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

ABSTRACT: 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. TRIAL REGISTRATION:ClinicalTrials.gov NCT02251834; https://clinicaltrials.gov/ct2/show/NCT02251834 (Archived by WebCite at http://www.webcitation.org/72DgMqftq). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR1-10.2196/11083.

SUBMITTER: Carrasquillo O

PROVIDER: S-EPMC6231896 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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

Carrasquillo Olveen O Young BreAnne B Dang Stuti S Fontan Orieta O Ferras Natalie N Romano Jose G JG Dong Chuanhui C Kenya Sonjia S

JMIR research protocols 20181019 10

<h4>Background</h4>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).<h4>Objective</h4>The objective of this randomized controlled trial is to evaluate the effectiveness of a CHW intervention among Latino patients at risk of recurrent stroke.<h4>Methods</h4 ...[more]

PMID: 30341050

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Project description:BackgroundMost patients with minor stroke or transient ischemic attack (TIA) are discharged with little or no specialised follow-up. Nonetheless, these patients have a high prevalence of cognitive impairments and a considerable risk of recurrent stroke. Smoking cessation, physical activity, and adherence to antihypertensive and antithrombotic medication are highly recommended in patients with minor stroke and TIA. Evidence suggests that simple encouragement to change lifestyle is ineffective. Behavioural interventions might therefore be needed to support patients in managing their own health post-discharge.ObjectivesWe aim to test the (1) feasibility of randomisation acceptance and an early initiated, client-centred lifestyle and behavioural intervention in a clinical setting, and (2) potential effect of the intervention on arterial blood pressure in patients with minor stroke or TIA and (3) explore the participants experience of barriers and facilitators for health behaviour after a stroke, including perceived needs and social support.MethodsWe will conduct a randomized controlled pilot trial: Eligible patients with acute minor stroke or TIA (n = 40) will be randomly allocated to either early initiated counselling with four weekly post-discharge follow-up sessions for 12 weeks or usual care. The primary outcome will be program feasibility and to discuss the relevance of arterial blood pressure as primary outcome after 12 weeks intervention. Selected participants will be invited to participate in semi-structured interviews, based on purposeful sampling, to evaluate the intervention and explore their experience of life after a stroke. The interviews will be analysed using a five-step thematic analysis approach.DiscussionThe study will provide evidence of the feasibility and potential effect of early initiated counselling on cardiovascular risk factors in patients with minor stroke and TIA. Qualitative interviews will contribute with a more nuanced understanding of the barriers and facilitators of health enhancing behaviour. Optimizing health behaviour counselling and providing formal support to the patients' post-discharge may ease the transition and help more patients adhere to lifestyle and medication recommendations.Trial registrationClinicalTrial.gov, NCT03648957.

Project description:BackgroundSetting up a follow-up secondary prevention program after stroke is difficult due to motor and cognitive impairment, but necessary to prevent recurrence and improve patients' quality of life. To involve a referent nurse and a caregiver from the patient's social circle in nurse-led multimodal and long-term management of risk factors after stroke could be an advantage due to their easier access to the patient and family. The aim of this study is to compare the benefit of optimized follow up by nursing personnel from the vascular neurology department including therapeutic follow up, and an interventional program directed to the patient and a caregiving member of their social circle, as compared with typical follow up in order to develop a specific follow-up program of secondary prevention of stroke.Methods/designThe design is a randomized, controlled, clinical trial conducted in the French Stroke Unit of the Strokavenir network. In total, 410 patients will be recruited and randomized in optimized follow up or usual follow up for 2 years. In both group, patients will be seen by a neurologist at 6, 12 and 24 months. The optimized follow up will include follow up by a nurse from the vascular neurology department, including therapeutic follow up, and a training program on secondary prevention directed to the patient and a caregiving member of their social circle. After discharge, a monthly telephone interview, in the first year and every 3 months in the second year, will be performed by the nurse. At 6, 12 and 24 month, the nurse will give the patient and caregiver another training session. Usual follow up is only done by the patient's general practitioner, after classical information on secondary prevention of risk factors during hospitalization. The primary outcome measure is blood pressure measured after the first year of follow up. Blood pressure will be measured by nursing personnel who do not know the group into which the patient has been randomized. Secondary endpoints are associated mortality, morbidity, recurrence, drug side-effects and medico-economic analysis.DiscussionThe result of this trial is expected to provide the benefit of a nurse-led optimized multimodal and long-term interventional program for management of risk factors after stroke, personalizing the role of the nurse and including the patient's caregiver.Trial registrationClinicalTrials.gov, NCT 02132364. Registered on 7 May 2014. EUDRACT, A 00473-40.

Project description:BACKGROUND:In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. OBJECTIVE:Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. METHODS:Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. RESULTS:A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. CONCLUSIONS:The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. TRIAL REGISTRATION:ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo).

Dataset Information

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

Publications

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

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