Randomized Trial of an Intervention to Improve Blood Pressure Control in Stroke Survivors

Abstract

Background: We conducted the first-of-its kind randomized stroke trial in Africa to test whether a THRIVES (Tailored Hospital-based Risk reduction to Impede Vascular Events after Stroke) intervention improved blood pressure (BP) control among patients with stroke. Methods and Results: Intervention comprised a patient global risk factor control report card, personalized phone text-messaging, and educational video. Four hundred patients recruited from 4 distinct medical facilities in Nigeria, aged ≥18 years with stroke-onset within one-year, were randomized to THRIVES intervention and control group. The control group also received text messages, and both groups received modest financial incentives. The primary outcome was mean change in systolic BP (SBP) at 12 months. There were 36.5% females, 72.3% with ischemic stroke; mean age was 57.2±11.7 years; 93.5% had hypertension and mean SBP was 138.33 (23.64) mm Hg. At 12 months, there was no significant difference in SBP reduction from baseline in the THRIVES versus control group (2.32 versus 2.01 mm Hg, P =0.82). In an exploratory analysis of subjects with baseline BP >140/90 mm Hg (n=168), THRIVES showed a significant mean SBP (diastolic BP) decrease of 11.7 (7.0) mm Hg while control group showed a significant mean SBP (diastolic BP) decrease of 11.2 (7.9) mm Hg at 12 months. Conclusions: THRIVES intervention did not significantly reduce SBP compared with controls. However, there was similar significant decrease in mean BP in both treatment arms in the subgroup with baseline hypertension. As text-messaging and a modest financial incentive were the common elements between both treatment arms, further research is required to establish whether these measures alone can improve BP control among stroke survivors. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01900756.

Stroke in Africa: profile, progress, prospects and priorities

“…After 12 months of administration, systolic blood pressure in the group of participants receiving the THRIVES was not significantly lower than in the group of participants receiving usual care. However, in a sub-group of participants with uncontrolled blood pressure, both usual care and the THRIVES intervention were associated with a reduction in blood pressure, in both arms, compared with the pre-treatment baseline 294 . An ongoing secondary prevention trial — the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial — is a phase II, open-label, evaluator-blinded trial involving 120 participants from Ghana who have recently survived a stroke.…”

“…Among non-neurologist health workers 292 and adolescent students 293 , stroke-based educational interventions were associated with substantial improvement in stroke literacy. We have also previously shown the feasibility of an educational mobile phone short messaging service (SMS) including information on stroke for the control of blood pressure among West African survivors of stroke 294 , 295 . Across multiple sites in Nigeria and Ghana, treatment choices were found to be influenced by beliefs about stroke causation, and the development of culturally sensitive and acceptable community-based educational interventions was necessary for the reduction of stroke burden 291 .…”

“Lessons Learned” Preventing Recurrent Ischemic Strokes through Secondary Prevention Programs: A Systematic Review

“…Masterstroke combined education with exercise and was able to demonstrate short-term effectiveness, making it the only study of this nature to be effective [ 15 ]. Equally as many programs focusing solely on adherence to the care plan or inclusive combinations were deemed not effective (Adie et al and Feldman et al Motivational Interviewing, Point of Care Electronic Health Record (EHR) prompt, Outreach Nursing, PREVENT, DMP, STARS-Plus, PRAISE, THRIVES, BRIDGE Stroke) [ 6 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 ]. Most programs that focused on education or education plus physical activity were not effective (SEP, ICMP, Education and Support Package, High-Intensive Exercise Program, Denny et al) [ 32 , 33 , 34 , 35 , 36 ].…”

“…Studies that utilized a virtual component of delivery were effective in three cases (SMART, DESERVE, Kim et al) and not effective in five cases (ICMP, THRIVES, Point of Care EHR Prompt, Ticaa’dom, Denny et al) [ 16 , 17 , 25 , 30 , 33 , 36 , 42 , 43 ]. Studies that complemented their strategy with written materials were more often unsuccessful (Education and Support Package, DMP, PRAISE, THRIVES, BRIDGE Stroke, Point of Care EHR Prompt) than successful (Comprehensive Reminder System, DESERVE, PROTECT) [ 14 , 17 , 23 , 26 , 29 , 30 , 31 , 35 , 43 ]. Only three studies had an automated component: Comprehensive Reminder System and PINGS were short-term effective, whereas THRIVES was not effective [ 31 , 40 , 41 , 43 ].…”

Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial

“…However, primary care providers in LMICs often focus on infectious diseases and maternal and child health; thus, there is a lack of capacity to provide evidence-based essential primary care for patients with NCDs [3]. Several dozen trials have been conducted to evaluate various human-based or technological approaches to strengthen primary care for NCD control [4][5][6][7][8][9]. According to recent systematic reviews, these trials as a whole were effective in improving the quality of primary and community-based care, while results from mobile health (mHealth) technological interventions, mainly message-based programs, were inconclusive [8][9][10][11].…”