Primary research aim
The need to improve stroke preventative care is particularly pressing in developing countries where resources are few and the burden of stroke is disproportionately heavy. The overall aim of Tailored Hospital-based Risk Reduction to Impede Vascular Events after Stroke (THRIVES) is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in Nigeria. THRIVES has unfolded into five distinct phases:
- Pretest qualitative
- Main qualitative (focus group discussions and semi-structured interviews)
- Intervention tailoring and redesign
- Randomized clinical trial
- Translation to institutional/governmental policy
Research objectives and methodology
The research objective for the RCT phase of the THRIVES project is to conduct a randomized clinical trial of the developed THRIVES intervention vs. standard post discharge management in stroke patients discharged from four hospitals in Nigeria. The primary outcome will be a significant reduction in systolic blood pressure at one year. Other study objectives will evaluate whether the intervention shows a signal of potential efficacy in reducing the rate of subsequent primary vascular events and investigate whether the intervention compared with usual and customary care will reduce functional disability and enhance quality of life at one year. The final objective is to estimate, in a preliminary fashion, the cost-impact and cost-effectiveness of the THRIVES post discharge intervention, compared with usual and customary care. The multi-pronged intervention involves the use of a patient video therapy, patient report card, and text messages. The patient interactive video therapy will be adapted and produced in three languages (English, Yoruba and Pidgin English) in tandem with the primary languages of the study population. A THRIVES Task Force will evaluate and review all materials produced.
The pre-test qualitative, main qualitative, and intervention tailoring phases are complete. The RCT phase is ongoing. With the data provided through semi-structured interviews, focus groups and a community based task force, the patient tools were refined to be culturally appropriate (the tools are relevant, easy to read/use, and informative).
Prior to the commencement of the RCT phase of THRIVES study, specific strategies ranging from provision of Technical Advice, Advocacy and Capacity building were incorporated in a bid to ensure a smooth implementation process. With respect to provision of technical advice, consecutive, intensive and rigorous intervention validations sessions were conducted and championed by a multidisciplinary committee (task force committee) comprising physician investigators, statisticians, pharmacists, educators, social workers, nurses, telecommunication experts, dieticians, physical therapists, administrators, and religious, community representatives, government and Nigerian Stroke Society. Constituted to review and make recommendations to the RCT phase of THRIVES study, THRIVES intervention (patient report card, mobile text messaging and in-clinic educational video) underwent refinement and validation. As a result, the interventions evolved to a readable patient report card with targets reflecting evidence based stroke risk factor control recommendations, clarification of personnel responsible for specific tasks; identification of cost effective structures appropriate for delivery of messages, and for the video the development of dynamic educational tool consistent with the African culture and lifestyle.
Pilot testing of the refined report card was carried out among non-stroke patients at the University College Hospital, Nigeria by neurologists in the study. From an advocacy point of view, a familiarization visit was paid earlier this year to key stakeholders at the University College Hospital, Ibadan, Nigeria by the Principal Investigator of THRIVES study. He solicited the stakeholders’ unflinching support for the second phase of THRIVES study. Furthermore, capacity building sessions were conducted for specific subsets of personnel who will be involved in the study. Trained by an array of specialists and investigators on the study, blinded adjudicators with background in public health were sensitized to the need to collect independent and objective outcome data from enrolled subjects at the various time points of the study. In addition, all clinicians across all four sites of the study were brought up to speed with expectations and assigned tasks in the course of the study.
The THRIVES project has now entered the RCT phase. Recruitment of potential subjects has begun in earnest from the hospitals, and a potential subjects database that has been in construction since the onset of the project. Subjects are being consented and enrolled. This phase of the project will provide data on the efficacy of the study tools (patient video, patient report card, and text messages).
- Medical University of South Carolina (USA) – Prof Bruce Ovbiagele
- UC San Diego (USA) – Dr Rema Raman and Dr Samantha Hurst
- University of Ibadan (Nigeria) – Dr Mayowa Owolabi, Dr Rufus Akinyemi, Dr Oyedunni Arulogun, Dr Lanre Loaniyan and Dr Tunde Salako
- Owolabi, M., Olowoyo, P., Miranda, J. J., Akinyemi, R., Feng, W., Yaria, J., . . . Ovbiagele, B. (2016). Gaps in Hypertension Guidelines in Low- and Middle-Income Versus High-Income Countries: A Systematic Review. Hypertension. doi:10.1161/hypertensionaha.116.08290
- Arulogun, O. S., Hurst, S., Owolabi, M. O., Akinyemi, R. O., Uvere, E., Saulson, R., & Ovbiagele, B. Experience of using an interdisciplinary task force to develop a culturally sensitive multipronged tool to improve stroke outcomes in Nigeria. eNeurologicalSci. doi:10.1016/j.ensci.2016.04.003
- Hurst, S., Arulogun, O. S., Owolabi, a. O., Akinyemi, R., Uvere, E., Warth, S., & Ovbiagele, B. (2015). Pretesting Qualitative Data Collection Procedures to Facilitate Methodological Adherence and Team Building in Nigeria. International journal of qualitative methods, 14, 53-64. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393011/
- Olaniyan O, Mayowa O, Rufus A, et al. Cost and cost-effectiveness analysis of a bundled intervention to enhance outcomes after stroke in Nigeria: Rationale and design. eNeurologicalSci. 2015 1(2): 38-45.
- Owolabi MO, Akinyemi RO, Gebregziabher M, Olaniyan O, Salako BL, Arulogun O, et al. Randomized controlled trial of a multipronged intervention to improve blood pressure control among stroke survivors in Nigeria. International journal of stroke : official journal of the International Stroke Society. 2014; 9(8): 1109-16
- Owolabi MO, Akinyemi RO, Hurst S, Arulogun O, Olaniyan O, Gebregziabher M, et al. Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke (THRIVES) study: qualitative phase protocol. Critical pathways in cardiology. 2014; 13(1): 29-35
- National Institutes of Health, United States
- National Institute of Neurological Disorders and Stroke, United States