scholarly journals Protocol of a 12-month multifactorial eHealth programme targeting balance, dual-tasking and mood to prevent falls in older people: the StandingTall+ randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e051085
Author(s):  
Kimberley S van Schooten ◽  
Michele L Callisaya ◽  
Bridianne O'Dea ◽  
Thomas Lung ◽  
Kaarin Anstey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Older People ◽  
Fall Risk ◽  
Fear Of Falling ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
Well Being ◽  
Cost Utility ◽  
Control Group ◽  
Randomised Controlled

IntroductionFalls have a multifactorial aetiology, which may limit the effectiveness of the common approach of exercise as the sole intervention strategy. Multifactorial interventions could be more effective in people at high risk of falling; however, the focus of such interventions has traditionally been quite narrow. This paper describes the design of a randomised controlled trial that will evaluate the effectiveness of an eHealth programme, which addresses cumulative effects of key fall-risk factors across the triad of physical, affective and cognitive functions on falls in older people.Methods and analysis518 older people aged 65 years and over with high fall risk, defined as having a history of falls in the past 6 months, self-reported fear of falling or being aged 80 years or over, will be recruited via local advertisements, newsletters and presentations, and randomised to an intervention or health education control group. The intervention comprises balance exercise, cognitive-motor exercise and cognitive–behavioural therapy, with their dosage based on participant’s baseline balance, executive function and mood. The primary outcome is the rate of falls in the 12 months after randomisation. Secondary outcomes at 6 and 12 months comprise programme adherence, healthcare use, physical activity, balance and mobility, cognitive function, psychological well-being, quality of life, health literacy and user experience and attitudes towards the programme. Data will be analysed following intention to treat to gauge real-world effectiveness. We will further determine complier averaged causal effects to correct for varying adherence and conduct economic analyses to gain insight into cost-effectiveness and cost–utility.Ethics and disseminationEthical approval was obtained from the University of New South Wales (UNSW) Human Research Ethics Committee in December 2017. Outcomes will be disseminated via peer-reviewed articles, conference presentations, community events and media releases.Trial registration numberACTRN12619000540112.

scholarly journals Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640)

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031290
Author(s):  
Erica Schytt ◽  
Anna Wahlberg ◽  
Amani Eltayb ◽  
Rhonda Small ◽  
Nataliia Tsekhmestruk ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
Ethical Review ◽  
Control Group ◽  
Migrant Women ◽  
Intrapartum Care ◽  
Community Based ◽  
Randomised Controlled

IntroductionMigrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden.Methods and analysisA randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women’s ratings of the intrapartum care experiences and postnatal well-being are assessed at 6–8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2).Trial registration numberNCT03461640; Pre-results.

scholarly journals A protocol for a multicentre, parallel-group, pragmatic randomised controlled trial to evaluate the NEVERMIND system in preventing and treating depression in patients with severe somatic conditions

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Vladimir Carli ◽  
Danuta Wasserman ◽  
Gergö Hadlaczky ◽  
Nuhamin Gebrewold Petros ◽  
Sara Carletto ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Physiological Data ◽  
Control Group ◽  
Evidence Based ◽  
Treatment As Usual ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Depressive symptoms are common in individuals suffering from severe somatic conditions. There is a lack of interventions and evidence-based interventions aiming to reduce depressive symptoms in patients with severe somatic conditions. The aim of the NEVERMIND project is to address these issues and provide evidence by testing the NEVERMIND system, designed to reduce and prevent depressive symptoms in comparison to treatment as usual. Methods The NEVERMIND study is a parallel-groups, pragmatic randomised controlled trial to assess the effectiveness of the NEVERMIND system in reducing depressive symptoms among individuals with severe somatic conditions. The NEVERMIND system comprises a smart shirt and a user interface, in the form of a mobile application. The system is a real-time decision support system, aiming to predict the severity and onset of depressive symptoms by modelling the well-being condition of patients based on physiological data, body movement, and the recurrence of social interactions. The study includes 330 patients who have a diagnosis of myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants are randomised in blocks of ten to either the NEVERMIND intervention or treatment as usual as the control group. Clinical interviews and structured questionnaires are administered at baseline, at 12 weeks, and 24 weeks to assess whether the NEVERMIND system is superior to treatment as usual. The endpoint of primary interest is Beck Depression Inventory II (BDI-II) at 12 weeks defined as (i) the severity of depressive symptoms as measured by the BDI-II. Secondary outcomes include prevention of the onset of depressive symptoms, changes in quality of life, perceived stigma, and self-efficacy. Discussion There is a lack of evidence-based interventions aiming to reduce and prevent depressive symptoms in patients with severe somatic conditions. If the NEVERMIND system is effective, it will provide healthcare systems with a novel and innovative method to attend to depressive symptoms in patients with severe somatic conditions. Trial registration DRKS00013391. Registered 23 November 2017.

scholarly journals Virtual reality for relatives of ICU patients to improve psychological sequelae: study protocol for a multicentre, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e049704
Author(s):  
Johan H Vlake ◽  
Jasper van Bommel ◽  
Evert-Jan Wils ◽  
Tim Korevaar ◽  
Merel E Hellemons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Virtual Reality ◽  
Intensive Care ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Icu Patients ◽  
Randomised Controlled

IntroductionIntensive care unit (ICU) admission of a relative might lead to psychological distress and complicated grief (post-intensive care syndrome–family; PICS-F). Evidence suggests that increased distress during ICU stay increases risk of PICS-F, resulting in difficulty returning to their normal lives after the ICU experience. Effective interventions to improve PICS-F are currently lacking. In the present trial, we hypothesised that information provision using ICU-specific Virtual Reality for Family members/relatives (ICU-VR-F) may improve understanding of the ICU and subsequently improve psychological well-being and quality of life in relatives of patients admitted to the ICU.Methods and analysisThis multicentre, clustered randomised controlled trial will be conducted from January to December 2021 in the mixed medical-surgical ICUs of four hospitals in Rotterdam, the Netherlands. We aim to include adult relatives of 160 ICU patients with an expected ICU length of stay over 72 hours. Participants will be randomised clustered per patient in a 1:1 ratio to either the intervention or control group. Participants allocated to the intervention group will receive ICU-VR-F, an information video that can be watched in VR, while the control group will receive usual care. Initiation of ICU-VR-F will be during their hospital visit unless participants cannot visit the hospital due to COVID-19 regulations, then VR can be watched digitally at home. The primary objective is to study the effect of ICU-VR-F on psychological well-being and quality of life up to 6 months after the patients’ ICU discharge. The secondary outcome is the degree of understanding of ICU treatment and ICU modalities.Ethics and disseminationThe Medical Ethics Committee of the Erasmus Medical Centre, Rotterdam, the Netherlands, approved the study and local approval was obtained from each participating centre (NL73670.078.20). Our findings will be disseminated by presentation of the results at (inter)national conferences and publication in scientific, peer-reviewed journals.Trial registration numberNetherlands Trial Register (TrialRegister.nl, NL9220).

scholarly journals Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e022514 ◽  
Author(s):  
Stanley Kam Chung Chan ◽  
Dexing Zhang ◽  
Susan M Bögels ◽  
Christian Shaunlyn Chan ◽  
Kelly Yee Ching Lai ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Parenting Styles ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Brain Regions ◽  
Control Group ◽  
Children With Adhd ◽  
Informed Consent Form ◽  
Randomised Controlled

IntroductionMindfulness is one of the potential alternative interventions for children with attention-deficit hyperactivity disorder (ADHD). Some evidence suggests that mindfulness is related to changes in brain regions associated with ADHD. The potential benefits of mindfulness on children with ADHD, as well as the feasibility of this intervention approach, are warranted through prior local and foreign studies. This study aims to evaluate the effect of mindfulness-based group intervention for children with ADHD and their respective parents through a robust research design.Methods and analysisThis study will adopt a randomised controlled trial design including 140 children aged 8–12 years with ADHD together with one of their parents (n=140). These families will be randomised into intervention group (n=70) who will be offered the MYmind programme delivered by trained healthcare professionals, and an active control group (n=70) who will be offered the CBT programme. The intervention includes 8 weekly 90 min group sessions for children with ADHD (aged 8–12 years) and their respective parents. The primary and secondary outcomes will include children’s attention, ADHD-related symptoms, behaviours, executive function and mindfulness levels measured by validated objective measures and parent’s reported instruments. Parents’ parental stress, parenting styles, ADHD related symptoms, well-being, rumination level and mindfulness levels will also be measured. Analysis is by intention to treat. The effects of intervention will be evaluated by comparing outcomes between the two arms, as well as comparing outcomes within subject through comparing measurements at baseline (T0), immediately after the 8 week intervention (T1) and at 3 (T2) and 6 (T3) months postintervention.Ethics and disseminationEthics approval has been granted by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC). Participants will be required to sign informed consent form from both parents and children. Findings will be reported in conferences and peer-reviewed publications in accordance with recommendations of Consolidated Standards of Reporting Trials.Trial registration numberChiCTR1800014741; Pre-results.

The effect of cooperative high-intensity interval training on creativity and emotional intelligence in secondary school: A randomised controlled trial

2017 ◽  
Vol 25 (2) ◽  
pp. 355-373 ◽  
Author(s):  
Alberto Ruiz-Ariza ◽  
Sara Suárez-Manzano ◽  
Sebastián López-Serrano ◽  
Emilio J Martínez-López
Keyword(s):  
Emotional Intelligence ◽  
Randomised Controlled Trial ◽  
High Intensity ◽  
Controlled Trial ◽  
Interval Training ◽  
Well Being ◽  
Control Group ◽  
High Intensity Interval Training ◽  
High Intensity Interval ◽  
Randomised Controlled

Evidence suggests that moderate physical activity (PA) positively relates to creativity and emotional intelligence (EI) in adolescents. However, it is unknown whether cooperative PA (physical exercises in pairs or small groups to enhance motivation, self-efficacy, and pro-social behaviours), performed over less time but at higher intensity, could have similar effects within a school setting. The aim was to analyse the effect of cooperative high-intensity interval training (C-HIIT) on creativity and EI in adolescents aged 12–16 years, and whether improvement effects are different according to weekly PA level. A randomised controlled trial was conducted with a control group (CG, n = 94), which did static stretching, and an experimental group (EG, n = 90), which performed C-HIIT. Both groups performed the activity during 16 minutes at the beginning of physical education (PE) classes. Creativity was assessed with one factor, and EI through four factors (well-being, self-control, emotionality, and sociability). Age and body mass index (BMI) were used as confounders. Both were measured twice (baseline and after 12 weeks). The EG increased well-being and sociability factors after the C-HIIT programme (both p < 0.001). More specifically, inactive adolescents in the EG showed significant improvements in comparison to the CG in creativity, well-being, and sociability ( p = 0.028, p < 0.001, and p < 0.003, respectively). However, we did not find changes among active adolescents. A programme of C-HIIT in PE is a novel strategy to improve creativity and EI, especially in physically inactive adolescents. Starting PE classes with 16 minutes of C-HIIT could be recommended, independently of other activities planned for the session.

scholarly journals Effects of a rehabilitation programme using patient-personalised exergame on fear and risk of falling in vulnerable older adults: Protocol of randomised controlled trial (Preprint)

2020 ◽  
Author(s):  
Nolwenn Lapierre ◽  
Nathavy Um Din ◽  
Manuella Igout ◽  
Joël Chevrier ◽  
Joël Belmin
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Fear Of Falling ◽  
Medical Condition ◽  
Controlled Trial ◽  
Intervention Group ◽  
Rehabilitation Programme ◽  
Control Group ◽  
Risk Of Falling ◽  
Randomised Controlled

BACKGROUND Older adults have a high risk of falling, which leads to severe health and psychological consequences and can induce fear of falling. Rehabilitation programmes using exergames to prevent falls are increasingly explored. Medimoov is a movement-based patient-personalised exergame for rehabilitation in older adults. A preliminary study showed that its use may influence functional ability and motivation. Most existing studies evaluating the use of exergames do not involve an appropriate control group and do not focus on patient-personalised exergames. OBJECTIVE Thus, this study aims to evaluate the effects of Medimoov on falling risk and fear of falling in older adults compared with standard psychomotor rehabilitation. METHODS This study is an open, randomised controlled trial in parallel groups with blind data collection for the evaluation criterion. Twenty-five older adults per group will be recruited. The selection criteria will be: 1) 65 years of age or older, 2) ability to answer a questionnaire, 3) ability to stand in a bipedal position for at least 1 minute, 4) a score 13 or greater on the Short Fall Efficacy Scale and 5) to be in stable medical condition. Patients will be randomly allocated to two groups, as follows: the intervention group have bi-weekly sessions with Medimoov, the control group will follow the usual rehabilitation programme (bi-weekly psychomotor therapy sessions). Evaluations will be made before the intervention, after 4 weeks of intervention, and at the end of the intervention (after 8 weeks) and will focus on (1) risk of fall, (2) fear of falling and (3) cognitive evaluations. Physical activity outside the session will also be assessed by actimetry. The outcome assessment will be performed according intention-to-treat analysis. RESULTS N/A CONCLUSIONS This study will allow us to evaluate the effect of psychomotor rehabilitation using the Medimoov exergame platform on the fear of falling and risk of falling. If the effects of the Medimoov-assisted rehabilitation programme are shown to be effective for preventing falls and alleviating fear of falling, this pilot study will be the basis for larger trials. CLINICALTRIAL ClinicalTrials registration number: NCT04134988 (2019/10/22) https://clinicaltrials.gov/ct2/show/NCT04134988.

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