scholarly journals A randomized controlled trial of brain and heart health manager-led mHealth secondary stroke prevention

2020 ◽  
Vol 10 (5) ◽  
pp. 1192-1199
Author(s):  
Shasha Wang ◽  
Ying Li ◽  
Jishu Tian ◽  
Xiaoqiong Peng ◽  
Ling Yi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stroke Prevention ◽  
Controlled Trial ◽  
Secondary Stroke Prevention ◽  
Heart Health ◽  
Randomized Controlled ◽  
Health Manager

scholarly journals Hispanic Secondary Stroke Prevention Initiative Design: Study Protocol and Rationale for a Randomized Controlled Trial

10.2196/11083 ◽  
2018 ◽  
Vol 7 (10) ◽  
pp. e11083
Author(s):  
Olveen Carrasquillo ◽  
BreAnne Young ◽  
Stuti Dang ◽  
Orieta Fontan ◽  
Natalie Ferras ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Stroke Prevention ◽  
Controlled Trial ◽  
Secondary Stroke Prevention ◽  
Design Study ◽  
Randomized Controlled

scholarly journals Low- Versus Moderate-Dose Hydroxyurea for Secondary Stroke Prevention in Children with Sickle Cell Disease in Sub-Saharan Africa: Final Results of a Randomized Controlled Trial, Sprint Trial

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 5-6
Author(s):  
Shehu Umar Abdullahi ◽  
Surayya M. Sunusi ◽  
Mohammed Sani Abba ◽  
Saifuddeen Sani ◽  
Aisha Galadanci ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Transfusion ◽  
Incidence Rate ◽  
Stroke Prevention ◽  
Low Dose ◽  
Controlled Trial ◽  
Secondary Stroke Prevention ◽  
Moderate Dose ◽  
Transfusion Therapy ◽  
Randomized Controlled

Introduction Strokes are a preventable cause of neurological morbidity and premature death, particularly in children with sickle cell anemia (SCA) living in low-resource countries. If untreated, 50% of children with SCA their first overt ischemic stroke will have a recurrent stroke within two years of the event. In high-income countries, ASH 2020 guidelines recommend indefinite regular blood transfusion therapy for secondary stroke prevention (Blood Adv. 2020). Unfortunately, regular blood transfusion therapy is not a feasible option for children with SCA in sub-Saharan Africa due to the high cost of monthly blood transfusion, limited blood supply, and unsafe transfusion practices. Also, children who receive regular blood transfusions will ultimately require daily iron chelation at a cost that is prohibitive to most families in low-income settings. One randomized controlled trial provided evidence that HU therapy may be an effective therapy for secondary prevention of strokes when compared to no therapy (Blood. 2012;119(17):3925-3932). In the SWiTCH trial, the incidence rate of stroke recurrence in the group randomly allocated to receive maximum tolerated dose HU therapy was significantly higher than the group randomly assigned to receive blood transfusion therapy (5.6 and 0 events per 100 person-years, respectively, but considerably lower when compared to children not treated with any treatment, approximately 28 events per 100 person-years (Niger Postgrad Med J. 2013;20(3):181-187). Given the practical limitations for regular blood transfusion therapy, we tested the hypothesis that for secondary stroke prevention among children with SCA and acute overt ischemic stroke, fixed moderated dose HU therapy (~20 mg/kg/day) results in 80% relative risk reduction when compared to fixed low-dose HU therapy (10 mg/kg/day) in a randomized controlled trial (SPRINT Trial; NCT02675790). Methodology In phase III controlled trial, partially blind d controlled trial, we randomly assigned children 1 - 16 years of age with SCA and a new-onset of ischemic stroke (within 1 month) to receive fixed moderate-dose HU therapy at 20 mg/kg/day or fixed-low dose HU therapy at 10 mg/kg/day) with a monthly follow-up for at least 36 months. The primary endpoint was a recurrence of overt stroke or transient ischemic attack. Myelosuppression was assessed with monthly CBCs. Adherence to hydroxyurea was based on an increase in MCV from baseline and monthly pill count return, as a percent of dispensed pills. Results A total of 101 children with SCA were randomly assigned to fixed low- (~10 mg/kg/day) or moderate- (~20 mg/kg/day) dose hydroxyurea. The mean age was 6.6 years; 55.4% were males, and the median follow up was 1.6 years (IQR 1.0 - 2.3). The DSMB stopped the trial early due to the futility of the primary endpoint. In the fixed low- and moderate-dose groups, the incidence rates of recurrent strokes per 100 person-years were 7.1 and 6.0, respectively, incidence rate ratio of 0.85 (95% CI: 0.20 - 3.34), p=0.999. The incidence rates of mortality per 100 person-years in the fixed low dose and moderate- fixed-dose groups were 2.38 and 3.63, respectively, with an incidence rate ratio of 1.53 (95% CI: 0.18 - 18.30), p=0.98. No participant had hydroxyurea therapy stopped because of myelosuppression. As a measure of adherence, MCV from baseline to endpoint increased 6.2 fl and 13.3 fl in the fixed low- and moderate-dose groups, respectively, p=0.025; returned pills during the trial were 3.3% and 3.5% in the fixed low- and moderate-dose groups, respectively, p= 0.76. Conclusion For secondary stroke prevention, in a randomized controlled trial in children with SCA and new onset of ischemic strokes, fixed low-dose, when compared to fixed moderate-dose hydroxyurea therapy, demonstrated no difference in the incidence rate of stroke recurrence. Fixed low-dose hydroxyurea for secondary prevention of strokes in Nigeria provided similar stroke recurrence rate, when compared to the SWiTCH Trial (Blood. 2012;119(17):3925-3932) with the maximum tolerated dose of hydroxyurea of 7.0 and 5.7 events per 100 person-years, respectively. For secondary stroke prevention, in low-income settings without access to indefinite regular blood transfusion therapy, fixed low-dose hydroxyurea of at least 10 mg/kg/day with biannual CBC is a new evidence-based strategy to prevent strokes and minimize unnecessary laboratory testing. Disclosures DeBaun: Global Blood Therapeutics (GBT): Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. OffLabel Disclosure: fixed low and moderate dose hydroxyurea for primary stroke prevention in sickle cell

scholarly journals Hispanic Secondary Stroke Prevention Initiative Design: Study Protocol and Rationale for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Olveen Carrasquillo ◽  
BreAnne Young ◽  
Stuti Dang ◽  
Orieta Fontan ◽  
Natalie Ferras ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomized Controlled Trial ◽  
Stroke Prevention ◽  
Stroke Risk ◽  
Controlled Trial ◽  
Text Messages ◽  
South Florida ◽  
Secondary Stroke Prevention ◽  
Stroke Risk Factors ◽  
Randomized Controlled

BACKGROUND Hispanic-Latino populations face a disproportionate stroke burden and are less likely to have sufficient control over stroke risk factors in comparison with other ethnic populations. A promising approach to improving chronic health outcomes has been the use of community health workers (CHWs). OBJECTIVE The objective of this randomized controlled trial is to evaluate the effectiveness of a CHW intervention among Latino patients at risk of recurrent stroke. METHODS The Hispanic Secondary Stroke Prevention Initiative (HiSSPI) is a randomized clinical trial of 300 Latino participants from South Florida who have experienced a stroke within the last 5 years. Participants randomized into the CHW intervention arm receive health education and assistance with health care navigation and social services through home visits and phone calls. The intervention also includes a mHealth component in which participants also receive daily text messages (short message service). The primary outcome is change in systolic blood pressure at 12 months. Other secondary outcomes include changes in low-density lipoprotein, glycated hemoglobin, and medication adherence. RESULTS Study enrollment began in 2015 and will be completed by the end of 2018. The first results are expected to be submitted for publication in 2020. CONCLUSIONS HiSSPI is one of the first randomized controlled trials to examine CHW-facilitated stroke prevention and will provide rigorous evidence on the impact of CHWs on secondary stroke risk factors among Latino individuals who have had a stroke. CLINICALTRIAL ClinicalTrials.gov NCT02251834; https://clinicaltrials.gov/ct2/show/NCT02251834 (Archived by WebCite at http://www.webcitation.org/72DgMqftq) INTERNATIONAL REGISTERED REPOR RR1-10.2196/11083

scholarly journals Translating research to usual care of children with sickle cell disease in Northern Nigeria: lessons learned from the SPRING Trial Team

2022 ◽  
Vol 15 (1) ◽  
Author(s):  
Halima Bello-Manga ◽  
Lawal Haliru ◽  
Abdulkadir M. Tabari ◽  
Bilkisu Farouk ◽  
Aisha Suleiman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sickle Cell ◽  
Organizational Support ◽  
Stroke Prevention ◽  
Controlled Trial ◽  
Routine Practice ◽  
Northern Nigeria ◽  
Randomized Controlled

Abstract Objectives Evidence-based practice for stroke prevention in high-income countries involves screening for abnormal transcranial Doppler (TCD) velocity and initiating regular blood transfusions for at least 1 year, followed by treatment with hydroxyurea. This practice has not been transferred to low-resource settings like Nigeria, the country with the highest global population density of SCD. Following a multi-center randomized controlled trial among children with SCA in northern Nigeria, screening for stroke and initiation of hydroxyurea was established as standard of care at the clinical trial sites and other locations. We aim to describe the critical steps we took in translating research into practice for stroke prevention in SCA in Nigeria. Guided by the PRISM framework, we describe how we translated results from a randomized controlled trial for primary prevention of stroke in children with sickle cell anemia into usual care for children with SCA in Kaduna, Nigeria. Results Findings from this study demonstrate the importance of organizational support and stakeholder involvement from the onset of a clinical trial. Having the dual objective of conducting an efficacy trial while simultaneously focusing on strategies for future implementation can significantly decrease the lag time between discovery and routine practice.

scholarly journals Case management for blood pressure and lipid level control after minor stroke: PREVENTION randomized controlled trial

2014 ◽  
Vol 186 (8) ◽  
pp. 577-584 ◽  
Author(s):  
F. A. McAlister ◽  
S. R. Majumdar ◽  
R. S. Padwal ◽  
M. Fradette ◽  
A. Thompson ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Case Management ◽  
Stroke Prevention ◽  
Controlled Trial ◽  
Lipid Level ◽  
Minor Stroke ◽  
Level Control ◽  
Randomized Controlled
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