scholarly journals Tackling frailty at primary care: evaluation of the effectiveness of a multicomponent intervention through a randomised controlled trial: study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034591
Author(s):  
Francisco Rivas-Ruiz ◽  
Mónica Machón ◽  
Maider Mateo-Abad ◽  
Eugenio Contreras-Fernández ◽  
Carolina Güell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Functional Capacity ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Scientific Journal ◽  
Controlled Clinical Trial ◽  
Multifactorial Intervention ◽  
Randomised Controlled

IntroductionThis project focuses on how frailty is addressed in primary healthcare (PHC) and will evaluate the effectiveness of a multifactorial intervention (considering the appropriateness of the pharmaceutical prescription, the nutritional care provided and the exercise intervention) for persons with frailty, in terms of improving their functional capacity and reducing the incidence of adverse events related to frailty. The final evaluation will be made at 12 months’ follow-up.Methods and analysisPragmatic multicentre cluster randomised controlled clinical trial, single blind with two arms: multifactorial intervention in PHC versus usual follow-up. The randomisation unit is the patient list and the analysis unit is the patient. In addition, a cost-effectiveness study and a qualitative study will be carried out, the latter based on semistructured interviews and focus groups. Two hundred persons (100 per study branch) all aged ≥70 years, presenting frailty, but functionally independent and resident in the community, will be recruited. A baseline evaluation will be carried out prior to the intervention, with follow-up at 6 and 12 months. The main study variables considered will be functional capacity and incidence of adverse events; the secondary variables considered will be the patients’ sociodemographic characteristics, nutritional status, level of physical activity and drug consumption, together with data on comorbidity, cognitive and affective status and health-related quality of life. Data will be analysed according to the intention-to-treat principle using a 5% significance level.Ethics and disseminationThe study will at all times be conducted in strict accordance with the provisions of the Declaration of Helsinki and with the national legislation regulating patients’ autonomy. All patients recruited will be asked to provide written informed consent before taking part in the clinical trial. On completion of the study, the principal investigator expects to publish the results of this research in a peer-reviewed open access scientific journal.Trial registration numberISRCTN17143761.

scholarly journals Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Xie Xiaoyan ◽  
Danghan Xu ◽  
Lixing Zhuang ◽  
Hui Liu ◽  
Sui Tan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bronchial Asthma ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Blood Analysis ◽  
Quality Data ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Asthma Control Test

Abstract Background Bronchial asthma (BA) is one of the most common inflammatory airway disorders. As one of the main non-drug therapies, the Sanfu herbal patch (SHP) has been widely used to treat BA, although the evidence and mechanism are inconclusive. The objective of this pilot trial is to clarify the clinical efficacy and safety of the SHP in the treatment of BA in the chronic persistent or clinical remission stage and to provide high-quality data for further research.Methods: We propose a multicenter, double-blinded, parallel, randomized, placebo-controlled clinical trial involving 4 study hospitals in China. A total of 72 eligible participants will be randomized into an SHP group and a placebo group. They will receive SHP for 3 treatment sessions(TSs). The primary outcome will be changes in forced expiratory volume in one second after 3 TSs. Secondary outcomes will include: (1) the Asthma Quality of Life Questionnaire, Asthma Control Test, and Asthma Long-term Follow-up Scale; (2) levels of Metallothionein-2 and Transgelin-2 in blood and urine; and (3) levels of IL-5, IL-13, IL-23, IL-25, and thymic stromal lymphopoietin in blood. Analysis of the data will be performed at baseline, at the end of the 2nd and 3rd TSs and at 24-week follow-up. The safety of the SHP will be evaluated at each TS.Discussion: The aim of this trial is to determine whether SHP is more effective than placebo in the treatment of patients with BA, and whether SHP works by reducing airway inflammation and reversing bronchoconstriction.Trial registration: Chinese Clinical Trial Registry(http://www.chictr.org.cn), ChiCTR1900024616. Registered on 19 July 2019.

scholarly journals Gonadotropin-releasing hormone agonist versus expectant management for treating multiple leiomyomas after myomectomy: the study protocol for a multicentre, prospective, randomised controlled clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e044347
Author(s):  
Jia Wei ◽  
Xiangyi Ma ◽  
Wenwen Wang ◽  
Minli Zhang ◽  
Zhiying Yu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Expectant Management ◽  
Gonadotropin Releasing Hormone ◽  
Controlled Clinical Trial ◽  
Releasing Hormone ◽  
Gonadotropin Releasing Hormone Agonist ◽  
Pathological Result ◽  
Randomised Controlled

IntroductionLeiomyoma recurrence is a major concern for long-term myomectomy management, especially for multiple leiomyomas. Gonadotropin-releasing hormone agonist (GnRHa) is one of the most effective medications to reduce the volume of fibroids and the uterus. However, its role in preventing recurrence after conservative surgery remains unclear. At present, there is no randomised clinical trial determining the efficacy of GnRHa treatment for preventing multiple leiomyomas recurrence after myomectomy.Methods and analysisWe are conducting a phase IV randomised controlled trial in women aged 18–45 undergoing myomectomy for multiple leiomyomas. After surgery, women whose pathological result confirms multiple leiomyomas are randomised in a 1:1 ratio into an observation or GnRHa group. The primary outcome is the recurrence of either clinical symptoms or fibroids on imaging. Patients will be assessed for adverse events during the follow-up.Ethics and disseminationThe study was approved by the Medical Ethics Committee of the Tongji Hospital Affiliated with the Tongji Medical College of Huazhong University of Science and Technology (TJ-IRB20180311) according to the submitted study protocol (V.1.0, 10 November 2017) and informed consent (V.1.0, 10 November 2017). The results will be presented at domestic and international conferences and published in peer-reviewed journals.Trial registration numberChiCTR-IPR-17012992.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Writing up your clinical trial report for a scientific journal: The REPORT trial guide for effective and transparent research reporting without spin

2021 ◽  
Author(s):  
Thomas Bandholm ◽  
Kristian Thorborg ◽  
Clare Louise Ardern ◽  
Robin Christensen ◽  
Marius Henriksen
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Controlled Trial ◽  
Scientific Journal ◽  
Trial Report ◽  
Research Reporting ◽  
First Choice ◽  
Randomised Controlled ◽  
Study Designs ◽  
Structure Choice

The REPORT guide is a “How to” guide to help you achieve effective and transparent clinical trial reporting. It is intended to supplement “first choice” reporting tools, such as CONSORT, by adding tacit knowledge about reporting topics we have struggled with as authors or see others struggle with as journal reviewers or editors. Focus is the randomised controlled trial, but the guide is useful for other study designs as well. Topics included in the REPORT guide cover reporting checklists, trial report structure, choice of title, writing style, trial registry and reporting consistency, spin or reporting bias, transparent data presentation (figures), open access considerations, data sharing, and much more. We hope you find it useful.Preprint (open access): https://doi.org/xxxxxxxxxxxxxxx

scholarly journals Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial

2019 ◽  
Vol 25 (3) ◽  
pp. 305-309 ◽  
Author(s):  
Robert Fahed ◽  
Tim E Darsaut ◽  
Charbel Mounayer ◽  
René Chapot ◽  
Michel Piotin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Arteriovenous Malformation ◽  
Arteriovenous Malformations ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Cerebral Arteriovenous Malformations ◽  
Clinical Trial Registration ◽  
Transarterial Embolisation ◽  
Randomised Controlled ◽  
Transvenous Approach

Background Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation. Methods The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored. Discussion The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870.

scholarly journals Impact of oral rehabilitation on the quality of life of partially dentate elders in a randomised controlled clinical trial: 2 year follow-up

PLoS ONE ◽  
2018 ◽  
Vol 13 (10) ◽  
pp. e0203349 ◽  
Author(s):  
Gerald McKenna ◽  
Patrick Finbarr Allen ◽  
Martina Hayes ◽  
Cristiane DaMata ◽  
Ciaran Moore ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Oral Rehabilitation ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
Partially Dentate

scholarly journals Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016937 ◽  
Author(s):  
Ting Li ◽  
Joyce Yeung ◽  
Jun Li ◽  
Yan Zhang ◽  
Teresa Melody ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hip Fracture ◽  
General Anaesthesia ◽  
Older Patients ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Hip Fracture Surgery ◽  
Randomised Controlled ◽  
Fracture Surgery

IntroductionPostoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery.Methods and analysisRAGA-delirium is a pragmatic, multicentre, prospective, parallel grouped, randomised controlled clinical trial comparing RA or GA for hip fracture surgery. A total of 1000 patients who are 65 years or over and who are having planned hip fracture surgery in nine clinical trial centres of China will be randomised in a 1:1 ratio to receive either anaesthesia for the surgery. The primary endpoint will be the incidence of POD at day 7. The secondary endpoints will be the subtype, severity and duration of delirium, postoperative acute pain score, incidence of other postoperative non-delirium complications, quality of life and cost-effective outcomes. Randomisation will be performed at the patient level using computer-generated assignment. Outcome assessors will be blinded from intervention assignment. Assessments will be conducted before surgery, intraoperatively, postoperatively, during the hospital stay, at 30-day, 6-month and 1-year postoperative intervals.Potential impact of studyThis study will provide clinical evidence with a more robust methodology to help anaesthetists in selecting appropriate anaesthesia for older patients with high risk for POD. At the era of increasing emphasis on delirium prevention, this trial has the potential to inform the future national guideline to reduce POD.Ethics and disseminationEthical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.Trial registration numberClinicalTrials.gov (NCT02213380); pre-results.

Sign in / Sign up

Export Citation Format

Share Document