Culturally sensitive hypertension counselling for Afro-Surinamese and Ghanaian hypertensive patients in Dutch general practices
| ISRCTN | ISRCTN35675524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35675524 |
| Secondary identifying numbers | 122000008 |
- Submission date
- 17/08/2009
- Registration date
- 27/08/2009
- Last edited
- 10/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joke Haafkens
Scientific
Scientific
Academisch Medicsch Centrum Amsterdam
Department of General Practice
Meibergdreef 15
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7291 |
|---|---|
| j.a.haafkens@amc.uva.nl |
Study information
| Study design | Cluster-randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | OHD2 |
| Study objectives | 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(s) | Medical Ethical Committee of the Academic Medical Centre of the University of Amsterdam approved in May 2009 (ref: IC MEC09/070) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2009 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 148 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academisch Medicsch Centrum Amsterdam
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
The Hague
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| e.j.beune@amc.uva.nl | |
| Website | http://www.zonmw.nl |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 12200008)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/10/2009 | Yes | No | |
| Results article | results | 05/03/2014 | Yes | No |
