The overall aim of the study is to evaluate the effect of CVPE in Afro-Surinamese and Ghanaian who are treated for HTN in general practice and who have an uncontrolled blood pressure. (systolic BP > 140 mmHG and/or diastolic BP > 90 mmHG)Theā¦
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline systolic BP minus systolic BP after 8 months (BP will be measured
according to protocol: Average of two electronic BP measurements which are
conducted with an interval of 15 minutes in sitting patients)
Secondary outcome
Changes after eight months with regard to the degree of medication compliance,
compliance with life style recommendations, potentially mediating factors for
hypertension management (beliefs, motivation, self efficacy) and satisfaction
with care. These parameters will be measured through questionnaires
Background summary
In Western countries, hypertension (HTN) is more prevalent among
ethnic-minority populations of African descent, and the HTN-related health
outcomes of these groups are worse than those of Europeans. In the Netherlands
high rates of HTN have been observed among two major immigrant groups of
African descent: African-Surinamese from the former Dutch colony of Suriname
(hereafter, Surinamese) and Ghanaians. Hypertension is a major risk factor for
cardiovascular morbidity and mortality. This risk can be prevented through
anti-hypertensive medication and lifestyle modification. However, compliance
with these measures is often low, particularly within ethnic minority
populations. Tailored forms of patient education and counselling can support
patients with the implementation of medication and lifestyle changes and
improve compliance. Based on in formation from a previous project (Heebroedoe)
the research group has developed a protocol for culturally sensitive patient
education (CSPE) for hypertensive patients for general practices. The protocol
was particularly focussed on patients from Ghanaian and Afro-Surinamese
descent. A follow up project demonstrated that the protocol is applicable in
practice, particularly by trained nurse practitioners (NP).
Study objective
The overall aim of the study is to evaluate the effect of CVPE in
Afro-Surinamese and Ghanaian who are treated for HTN in general practice and
who have an uncontrolled blood pressure. (systolic BP > 140 mmHG and/or
diastolic BP > 90 mmHG)
The primary specific aim is;
To establish if patients who have received CVPE (intervention group) have a
significant reduction in their systolic BP (> = 10 mmHG) as compared to a
control group, at eight months after the start of the intervention.
Secondary specific aims are:
To evaluate if patients who have received CVPE (intervention group) show
significant differences in compliance with respect to medication use as
compared to a control group, at eight months after the start of the
intervention.
To evaluate if patients who have received CVPE (intervention group) show
significant differences in compliance with respect to life style
recommendations as compared to a control group, at eight months after the start
of the intervention.
Study design
Randomized controled trial, in which data will be collected at the level of the
patients and radomization will take place at the level of health care centers
(clusters). In addition to this a proces evaluation will be conducted to gain
insight in contextual factors that may influence the effect of the
intervention.
Intervention
Patients in the intervention group will receive three educational counselling
sessions according to the protocol of culturally sensitive hypertension
education with an interval of three months. Patients in the control group will
receive care as usual.
Study burden and risks
1.
At baseline (T0) a research nurse will patients BP, weight length and
waistline) and a research assistent will conduct an interview with them.
2.
Patients in the control group will receive care as ususal. Patients in the
intervention group will receive three counselling consults with an interval of
three months from a nurse practitioner.
3. At three moments in patients of the intervention group and at two moments in
patients of the control group the BP will be measures and they will be asked to
fill out a short questionnaire regarding medication use and life style changes
(with an interval of three months).
4. At 8 months, base line measurements that were performed at (T0) will be
repeated: a research nurse will measure patients BP, weight length and
waistline and a research assistent will conduct an interview with them.
5. After 8 months, some patients (< =15) will be asked to provide a more
extensive interview regarding their experiences for the process analysis.
Meibergdreef 15
1105 AZ Amsterdam
NL
Meibergdreef 15
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
African-Surinamese of Ghanaian (self-identification)
Aged 20 or more
Diagnosis hypertension
Uncontrolled blood pressure (>140/90)
Exclusion criteria
Diabetes Mellitus type I+II
Participation in other trials for cardiovascular disease
If GP decides a patient is not appropriate for participation (e.g. co-morbidity)
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 | NL27507.018.09 |