The objective is to investigate whether application of a stepwise work-up strategy in primary care patients with uncontrolled hypertension results in better blood pressure control in a cost-effective manner.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is difference in 24-hour systolic BP between groups at 8
months follow-up.
Secondary outcome
- 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
Background summary
Hypertension is the most important risk factor for the development of
cardiovascular diseases. Despite a wealth of evidence showing that lowering
blood pressure reduces the risk of cardiovascular diseases in a cost-effective
way, complications related to a poor blood pressure control still absorb 10% of
the world's healthcare expenditure. In the Netherlands, where patients with
hypertension are typically managed in primary care, only half of them reach an
office systolic blood pressure target below 140mmHg. Currently, the management
of hypertension is embedded within the cardiovascular risk management (CVRM).
Guidelines on CVRM recommend first of all adequate blood pressure readings.
Lifestyle advising (e.g. reducing intake of salt, licorice, and alcohol,
correct overweight and perform more everyday excercise) should be optimalised,
preferably on a patient-centered basis. Attention should be paid to adherence
to medication. Finally, blood pressure lowering medication should be prescribed
sensibly in those with high blood pressure (i.e. preferably once daily,
considering multiple drugs from different classes at a low dose rather than
less drugs at the highest dose). We expect that a a systematic diagnostic
work-up in this would result in improved blood pressure control.
Study objective
The objective is to investigate whether application of a stepwise work-up
strategy in primary care patients with uncontrolled hypertension results in
better blood pressure control in a cost-effective manner.
Study design
This is a cluster-randomised controlled trial among 40 general practices. The
practices will be randomised to either 'care as usual' or the intervention
group (ratio 1:1) that will receive training in executing 'a protocolised
stepwise work-up'.
Intervention
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 patient needs to achieve a
controlled blood pressure, questionnaires will be filled out by the patient
considering lifestyle, physical activity, salt intake and adherence. After
that, together with the patient, the GP will decide whether improvement of
adherence and adjustment of medication is possible. The patient will be
referred to an internist in case the blood pressure is still uncontrolled at
the end of following this stepwise approach.
Study burden and risks
Participants are asked to fill out 3-4 questionnaires at baseline and after 8
months of follow-up. Also, in both groups 24-hour blood pressure measurement
will be conducted at baseline and after 8 months of follow-up, this is a
frequently used tool for general practitioners to measure the blood pressure,
this will probably not be new for the participants. Patients might consider it
as timeconsuming and as an intrustion into private life. In both groups, blood
samples will be taken after 8 months and at baseline if the patients had lab
testing longer than 3 months ago. This group of patients is used to give blood
samples, we don't expect this to be a heavy burden. Possible complications of
taking a blood sample may be a hematoma or an infection.
Participants in the intervention group will fill out, depending on how many
steps they will need, another 4 questionnaires. They will have a maximum of 7
more consultations with their general practitioner or practice nurse.
Therefore, the burden of time will be bigger than in the controlgroup. A
psychological risk may be that the patient considers himself 'ill' or that
filling out the questionnaires about nutrition or physical activity may be
confrontating. The study population does not involve minors or incapacitated.
The privacy of the participants will be assured.
We think that this is a low-risk study, with high positive impact in the
treatment and consequences of hypertension. Therefore we think the burden and
risks associated with participation will be less important, than the positive
consequences of our study for the treatment of the patient.
Universiteitsweg 100
Utrecht 3584 CG
NL
Universiteitsweg 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
Patients aged > 18 years and < 80 years with an office blood pressure > 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
- A short life expectancy (< 6 months) as judged by the GP.
- Inability to understand or conform to the stepwise protocol.
- Unwillingness to provide a written informed consent.
- In case of suspicion of a hypertensive crisis (systolic blood pressure * 200
mmHg and/or diastolic blood pressure * 120 mmHg) the patient is referred for
further evaluation. If a hypertensive crisis is excluded, the patient can be
included in the study.
- Atrial fibrillation (because of difficulties to interpret 24 hour BP
measurements)
- Pregnancy or breast feeding.
- Severe co-morbidity, which seriously interferes with diagnostic procedures or
possible treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61553.041.17 |