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 Reducing stroke burden through a targeted self-management intervention for reducing stroke risk factors in high-risk Ugandans: A protocol for a randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0251662
Author(s):  
Mark Kaddumukasa ◽  
Josephine Najjuma ◽  
Scovia Nalugo Mbalinda ◽  
Martin N. Kaddumukasa ◽  
Jane Nakibuuka ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomized Controlled Trial ◽  
Risk Reduction ◽  
Stroke Risk ◽  
Controlled Trial ◽  
Self Management ◽  
Primary Study ◽  
Management Intervention ◽  
Stroke Risk Factors ◽  
Randomized Controlled

Introduction Stroke burden is rapidly increasing globally. Modifiable risk factors offer an opportunity to intervene, and targeting hypertension is a key actionable target for stroke risk reduction in sub-Saharan Africa. This 3-site planned randomized controlled trial builds on promising preliminary data. Methods A total of 246 Ugandan adults will be recruited randomized to experimental intervention vs. enhanced treatment control. Intervention participants will receive six weekly group-format stroke risk reduction self-management training sessions, and the controls will receive information on cardiovascular risk. The primary study outcome is systolic B.P. measured at baseline, 13-week, 24 weeks (6 months). Secondary outcomes include other biological and behavioral stroke risk factors. Discussion The curriculum-guided self-management TargetEd MAnageMent Intervention (TEAM) program is anticipated to reduce the stroke burden in Uganda. Trial registration ClinicalTrials.gov identifier: NCT04685408, registered on 28 December 2020.

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

A Pharmacist-Led Stroke Education and Screening Program for Community-Dwelling Older Adults

2019 ◽  
Vol 34 (2) ◽  
pp. 127-142
Author(s):  
Marketa Marvanova ◽  
Paul Jacob Henkel
Keyword(s):  
Risk Factors ◽  
Health Status ◽  
Stroke Prevention ◽  
Stroke Risk ◽  
Community Dwelling ◽  
Warning Signs ◽  
Secondary Stroke Prevention ◽  
Stroke Risk Factors ◽  
Stroke Knowledge ◽  
Study Questionnaire

OBJECTIVES: To deliver a pharmacist-led education and screening for community-dwelling residents, assess the effect of this initiative on knowledge of stroke risk factors and warning signs, and evaluate the stroke-knowledge and risk-assessment questionnaire as a tool to identify stroke-related health status and identify need(s) for specific clinical intervention(s) to decrease risk.<br/> DESIGN: The 70-minute-long event comprised: brief introduction/informed consent, baseline assessment of stroke knowledge, completion of study questionnaire, single blood pressure and heart rate readings, presentation, question-and-answer session, postsurvey questionnaire items.<br/> SETTING: Four faith-based institutions in the Midwest.<br/> PARTICIPANTS: Independent community-dwelling adults 18 years of age and older (N = 97), 89.7% 60 years of age and older.<br/> INTERVENTIONS: Thirty-minute presentation followed by question-and-answer session on ischemic stroke. Screening for primary and secondary stroke-prevention status using study questionnaire and vital signs.<br/> MAIN OUTCOME MEASURE(S): Stroke knowledge regarding modifiable stroke-risk factors and acute stroke-warning signs, individual primary/secondary stroke-prevention status.<br/> RESULTS: Postintervention, mean number of modifiable stroke risk factors (2.6 ± 0.8) and warning signs (2.6 ± 0.8) named improved from preintervention (P < 0.001) including for most subgroups (i.e., self-reported hypertension, atrial fibrillation [AF], or high number of personal risk factors). Needs for improved primary/secondary prevention were identified for blood-measure control and antilipidemic therapy. No disparity was observed regarding thrombotic therapy in participants with AF.<br/> CONCLUSION: The program was resource-efficient, involved student pharmacists, improved immediate stroke-related knowledge of participants including those with increased risk(s) of stroke, and demonstrated value for evaluating stroke-related health status and identifying need for primary and secondary stroke prevention.

Abstract P886: Differences in Medication Utilization for Secondary Stroke Prevention Between Ghanaian Stroke Patients and Stroke Patients in the United States

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Esther Olasoji ◽  
FRED S SARFO ◽  
Alexis Simpkins
Keyword(s):  
Risk Factors ◽  
Stroke Prevention ◽  
Stroke Risk ◽  
The United States ◽  
Rural Setting ◽  
Secondary Stroke Prevention ◽  
Stroke Patients ◽  
Stroke Risk Factors ◽  
Medication Utilization ◽  
Oral Agents

Introduction: Optimization of secondary stroke prevention is an essential part of stroke care globally. We sought to assess differences in medication utilization between African Americans (AA), Non-Hispanic Whites (NW), and Ghanaians in addition to effects related to location of residence (rural versus urban). Methods: Data from the UFHealth institutional stroke database and the Kumasi, Ghana Stroke Survivors Registry between 01/2014 and 11/2019 provided a dataset of adult patients diagnosed with stroke from both locations. Multivariate regression analysis identified differences between country of origin, race, patient demographics, location of residence, stroke risk factors, and clinical management following stroke. Results: Of the 5519 patients studied, the median age was 66 (IQR 45 - 87), 16% were AA, 19% Ghanaian, 66% NW, and 51% were male. After controlling for age, sex, stroke type, and stroke risk factors, we found that in comparison to the AA and NW, patients from Ghana were more likely to be prescribed angiotensin converting enzyme (ACE) inhibitors (OR 1.42, 1.05-1.93 95% CI), angiotensin receptor blockers (ARB) (OR 18.36, 13.08-25.78 95% CI), calcium channel blockers (CCB) (OR 8.35, 6.30-11.08 95% CI), statin (OR 3.26, 2.26-4.59 95% CI), anti-diabetic oral agents (OR 7.18, 4.21-12.27 95% CI); less likely to be prescribed anticoagulant (OR 0.22, 0.12-0.40 95% CI), beta blockers (BB) (OR 0.15, 0.11-0.21 95% CI), and insulin (OR 0.11, 0.06-0.20 95% CI). In comparison to AA, Ghanaians were more likely to be prescribed statin (OR 3.06, 1.93-4.86 95% CI), ARBs (OR 22.87, 13.85-37.79 95% CI), CCBs (OR 5.83, 3.94-8.62 95% CI), anti-diabetic oral agents (OR 8.89, 4.25-18.59 95% CI); less likely to live in an urban vs rural setting (OR 0.64, 0.46-0.89 95% CI), be prescribed anticoagulant (OR 0.28, 0.14-0.55 95% CI), BBs (OR 0.13, 0.0.09-0.19 95% CI), and insulin (OR 0.11, 0.05-0.23 95% CI). Conclusion: In conclusion, we found significant differences in the prevalence of medications prescribed for stroke prevention between Ghana and the U.S. Further research is needed to determine if these differences result in consequential differences in stroke reoccurrence between these populations.

scholarly journals The effect of mobile text messages on knowledge and perception towards cancer and behavioral risks among college students, Northeast Ethiopia: A randomized controlled trial protocol

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0253839
Author(s):  
Foziya Mohammed Hussien ◽  
Anissa Mohammed Hassen ◽  
Zinet Abegaz Asfaw ◽  
Aragaw Yimer Ahmed ◽  
Hamid Yimam Hassen
Keyword(s):  
Risk Factors ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Cancer Risk ◽  
Controlled Trial ◽  
Health Belief ◽  
Text Messages ◽  
Public Colleges ◽  
Randomized Controlled ◽  
Northeast Ethiopia

Background Cancer is an emerging public health problem in Ethiopia. A significant proportion of premature cancer deaths are preventable. The socioeconomic impact of cancer can be considerably reduced provided that effective interventions are put in place to control risk factors. Text-messaging has been currently targeted as a simple and efficient tool for providing people with health information. Objective To evaluate the effectiveness of mobile text messages in improving knowledge and perception on cancer and behavioral risks among college students. Methods Design: a single-blind, 2-arm randomized controlled trial will be used. Setting: the study will be conducted among public colleges in Dessie town, Northeast Ethiopia. Study population: students who are studying in all public colleges. Intervention: a text message related to cancer risk factors once a day for two months. Control groups will receive general health messages daily for two months. Data: Socioeconomic characteristics, health belief variables, and behavioral risk factors of cancer will be collected before and after the intervention. Text messages will be provided based on the health belief model (HBM). Primary outcomes: cancer risk knowledge score and risk perception will be measured at baseline and 6 months post-randomization. Secondary outcomes: a change in mean healthy diet score, physical activity level, alcohol intake, and tobacco use will be measured at baseline-, 3, and 6 months post-randomization. Analysis: We will compute descriptive statistics for each outcome pre and post-intervention. To test the change in knowledge and perception, paired t-test will be used. Analysis of Covariance will be used to test over group comparison. Trial registration ClinicalTrials.gov (https://register.clinicaltrials.gov) NCT04269018.

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