Health care use and associated costs during the study period or bp control/bp related events. - Quality of life as measured with the EQ5D and EQ-VAS at baseline and at the endpoint (8 months). - Cost-effectiveness of the intervention expressed in terms of cost per patient reaching adequate BP level and cost per Quality Adjusted Life Year Gained. - Self-reported BMI

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)