scholarly journals Cluster-randomised controlled trial of Stroke 1-2-0 education programme to reduce stroke prehospital delay in China: a study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e048064
Author(s):  
Yong Wang ◽  
Yang Liu ◽  
Renyu Liu ◽  
Jing Zhao
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Education Programme ◽  
Primary Objective ◽  
Prehospital Delay ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

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.

scholarly journals Combined effect of pill refilling and self-medication reminder system on patients’ adherence to tuberculosis treatment during continuation phase in Northwest Ethiopia: a study protocol for randomised controlled trial

2019 ◽  
Vol 26 (1) ◽  
pp. e100050
Author(s):  
Kassahun Dessie Gashu ◽  
Kassahun Alemu Gelaye ◽  
Richard Lester ◽  
Binyam Tilahun
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Treatment Phase ◽  
Tb Treatment ◽  
Generalised Linear Mixed Model ◽  
Continuation Treatment ◽  
Randomised Controlled

IntroductionPatients’ failure to adhere on tuberculosis (TB) treatment leads to drug resistance, relapse and death. Non-adherence to TB treatment is higher during continuation treatment phase. The study aimed to evaluate effectiveness of combined pill refilling and medication reminders on adherence to TB treatment.Methods and analysisA two-arm randomised controlled trial on adult patients with TB was used during continuation treatment phase. In the first arm, in addition to usual care, participants will receive cellphone-based daily medication and weekly pill refilling reminders. In the control arm, participants will receive only usual care. The study will use a covariate adaptive randomisation technique to balance covariates during allocation. The primary outcome is patients’ adherence to TB treatment and secondary outcomes are attendance to clinic and treatment outcomes. We apply intention to treat with generalised linear mixed model.Ethics and disseminationEthical approval was obtained from Institutional Review Board of University of Gondar. Written informed consent was applied during enrolment. We will publish findings in peer-reviewed, scientific journals and conferences.Trial registration numberPACTR201901552202539.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals The Use of Telehealth Technology in Assessing the Accuracy of Self-Reported Weight and the Impact of a Daily Immediate-Feedback Intervention among Obese Employees

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Nicolaas P. Pronk ◽  
A. Lauren Crain ◽  
Jeffrey J. VanWormer ◽  
Brian C. Martinson ◽  
Jackie L. Boucher ◽  
...  
Keyword(s):  
Body Weight ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Groups ◽  
Outcome Variable ◽  
Control Group ◽  
Immediate Feedback ◽  
The Impact

Objective.To determine the accuracy of self-reported body weight prior to and following a weight loss intervention including daily self-weighing among obese employees.Methods.As part of a 6-month randomized controlled trial including a no-treatment control group, an intervention group received a series of coaching calls, daily self-weighing, and interactive telemonitoring. The primary outcome variable was the absolute discrepancy between self-reported and measured body weight at baseline and at 6 months. We used general linear mixed model regression to estimate changes and differences between study groups over time.Results.At baseline, study participants underreported their weight by an average of 2.06 (se=0.33) lbs. The intervention group self-reported a smaller absolute body weight discrepancy at followup than the control group.Conclusions.The discrepancy between self-reported and measured body weight appears to be relatively small, may be improved through daily self-monitoring using immediate-feedback telehealth technology, and negligibly impacts change in body weight.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

2019 ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Exercise Intervention ◽  
Randomised Trial ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
First Choice ◽  
Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

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