Dataset Information

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

ABSTRACT: The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans.Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level.Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (-123.17 mg/d [-194.76, -51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (-27 metabolic equivalent-minutes per week [-526, 471], P=0.56).This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.

SUBMITTER: Brown DL

PROVIDER: S-EPMC4589523 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

Brown Devin L DL Conley Kathleen M KM Sánchez Brisa N BN Resnicow Kenneth K Cowdery Joan E JE Sais Emma E Murphy Jillian J Skolarus Lesli E LE Lisabeth Lynda D LD Morgenstern Lewis B LB

Stroke 20150915 10

<h4>Background and purpose</h4>The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans.<h4>Methods</h4>Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tail ...[more]

PMID: 26374480

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Project description:BackgroundCurrent benzodiazepine (BZD) prescription guidelines recommend short-term use to minimize the risk of dependence, cognitive impairment, and falls and fractures. However, many clinicians overprescribe BZDs and chronic use by patients is common. There is limited evidence on the effectiveness of interventions delivered by general practitioners (GPs) on reducing prescriptions and long-term use of BZDs. We aimed to evaluate the effectiveness of a multicomponent intervention for GPs that seeks to reduce BZD prescriptions and the prevalence of long-term users.Methods and findingsWe conducted a multicenter two-arm, cluster randomized controlled trial in 3 health districts in Spain (primary health centers [PHCs] in Balearic Islands, Catalonia, and Valencian Community) from September 2016 to May 2018. The 81 PHCs were randomly allocated to the intervention group (n = 41; 372 GPs) or the control group (n = 40; 377 GPs). GPs were not blinded to the allocation; however, pharmacists, researchers, and trial statisticians were blinded to the allocation arm. The intervention consisted of a workshop about the appropriate prescribing of BZDs and tapering-off long-term BZD use using a tailored stepped dose reduction with monthly BZD prescription feedback and access to a support web page. The primary outcome, based on 700 GPs (351 in the control group and 349 in the intervention group), compared changes in BZD prescriptions in defined daily doses (DDDs) per 1,000 inhabitants per day after 12 months. The 2 secondary outcomes were the proportion of long-term users (≥6 months) and the proportion of long-term users over age 65 years. Intention-to-treat (ITT) analysis was used to assess all clinical outcomes. Forty-nine GPs (21 intervention group and 28 control group) were lost to follow-up. However, all GPs were included in the ITT analysis. After 12 months, there were a statistically significant decline in total BZD prescription in the intervention group compared to the control group (mean difference: -3.24 DDDs per 1,000 inhabitants per day, 95% confidence interval (CI): -4.96, -1.53, p < 0.001). The intervention group also had a smaller number of long-term users. The adjusted absolute difference overall was -0.36 (95% CI: -0.55, -0.16, p > 0.001), and the adjusted absolute difference in long-term users over age 65 years was -0.87 (95% CI: -1.44, -0.30, p = 0.003). A key limitation of this clustered design clinical trial is the imbalance of some baseline characteristics. The control groups have a higher rate of baseline BZD prescription, and more GPs in the intervention group were women, GPs with a doctorate degree, and trainers of GP residents.ConclusionsA multicomponent intervention that targeted GPs and included educational meeting, feedback about BZD prescriptions, and a support web page led to a statistically significant reduction of BZD prescriptions and fewer long-term users. Although the effect size was small, the high prevalence of BZD use in the general population suggests that large-scale implementation of this intervention could have positive effects on the health of many patients.Trial registrationISRCTN ISRCTN28272199.

Project description:ImportanceMultidrug-resistant organisms (MDROs) can cause significant morbidity and mortality. Preventing MDROs can reduce the risk of subsequent transmission and infection.ObjectiveTo determine whether a multicomponent infection prevention intervention can reduce MDRO prevalence in nursing homes (NHs).Design, setting, and participantsThis cluster randomized clinical trial of a multicomponent intervention was conducted in 6 NHs in Michigan from September 2016 to August 2018. Three NHs adopted a multicomponent intervention, while 3 control NHs continued without investigator intervention. Study visits were conducted at baseline; days 7, 14, 21, and 30; and monthly thereafter for up to 6 months or discharge. Visits included clinical data collection and MDRO surveillance culturing of multiple body sites and high-touch surfaces in patient rooms. Any patients who provided informed consent within 14 days of admission to the NH were enrolled in this study. Non-English speakers and patients receiving hospice care were ineligible. Analysis was performed from November 2018 to February 2020.InterventionsIntervention NHs adopted a multicomponent intervention that included enhanced barrier precautions, chlorhexidine bathing, MDRO surveillance, environmental cleaning education and feedback, hand hygiene promotion, and health care worker education and feedback. Control nursing homes continued standard care practices.Main outcomes and measuresThe primary outcome, presence of MDROs, was measured longitudinally in the patient and room environment and was evaluated using generalized mixed effect models. The secondary outcome, time to new MDRO acquisition, was assessed using Cox proportional hazard models.ResultsA total of 6 NHs were included, with 245 patients (mean [SD] age, 72.5 [13.6] years; 134 [54.7%] women) enrolled; 3 NHs with 113 patients (46.1%) were randomized to the intervention group and 3 NHs with 132 patients (53.9%) were randomized to the control group. A total of 132 patients (53.9%) were White, and 235 patients (95.9%) were receiving postacute care. Over 808 study visits, 3654 patient cultures and 5606 environmental cultures were obtained. The intervention reduced the odds of MDRO prevalence in patients' environment by 43% (aOR, 0.57; 95% CI, 0.35-0.94), but there was no statistically significant difference on the patient level before or after adjustment (aOR, 0.57; 95% CI, 0.29-1.14). There were no significant reductions in time to new acquisition for methicillin-resistant Staphylococcus aureus (hazard ratio [HR], 0.20; 95% CI, 0.04-1.09), vancomycin-resistant enterococci (HR, 0.84; 95% CI, 0.46-1.53), or resistant gram-negative bacilli (HR, 1.14; 95% CI, 0.73-1.78).Conclusions and relevanceThis cluster randomized clinical trial found that the multicomponent intervention reduced the prevalence of MDROs in the environment of NH patients. Our findings highlight the potential for multicomponent interventions to directly and indirectly reduce MDRO prevalence in NHs.Trial registrationClinicalTrials.gov Identifier: NCT02909946.

Project description:IntroductionStroke is the leading cause of death and disability in China. The median time of stroke pre-hospital delay is more than 15 hours, mainly due to the lack of awareness on stroke symptoms and calling emergency services. We developed Stroke 1-2-0 recognition tool in China, by adapting Face, Arm, Speech and Time. Our preliminary findings suggested that Stroke 1-2-0 can improve public's knowledge of the stroke symptoms, but its impact on the prehospital delay is still unclear. Furthermore, these findings were mainly obtained from Shanghai, one of the largest metropolises in China. However, more than half of population in China lives in the rural area. Given the striking disparities in socioeconomic status and quality of stroke care across the nation, a multicentre trial is warranted.Methods and analysisStroke 1-2-0 education programme will adopt a multicentre, cluster-randomised controlled design. We aimed to recruit 32 communities from 16 counties across China. Each county includes two communities having more than 100 000 residents. The two communities sampled in the same county will be randomly assigned to receive either Stroke 1-2-0 education programme or usual care. The primary objective of this study is to evaluate the impact of Stroke 1-2-0 public education programme in reducing stroke prehospital delay among adults residing in the community, compared with the usual care. The intervention will be implemented for 1 year. The primary outcomes are the symptom onset to hospital arrival time ('onset-to-door time', ODT) and 3-hour hospital arriving rate. We will use an intention-to-treat approach. A linear mixed model will be used to control for potential cluster effects.Ethics and disseminationThis study is approved by the Shanghai Minhang District Central Hospital Institutional Review Board (Shanghai, China). The findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberChiCTR2000040782.

Project description:Background Stroke is one of the leading causes of disability-adjusted life years and may be the leading cause of death in rural regions in India. We aim to train the ASHAs (Accredited Social Health activist) for nonpharmacological management of risk factors for secondary stroke prevention in rural India. We tested the hypothesis that focused, multicomponent, short-term training on secondary prevention of stroke enhances the knowledge of ASHAs about risk factor management. Objectives To test the hypothesis that focused, multicomponent, short-term training on secondary prevention of stroke enhances the knowledge of ASHAs about risk factor management. Materials and Methods This study is part of the ASSIST trial (Training ASHA to Assist in Secondary Stroke Prevention in Rural Population). The study design is quasi-experimental (pretest and posttest). Culturally appropriate and pragmatic training material was developed by the study team. Three focused group training sessions were conducted in Sidhwan Bet and Pakhowal blocks of Ludhiana district, Punjab. Results A total of 274 ASHAs from 164 villages with mean ± SD age of 39.5 ± 7.6 years participated in the three training sessions. The perceived knowledge of stroke risk factors and blood pressure assessment was 67.5 ± 18.3% and 84.4 ± 16.7%, respectively. The objective baseline knowledge about stroke prevention and management among ASHAs was lower 58.7 ± 19.7% compared with perceived knowledge ( p = 0.04). This increased to 82.5 ± 16.36% ( p < 0.001) after the mop-up training after a mean of 191 days. More than 30% increment was seen in knowledge about the stroke symptoms (35.9%, p < 0.001), avoiding opium after stroke for treatment (39.5%, p < 0.001), causes of stroke (53.3%, p < 0.001), modifiable risk factors for stroke (45.4%, p < 0.001), and lifestyle modifications for stroke prevention (42.1%, p < 0.001). Conclusions Focused group training can help enhance the knowledge of ASHAs about stroke prevention and management. ASHAs are also able to retain this complex multicomponent knowledge over a 6-month period. ASHA may be able to partake in reducing the secondary stroke burden in rural India.

Project description:In 2011, more than half of the patients with stroke in Australian hospitals were not assessed for the need for rehabilitation. Further, there were no recommended criteria to guide rehabilitation assessment decisions. Subsequently, a decision-making tool called the Assessment for Rehabilitation Tool (ART) was developed. The ART was designed to assist Australian hospital clinicians to identify the rehabilitation needs of patients with stroke using evidence-based criteria. The ART was released and made freely available for use in 2012. This study evaluated the effectiveness of an education-only intervention (1 onsite education session and distribution of the ART) and a multifaceted intervention (2 or more onsite education sessions, distribution of the ART, audit and feedback, barrier identification, site-specific strategy development, promotion of interdisciplinary teamwork, opinion leaders and reminders) for improving assessments of rehabilitation needs after stroke.Ten hospitals in 2 states of Australia were randomly assigned to an education-only or a multifaceted intervention. Medical records were audited by assessors blinded to group allocation before and after the implementation period. Difference in the proportion of patients assessed for rehabilitation before and after the intervention was analysed using mixed-effects logistic regression analysis, with time period as the dependent variable, an interaction between intervention type and time included to test for differences between the interventions, and hospital included as the random effect to account for patient clustering.Data from 586 patients (284 pre-intervention; 302 post-intervention; age 76 years, 59 % male) showed that the multifaceted intervention was not more effective than education-only in improving the proportion of patients whose rehabilitation needs were assessed (reference category education-only; odds ratio 1.29, 95 % confidence interval 0.63-2.67, p = 0.483). Post-intervention, the odds of a patient's rehabilitation needs being assessed was 3.69 times greater than pre-intervention (95 % confidence interval 2.57-5.30, p < 0.001). Evidence-based criteria were not consistently used when patients were deemed to have no rehabilitation needs.A multifaceted intervention was not more effective than education-only in improving the assessment of rehabilitation needs of patients with stroke. Further interventions are required to ensure that all patients are assessed for the need for rehabilitation using evidence-based criteria.ANZCTR (Australian New Zealand Clinical Trials Registry), ACTRN12616000340437.

Project description:ObjectivesTo test the efficacy of a multicomponent technology intervention for reducing daily sedentary time and improving cardiometabolic disease risk among sedentary, overweight university employees.DesignBlinded, randomised controlled trial.SettingA large south-eastern university in the USA.Participants49 middle-aged, primarily female, sedentary and overweight adults working in sedentary jobs enrolled in the study. A total of 40 participants completed the study.InterventionsParticipants were randomised to either: (1) an intervention group (N=23; 47.6+9.9 years; 94.1% female; 33.2+4.5 kg/m(2)); (2) or wait-list control group (N=17; 42.6+8.9 years; 86.9% female; 31.7+4.9 kg/m(2)). The intervention group received a theory-based, internet-delivered programme, a portable pedal machine at work and a pedometer for 12 weeks. The wait-list control group maintained their behaviours for 12 weeks.Outcome measuresPrimary (sedentary and physical activity behaviour measured objectively through StepWatch) and secondary (heart rate, blood pressure, height, weight, waist circumference, per cent body fat, cardiorespiratory fitness, fasting lipids) outcomes were measured at baseline and postintervention (12 weeks). Exploratory outcomes including intervention compliance and process evaluation measures were also assessed postintervention.ResultsCompared to controls, the intervention group reduced daily sedentary time (mean change (95%CI): -58.7 min/day (-118.4 to 0.99; p<0.01)) after adjusting for baseline values and monitor wear time. Intervention participants logged on to the website 71.3% of all intervention days, used the pedal machine 37.7% of all working intervention days and pedalled an average of 31.1 min/day.ConclusionsThese findings suggest that the intervention was engaging and resulted in reductions in daily sedentary time among full-time sedentary employees. These findings hold public health significance due to the growing number of sedentary jobs and the potential of these technologies in large-scale worksite programmes.Trial registrationClinicalTrials.gov #NCT01371084.

Dataset Information

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

Publications

A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.

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