scholarly journals Proximal Femoral Nail Unlocked versus Locked (ProFNUL): a protocol for a multicentre, parallel-armed randomised controlled trial for the effect of femoral nail mode of lag screw locking and screw configuration in the treatment of intertrochanteric femur fractures

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e032640 ◽  
Author(s):  
Arjun Sivakumar ◽  
Dominic Thewlis ◽  
Andreas Ladurner ◽  
Suzanne Edwards ◽  
Mark Rickman
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Functional Independence ◽  
Local Health ◽  
Intertrochanteric Fractures ◽  
Management Options ◽  
Lag Screw ◽  
Femoral Nail ◽  
Surgical Data ◽  
Randomised Controlled

IntroductionIntertrochanteric fractures are common fragility injuries in the elderly. Surgical fixation using intramedullary devices are one of the widely used management options. To date, evidence demonstrating the effects of lag screw configuration and the mode of lag screw locking in these devices is lacking. The purpose of this study is to investigate whether the lag screw configuration (single vs integrated dual interlocking screw) and the mode of lag screw locking (static vs dynamic) of a femoral nail device result in differences in clinical and functional outcomes.Methods and analysisA multicentre, pragmatic, single-blinded randomised controlled trial (RCT) with a three-arm parallel group design is proposed. Nine-hundred patients with intertrochanteric fractures (A1 and A2 AO/OTA) will be randomised to fracture treatment using a Gamma3 nail (Stryker; proximally dynamic) or a Trigen Intertan nail (Smith & Nephew) in a dynamic or static lag screw configuration. The primary outcome measure consists of radiological evidence of construct failure within 6 months following surgery, with failure being defined as breakage of the femoral nail or distal locking screw, a change in tip-apex distance of more than 10 mm or lag screw cut-out through the femoral head. Secondary outcomes include surgical data (operation time, fluoroscopy time), complications (surgical site infection, reoperation, patient death), return to mobility and home circumstances, functional independence, function and pain. Patients who are able to walk independently with or without a mobility aid and are able to answer simple questions and follow instructions will be asked to participate in three dimensional gait analysis at 6 weeks and 6 months to assess hip biomechanics from this cohort. Additional secondary measures of gait speed, hip range of motion, joint contact and muscle forces and gross activity monitoring patterns will be obtained in this subgroup.Ethics and disseminationThe Central Adelaide Local Health Network Human Research Ethics Committee has approved the protocol for this RCT (HREC/17/RAH/433). The results will be disseminated via peer-reviewed publications and presentations at relevant conferences.Trial registration numberACTRN12618001431213.

scholarly journals Targeted, structured text messaging to improve dietary and lifestyle behaviours for people on maintenance haemodialysis (KIDNEYTEXT): study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023545 ◽  
Author(s):  
Jessica Stevenson ◽  
Katrina L Campbell ◽  
Mark Brown ◽  
Jonathan Craig ◽  
Kirsten Howard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Dietary Guidelines ◽  
Drop Out ◽  
Local Health ◽  
Lifestyle Behaviours ◽  
Randomised Controlled

IntroductionManaging nutrition is critical for reducing morbidity and mortality in patients on haemodialysis but adherence to the complex dietary restrictions remains problematic. Innovative interventions to enhance the delivery of nutritional care are needed. The aim of this phase II trial is to evaluate the feasibility and effectiveness of a targeted mobile phone text messaging system to improve dietary and lifestyle behaviours in patients on long-term haemodialysis.Methods and analysisSingle-blinded randomised controlled trial with 6 months of follow-up in 130 patients on haemodialysis who will be randomised to either standard care or KIDNEYTEXT. The KIDNEYTEXT intervention group will receive three text messages per week for 6 months. The text messages provide customised dietary information and advice based on renal dietary guidelines and general healthy eating dietary guidelines, and motivation and support to improve behaviours. The primary outcome is feasibility including recruitment rate, drop-out rate, adherence to renal dietary recommendations, participant satisfaction and a process evaluation using semistructured interviews with a subset of purposively sampled participants. Secondary and exploratory outcomes include a range of clinical and behavioural outcomes and a healthcare utilisation cost analysis will be undertaken.Ethics and disseminationThe study has been approved by the Western Sydney Local Health District Human Research Ethics Committee—Westmead. Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12617001084370; Pre-results.

scholarly journals Study protocol for a randomised controlled trial investigating two different refeeding formulations to improve safety and efficacy of hospital management of adolescent and young adults admitted with anorexia nervosa

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038242
Author(s):  
Elizabeth Parker ◽  
Victoria Flood ◽  
Mark Halaki ◽  
Christine Wearne ◽  
Gail Anderson ◽  
...  
Keyword(s):  
Young Adults ◽  
Anorexia Nervosa ◽  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Enteral Feeding ◽  
Controlled Trial ◽  
Local Health ◽  
Adolescent And Young Adults ◽  
Enteral Formula ◽  
Randomised Controlled

IntroductionProviding effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An ‘underfeeding syndrome’ can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15–25 years), hospitalised with AN.Methods and analysisThe study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.Ethics and disseminationThe protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.

scholarly journals Matching depression management to severity prognosis in primary care: results of the Target-D randomised controlled trial

2020 ◽  
pp. BJGP.2020.0783
Author(s):  
Susan Fletcher ◽  
Patty Chondros ◽  
Konstancja Densley ◽  
Elizabeth Murray ◽  
Christopher Dowrick ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Symptom Severity ◽  
Controlled Trial ◽  
Psychological Therapy ◽  
Management Options ◽  
Waiting Room ◽  
Serious Adverse Events ◽  
Randomised Controlled

BackgroundMental health treatment rates are increasing, but the burden of disease has not reduced. Tools to support efficient resource distribution are required.AimTo investigate whether a person-centred e-health (Target-D) platform matching depression care to symptom severity prognosis can improve depressive symptoms relative to usual care.Design and settingStratified individually randomised controlled trial in 14 general practices in Melbourne, Australia, from April 2016 to February 2019. In total, 1868 participants aged 18–65 years who had current depressive symptoms; internet access; no recent change to antidepressant; no current antipsychotic medication; and no current psychological therapy were randomised (1:1) via computer-generated allocation to intervention or usual care.MethodThe intervention was an e-health platform accessed in the GP waiting room, comprising symptom feedback, priority-setting, and prognosis-matched management options (online self-help, online guided psychological therapy, or nurse-led collaborative care). Management options were flexible, neither participants nor staff were blinded, and there were no substantive protocol deviations. The primary outcome was depressive symptom severity (9-item Patient Health Questionnaire [PHQ-9]) at 3 months.ResultsIn intention to treat analysis, estimated between- arm difference in mean PHQ-9 scores at 3 months was −0.88 (95% confidence interval [CI] = −1.45 to −0.31) favouring the intervention, and −0.59 at 12 months (95% CI = −1.18 to 0.01); standardised effect sizes of −0.16 (95% CI = −0.26 to −0.05) and −0.10 (95% CI = −0.21 to 0.002), respectively. No serious adverse events were reported.ConclusionMatching management to prognosis using a person-centred e-health platform improves depressive symptoms at 3 months compared to usual care and could feasibly be implemented at scale. Scope exists to enhance the uptake of management options.

scholarly journals ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023863
Author(s):  
Julie Redfern ◽  
Karice Hyun ◽  
Anna Singleton ◽  
Nashid Hafiz ◽  
Rebecca Raeside ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Respiratory Disease ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Message ◽  
Chronic Respiratory Disease ◽  
Control Group ◽  
Local Health ◽  
Support Programme ◽  
Randomised Controlled

IntroductionSimple and scalable strategies are needed to improve ‘out-of-hospital’ support and management for people living with cardiovascular disease (CVD) and respiratory disease. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change and is supported by quantitative and qualitative evidence. The aim of this study is to test the effectiveness and implementation of a 6-month text messaging support programme for people with CVD and respiratory disease as an addition to cardiac and pulmonary outpatient rehabilitation.Methods and analysisPragmatic randomised controlled trial (n=310) to test the effectiveness of a 6-month text message support programme on clinical outcomes in people with CVD and chronic respiratory disease who are attending outpatient cardiac and pulmonary rehabilitation. The study includes a nested process evaluation to inform scalability and implementation across settings. The intervention group will receive a text message support programme comprising five messages per week for 26 weeks and the control group will continue with standard care. The primary outcome is exercise capacity (6 min walk distance). Secondary outcomes include clinical measures (proportion of people meeting the Australian guideline-recommended blood pressure and cholesterol targets), lifestyle outcomes (smoking rates, achievement of national guidelines for nutrition and physical activity), quality of life, mood (Hospital Anxiety and Depression Scale), medication adherence and attendance at and completion of rehabilitation.Ethics and disseminationPrimary ethics approval was received from the Sydney Local Health District Hospital Human Research Ethics Committee and associated Governance committees at sites. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. At its conclusion, the study will determine the effectiveness and implementation of a simple programme that aims to improve health outcomes and attendance at rehabilitation for people with CVD and chronic respiratory disease.Trial registration numberACTRN12616001167459

scholarly journals "More Air – Better Performance – Faster Recovery": Study Protocol for Randomised Controlled Trial of the Effect of Post-stroke Inspiratory Muscle Training for Adults

2021 ◽  
Author(s):  
Susanne Lillelund Sørensen ◽  
Simon Svanborg Kjeldsen ◽  
Sine Secher Mortensen ◽  
Ulla Torp Hansen ◽  
Dorthe Hansen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Activities Of Daily Living ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Functional Independence ◽  
Inspiratory Muscle ◽  
Inspiratory Muscle Training ◽  
Muscle Training ◽  
Randomised Controlled

Abstract Background: Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among others, decreased respiratory muscle function, decreased ability to expand the thorax and postural dysfunction. These deficits affect the patient's ability to perform daily activities, produce fatigue and reduce endurance and quality of life. Inspiratory muscle training (IMT) aims to improve the strength and endurance of the diaphragm and the external intercostal muscles. The objective of this study was to investigate i) the effect of three weeks of IMT on maximal inspiratory pressure (MIP) in adults having suffered a stroke, and ii) the effects of three weeks of IMT on the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance and expiratory function.Methods/Design: This is a randomised controlled trial (RCT) comparing IMT with conventional neurorehabilitation (usual practise). The trial will include 80 patients with reduced MIP hospitalised at a specialised neurorehabilitation hospital in Denmark. The intervention group will receive IMT sessions, exercising at 30% of MIP. Patients in the intervention group will perform two daily sessions (one session of IMT with Threshold IMT consisting of two times 15 inspirations at normal breathing rhythm (5-10 min)), seven days a week for three weeks. Training can be with or without physiotherapist supervision. Study outcomes: MIP assessed by the Power Breath, Functional Independence Measurement, The 6-minute Walk Test, the Fatigue Severity Scale and average voice volume. Expiratory function will be assessed using spirometry. All assessments will be conducted at baseline and three weeks (at termination of the intervention) and three months after the intervention has concluded.Discussion: The primary purpose of this study is to assess the effect of IMT interventions in patients with reduced MIP following stroke; secondarily, to assess the effect of IMT on the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance and expiratory capacity. Hereby, this study accepts the call for further research.Trial registration: ClinicalTrials.gov NCT04686019. Registered 28.12.2020, https://www.clinicaltrials.gov/ct2/show/NCT04686019

scholarly journals Protocol for a randomised controlled trial of continuous infusions of vancomycin to improve the attainment of target vancomycin levels in young infants: The VANC trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e022603
Author(s):  
Amanda Gwee ◽  
Noel Cranswick ◽  
Susan M Donath ◽  
Rodney Hunt ◽  
Nigel Curtis
Keyword(s):  
Steady State ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Target Range ◽  
Full Blood Count ◽  
Attractive Alternative ◽  
Local Health ◽  
Mixed Effect ◽  
Young Infants ◽  
Randomised Controlled

IntroductionVancomycin is frequently used in the treatment of late-onset sepsis in young infants and is routinely administered as intermittent infusions (IIV); however, existing IIV dosing guidelines achieve target vancomycin levels in less than half of infants. Continuous infusions of vancomycin (CIV) are an attractive alternative as adult studies report a higher attainment of target vancomycin levels, simpler drug monitoring and fewer drug side effects.MethodsThis is a multicentre, randomised controlled trial in which 200 young infants (aged 0–90 days) requiring vancomycin will be randomised to CIV or IIV for a duration determined by the treating clinician. Vancomycin levels will be measured immediately after the first dose in both arms. Trough and peak levels will be determined in the IIV arm and steady-state levels 18–30 hours after commencement of infusion will be measured in the CIV arm. Full blood count, urea and electrolytes, and C reactive protein level will be monitored throughout treatment. For all Gram-positive bacteria isolated from blood culture, a vancomycin Etest will be done to determine the minimum inhibitory concentration of the bacterium.AnalysisPrimary outcome: the proportion of infants with levels within target range at their first steady-state concentration. Secondary outcomes: (1) the proportion of drug-related adverse effects; (2) the time to achieve target levels in the blood; (3) the pharmacodynamics of vancomycin (using non-linear mixed effect modelling).Ethics and disseminationThe study has been approved by The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC) (No. 34030) and the South Eastern Sydney Local Health District HREC (SSA 16/G/335). Results will be published in a peer-reviewed journal.Trial registration numberNCT02210169.

scholarly journals Design and rationale of the MyHeartMate study: a randomised controlled trial of a game-based app to promote behaviour change in patients with cardiovascular disease

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024269 ◽  
Author(s):  
Robyn Gallagher ◽  
Clara Chow ◽  
Helen Parker ◽  
Lis Neubeck ◽  
David Celermajer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary Prevention ◽  
Behaviour Change ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Mobile App ◽  
Lifestyle Changes ◽  
Local Health ◽  
Randomised Controlled ◽  
The Impact

IntroductionRecurrence of cardiac events is common after a first event, leading to hospitalisations and increased health burden. Patients have difficulties achieving the lifestyle changes required for secondary prevention and access to secondary prevention programs is limited. This study aims to evaluate the impact of a game-based mobile app, MyHeartMate, which is designed to motivate engagement in secondary prevention behaviours for cardiovascular risk factors.Methods and analysisThe MyHeartMate study is a randomised controlled trial with 6-month follow-up and blinded assessment of the primary outcome. Participants (n=394) with coronary heart disease will be recruited from hospitals in metropolitan Sydney and randomly allocated to standard care or the MyHeartMate app intervention. The intervention group will receive the app, which uses game techniques to promote engagement and lifestyle behaviour change for secondary prevention. The primary outcome is difference between the groups in physical activity (metabolic equivalent of task minutes/week) at 6 months. Secondary outcomes include change in low-density lipoprotein cholesterol, systolic blood pressure, medication adherence, body mass index, waist circumference, mood and dietary changes at 6 months. Data on app engagement, and patient perspectives of usability and acceptability, will also be analysed.Ethics and disseminationThe study has received ethics approval from Northern Sydney Local Health District Human Research Ethics Committee. The study findings will be disseminated via peer-reviewed publications and presentation at international scientific meetings/conferences.Trial registration numberACTRN12617000869370; Pre-results.

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