Primary research aim
The aim of the trial is to reduce population levels of uncontrolled hypertension, especially in those individuals at greatest risk, by supporting and strengthening the management of hypertension in primary care clinics
Research objectives and methodology
The research objectives of the trial are to:
- Compare the effectiveness of clinic based lay health workers to ‘usual care’, in improving the management of hypertension (including access to care, adherence to treatment, and management), in rural South Africa.
- Conduct a realist evaluation to understand the patient, intervention, implementation, health system and community barriers and facilitators that explain patient outcomes in the intervention and ‘usual care’ clinics.
- Contribute specific recommendations to strengthen policy and practice in similar rural settings of South and Southern Africa.
The trial involves randomising clinics to receive support from lay health workers (LHW). Four clinics will be randomised to receive the LHWs, and four will be control clinics. The outcome of the trial will be assessed by two population based cross sectional surveys; one at baseline and one at the end of the intervention. The surveys will collect data on cardiovascular risk factors, use of clinics, and current medication, as well as measuring blood pressure. The hypothesis is that the LHWs will improve clinic functioning, thus encouraging more use of the clinics and more consistent use of medication for high blood pressure. Alongside the trial there will be a system linking the clinic records and the existing Health and Demographic Survey System database, enabling us to collect patient specific data on clinic use. There will also be an extensive process evaluation involving interviews with nurses, clinic managers and supervisors, LHWs, and our implementation manager. We are also carrying out observations in the clinics, conducting patient exit interviews and interviewing three purposely selected samples of clinic users.
The baseline survey has been completed. The LHWs have been in the clinics since early 2014. The intervention will end in August 2015. As of March 2015, we have completed about 60% of the planned process evaluation. The outcome survey will start in September 2015.
- Margaret Thorogood, University of Warwick, Coventry, UK and University of the Witwatersrand, Johannesburg, South Africa
- Jane Goudge, University of the Witwatersrand, Johannesburg, South Africa
- Felix Limbani, University of the Witwatersrand, Johannesburg, South Africa
- Nokuzola Myakayaka, University of the Witwatersrand, Johannesburg, South Africa
- Chodziwadziwa Kabudula, University of the Witwatersrand, Johannesburg, South Africa
- Nkosinathi Masilela, University of the Witwatersrand, Johannesburg, South Africa
- F. Xavier Gómez-Olivé, University of the Witwatersrand, Johannesburg, South Africa
- Thorogood M, Goudge J, Bertram M, Chirwa T, Eldridge S, Gomez-Olive FX, et al. The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial. Trials. 2014; 15: 435
- Medical Research Council, United Kingdom
Dr Margaret Thorogood