Contact information
Type
Scientific
Primary contact
Dr Joke Haafkens
ORCID ID
Contact details
Academisch Medicsch Centrum Amsterdam
Department of General Practice
Meibergdreef 15
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7291
j.a.haafkens@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
122000008
Study information
Scientific title
A cluster randomised controlled trial evaluating the effect of an intervention to enhance culturally sensitive hypertension counselling on blood pressure control and adherence to prescribed medication and lifestyle changes among Afro-Surinamese and Ghanaian hypertensive patients in Dutch general practices
Acronym
OHD2
Study hypothesis
The project aims to test, in a cluster randomised trial, the effectiveness of multi-component intervention to improve culturally sensitive hypertension counselling for hypertensive Surinamese and Ghanaian patients who receive care in a Dutch primary care setting and who have an insufficiently controlled blood pressure: systolic blood pressure (SBP) greater than or equal to 140 mmHg and/or diastolic blood pressure (DBP) greater than or equal to 90 mmHg.
Specific hypothesis 1: patients randomised to the intervention (IC) will have, compared with those in usual care condition (UC), a significant reduction in SBP (greater than 10 mmHg) at eight months after the start of the intervention.
Specific hypothesises 2 and 3: patients randomised to the intervention (IC) will show, compared with those in usual care condition (UC), significant differences in compliance with respect to prescribed medication and prescribed lifestyle recommendations at 8 months after the start of the intervention.
Ethics approval
Medical Ethical Committee of the Academic Medical Centre of the University of Amsterdam approved in May 2009 (ref: IC MEC09/070)
Study design
Cluster-randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hypertension
Intervention
Patients in the IC practices will receive hypertension care as recommended by the guidelines from the Dutch College of General Practitioners, but instead of the recommended standard hypertension counselling, IC patients will receive:
1. Three culturally sensitive hypertension counselling sessions conducted by a trained nurse-practitioner
2. Written culturally specific educational materials
3. Referrals to neighbourhood facilities that may support Surinamese and Ghanaian patients in adopting a healthier lifestyle, if needed
4. Prior to each counselling session, an assessment of the blood pressure and self-reported medication and lifestyle adherence, made using standardised measures
The first culturally sensitive counselling session will take place 2 weeks after the baseline assessment interview and the next two sessions 3 and 6 months thereafter.
Patients in UC sites will receive hypertension counselling as usual, based on recommendations of the Dutch Hypertension Guidelines. After finishing the baseline assessment, patients will get appointments for two office visits to receive a new prescription for anti-hypertensive medication. These visits will take place at 3.5 and 6.5 months after the baseline assessment.
At both sites - UC and IC - an attending reserach assistant or nurse practitioner will assess the patients' blood pressure and adherence to medication and lifestyle changes, at baseline and at the 3.5- and 6.5-month office visits using the standardised measurement methods.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Proportion of patients with a significant reduction in the systolic blood pressure (10 mmHg [standard deviation = 15]), at 8 months after inclusion. We have chosen to use baseline SBP minus SBP after 8 months as the primary outcome measure because SBP is the most important factor in determining a patient's cardiovascular risk profile. In almost all cases the DBP will become lower if the SBP becomes lower.
Secondary outcome measures
1. The proportion of patients with adequate adherence to prescribed medication at 8 months after inclusion
2. The proportion of patients with adequate adherence to lifestyle recommendations at 8 months after inclusion
Data will also be collected with respect to factors that characterise the patient group (baseline demographics, baseline medical chart data) and factors that may influence patients' hypertension management (perceptions of hypertension, perceptions of medications, self efficacy, experienced social support in hypertension management, satisfaction with care).
Overall trial start date
01/01/2009
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Primary Care Practitioners:
1. Have to provide hypertension care according to a practice protocol based on the guidelines for cardiovascular risk management from the Dutch Association for General Practitioners
2. Should not participate in any similar study to improve cardiovascular risk management
Patients:
1. Self-identified as Afro-Surinamese or Ghanaian
2. Aged 20 years and older, either sex
3. Diagnosis of hypertension with International Classification of Diseases, tenth edition (ICD-10) codes I10: Essential (primary) hypertension
4. Uncontrolled blood pressure (BP) (greater than or equal to 140/90 mmHg) at the last office visit. In addition all patients must have an uncontrolled BP at the time of the baseline assessment.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
148
Participant exclusion criteria
Patients:
1. No diabetes type 1 or type 2
2. No current participation in other cardiovascular disease-related trials
3. The general practitioner who treats the patients judges him/her unfit for participation (e.g., due to co-morbidity)
4. Unable/unwilling to provide informed consent
Recruitment start date
01/01/2009
Recruitment end date
01/01/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academisch Medicsch Centrum Amsterdam
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van Nieuw Oost Indië 334
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
e.j.beune@amc.uva.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 12200008)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19849857
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24598584
Publication citations
-
Protocol
Haafkens JA, Beune EJ, Moll van Charante EP, Agyemang CO, A cluster-randomized controlled trial evaluating the effect of culturally-appropriate hypertension education among Afro-Surinamese and Ghanaian patients in Dutch general practice: study protocol., BMC Health Serv Res, 2009, 9, 193, doi: 10.1186/1472-6963-9-193.
-
Results
Beune EJ, Moll van Charante EP, Beem L, Mohrs J, Agyemang CO, Ogedegbe G, Haafkens JA, Culturally adapted hypertension education (CAHE) to improve blood pressure control and treatment adherence in patients of African origin with uncontrolled hypertension: cluster-randomized trial., PLoS ONE, 2014, 9, 3, e90103, doi: 10.1371/journal.pone.0090103.