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
BACKGROUND
Individuals of African descent living in western countries have increased rates of hypertension and hypertension-related complications. Poor adherence to hypertension treatment (medication and lifestyle changes) has been identified as one of the most important modifiable causes for the observed disparities in hypertension related complications, with patient education being recommended to improve adherence. Despite evidence that culturally-appropriate patient education may improve the overall quality of care for ethnic minority patients, few studies have focused on how hypertensive individuals of African descent respond to this approach. This paper describes the design of a study that compares the effectiveness of culturally-appropriate hypertension education with that of the standard approach among Surinamese and Ghanaian hypertensive patients with an elevated blood pressure in Dutch primary care practices.


METHODS/DESIGN
A cluster-randomized controlled trial will be conducted in four primary care practices in Amsterdam, all offering hypertension care according to Dutch clinical guidelines. After randomization, patients in the usual care sites (n = 2) will receive standard hypertension education. Patients in the intervention sites (n = 2) will receive three culturally-appropriate hypertension education sessions, culturally-specific educational materials and targeted lifestyle support. The primary outcome will be the proportion of patients with a reduction in systolic blood pressure >or= 10 mmHg at eight months after the start of the trial. The secondary outcomes will be the proportion of patients with self-reported adherence to (i) medication and (ii) lifestyle recommendations at eight months after the start of the trial. The study will enrol 148 patients (74 per condition, 37 per site). Eligibility criteria for patients of either sex will be: current diagnosis of hypertension, self-identified Afro-Surinamese or Ghanaian, >or= 20 years, and baseline blood pressure >or= 140/90 mmHg. Primary and secondary outcomes will be measured at baseline and at 3 1/2, 6 1/2, and eight months. Other measurements will be performed at baseline and eight months.


DISCUSSION
The findings will provide new knowledge on how to improve blood pressure control and patient adherence in ethnic minority persons with a high risk of negative hypertension-related health outcomes.


TRIAL REGISTRATION
ISRCTN35675524.