Condition category
Circulatory System
Date applied
17/08/2009
Date assigned
27/08/2009
Last edited
10/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.zonmw.nl

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

  1. 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.

  2. 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.

Additional files

Editorial Notes