scholarly journals A tailored approach towards informing relatives at risk of inherited cardiac conditions: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025660
Author(s):  
Lieke M van den Heuvel ◽  
Yvonne M Hoedemaekers ◽  
Annette F Baas ◽  
J Peter van Tintelen ◽  
Ellen M A Smets ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Genetic Counselling ◽  
Study Protocol ◽  
Controlled Trial ◽  
Total Sample ◽  
Control Group ◽  
Genetic Counsellor ◽  
Dna Testing ◽  
Tailored Approach ◽  
Randomised Controlled

IntroductionIn current practice, probands are asked to inform relatives about the possibility of predictive DNA testing when a pathogenic variant causing an inherited cardiac condition (ICC) is identified. Previous research on the uptake of genetic counselling and predictive DNA testing in relatives suggests that not all relatives are sufficiently informed. We developed a randomised controlled trial to evaluate the effectiveness of a tailored approach in which probands decide together with the genetic counsellor which relatives they inform themselves and which relatives they prefer to have informed by the genetic counsellor. Here, we present the study protocol of this randomised controlled trial.MethodsA multicentre randomised controlled trial with parallel-group design will be conducted in which an intervention group receiving the tailored approach will be compared with a control group receiving usual care. Adult probands diagnosed with an ICC in whom a likely pathogenic or pathogenic variant is identified will be randomly assigned to the intervention or control group (total sample: n=85 probands). Primary outcomes are uptake of genetic counselling and predictive DNA testing by relatives (total sample: n=340 relatives). Secondary outcomes are appreciation of the approach used and impact on familial and psychological functioning, which will be assessed using questionnaires. Relatives who attend genetic counselling will be asked to fill out a questionnaire as well.Ethics and disseminationEthical approval was obtained from the Medical Ethical Committee of the Amsterdam University Medical Centres (MEC 2017-145), the Netherlands. All participants will provide informed consent prior to participation in the study. Results of the study on primary and secondary outcome measures will be published in peer-reviewed journals.Trial registration numberNTR6657; Pre-results.

scholarly journals Evaluating a custom-designed aid to improve communication of genetic results in families with hypertrophic cardiomyopathy: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e026627
Author(s):  
Charlotte Burns ◽  
Laura Yeates ◽  
Christopher Semsarian ◽  
Jodie Ingles
Keyword(s):  
At Risk ◽  
Hypertrophic Cardiomyopathy ◽  
Randomised Controlled Trial ◽  
Genetic Counselling ◽  
Study Protocol ◽  
Controlled Trial ◽  
Genetic Counsellor ◽  
Communication Aid ◽  
Randomised Controlled ◽  
Genetic Results

IntroductionGenetic testing for hypertrophic cardiomyopathy (HCM) in the era of genomics brings unique challenges for genetic counselling. The number of genes routinely included in an HCM gene panel has increased markedly, many with minimal if any robust evidence of gene–disease association. Subsequently, there is a greater chance of uncertain genetic findings. The responsibility of communicating this information with at-risk relatives lies with the index case (proband). We have developed a communication aid to assist with the delivery of genetic results to the proband. We have previously shown the aid is feasible and acceptable and have now developed a study protocol for a randomised controlled trial of a genetic counsellor-led intervention incorporating the communication aid.Methods and analysisThis is a prospective randomised controlled trial. We will investigate the impact of a genetic counsellor-led intervention to return proband genetic results using a custom-designed communication aid. We aim to improve knowledge and empowerment. The primary outcome of this trial is the ability and confidence of the proband to communicate genetic results to at-risk relatives. Secondary outcomes will assess genetic knowledge, satisfaction with services, outcomes from genetic counselling and psychological adaptation to genetic information.Ethics and disseminationThis study has been approved by and is in strict accordance with the Sydney Local Health District Ethics Review Committee (X16-0030; 22/01/2016; version 1). Results from this trial will be prepared as a manuscript and submitted to peer-reviewed journals for publication as well as submission for presentation at national and international meetings.Trial registration numberACTRN12617000706370.

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 Mindfulness-based and cognitive-based stress prevention in student teachers (startklar): study protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e021941
Author(s):  
Jasmina Eskic ◽  
Sophie Merle Kuhlmann ◽  
Katharina Kreinbihl ◽  
Florian Hammerle
Keyword(s):  
Randomised Controlled Trial ◽  
Student Teachers ◽  
Study Protocol ◽  
Controlled Trial ◽  
Control Group ◽  
High Risk Population ◽  
Stress Prevention ◽  
Positive Effects ◽  
Randomised Controlled

IntroductionTeachers and student teachers in Germany are a high-risk population for stress and stress-related mental health problems. This often leads to early retirement in subsequent professional life. Various trials have demonstrated positive effects of stress prevention training on the perceived stress and stress-related symptoms of teachers. Although many studies show positive effects of mindfulness-based stress interventions, there is not yet any mindfulness-based intervention for teachers or student teachers in Germany. The aim of this trial is to evaluate a training that combines mindfulness-based and cognitive interventions into one programme, addressing to the specific burdens of student teachers.Methods and analysisThis study protocol presents a prospective block-randomised controlled trial. Assessment will take place at three time points (baseline, post-intervention, 3-month follow-up) for an intervention and waiting control group, and at a fourth assessment point for the waiting control group after receiving the training. The aim is to evaluate the effects of mindfulness-based stress prevention on stress, psychological morbidity, burnout and self-efficacy using validated measures. Participants are student teachers from German teacher training colleges and participation will be voluntary. The targeted total sample size is 96 at 3-month follow-up. The training will comprise three 4-hour sessions conducted every 2 weeks. The control group will participate in the training after the 3-month follow-up. The allotment will be randomised with a stratified allocation ratio by gender. After descriptive statistics have been evaluated, inferential statistical analysis will be conducted using repeated measures analysis of variance with interactions between time and group. Effect sizes will be calculated using partial η2values.Ethics and disseminationResults will be disseminated at conferences, in specialist magazines and through peer-reviewed publications. The trial has been approved by the ethics review board of the local medical association, Mainz, Germany, under the reference number 837.192.16 (10511).Trial registration numberDRKS00010897.

scholarly journals Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ananda Sidarta ◽  
Yu Chin Lim ◽  
Christopher Wee Keong Kuah ◽  
Yong Joo Loh ◽  
Wei Tech Ang
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Upper Limb ◽  
Controlled Trial ◽  
Chronic Stroke ◽  
Community Dwelling ◽  
Control Group ◽  
Stroke Survivors ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Prior studies have established that senses of the limb position in space (proprioception and kinaesthesia) are important for motor control and learning. Although nearly one-half of stroke patients have impairment in the ability to sense their movements, somatosensory retraining focusing on proprioception and kinaesthesia is often overlooked. Interventions that simultaneously target motor and somatosensory components are thought to be useful for relearning somatosensory functions while increasing mobility of the affected limb. For over a decade, robotic technology has been incorporated in stroke rehabilitation for more controlled therapy intensity, duration, and frequency. This pilot randomised controlled trial introduces a compact robotic-based upper-limb reaching task that retrains proprioception and kinaesthesia concurrently. Methods Thirty first-ever chronic stroke survivors (> 6-month post-stroke) will be randomly assigned to either a treatment or a control group. Over a 5-week period, the treatment group will receive 15 training sessions for about an hour per session. Robot-generated haptic guidance will be provided along the movement path as somatosensory cues while moving. Audio-visual feedback will appear following every successful movement as a reward. For the same duration, the control group will complete similar robotic training but without the vision occluded and robot-generated cues. Baseline, post-day 1, and post-day 30 assessments will be performed, where the last two sessions will be conducted after the last training session. Robotic-based performance indices and clinical assessments of upper limb functions after stroke will be used to acquire primary and secondary outcome measures respectively. This work will provide insights into the feasibility of such robot-assisted training clinically. Discussion The current work presents a study protocol to retrain upper-limb somatosensory and motor functions using robot-based rehabilitation for community-dwelling stroke survivors. The training promotes active use of the affected arm while at the same time enhances somatosensory input through augmented feedback. The outcomes of this study will provide preliminary data and help inform the clinicians on the feasibility and practicality of the proposed exercise. Trial registration ClinicalTrials.gov NCT04490655. Registered 29 July 2020.

scholarly journals Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e033844
Author(s):  
Kamilya Jamel Baljon ◽  
Muhammad Hibatullah Romli ◽  
Adibah Hanim Ismail ◽  
Lee Khuan ◽  
Boon How Chew
Keyword(s):  
Saudi Arabia ◽  
Randomised Controlled Trial ◽  
Sample Size ◽  
Study Protocol ◽  
Human Subjects ◽  
Controlled Trial ◽  
Labour Pain ◽  
Control Group ◽  
Breathing Exercises ◽  
Randomised Controlled

IntroductionLabour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae.Methods and analysisThis randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26–34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.Ethics and disseminationEthical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019–169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.Trial registration numberISRCTN87414969, registered 3 May 2019.

scholarly journals Cognitive–behavioural group therapy for adolescents with ADHD: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e032839 ◽  
Author(s):  
Torunn Stene Nøvik ◽  
Anne-Lise Juul Haugan ◽  
Stian Lydersen ◽  
Per Hove Thomsen ◽  
Susan Young ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Group Therapy ◽  
Study Protocol ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Treatment As Usual ◽  
Cognitive Behavioural ◽  
Child Psychiatric ◽  
Randomised Controlled

IntroductionPersistence of attention deficit hyperactivity disorder (ADHD) into adolescence is a significant burden to patients. Clinical guidelines recommend non-pharmacological therapies, but the evidence to support this recommendation is sparse. This study aims to evaluate the effect of a 12-week group cognitive–behavioural therapy (CBT) programme for adolescents with ADHD aged 14–18 years, who still have impairing symptoms after treatment with medication. We will study the effect of the treatment on ADHD symptoms and examine moderators and mediators of the effect of the treatment on ADHD.Methods and analysisWe conduct a randomised controlled trial of CBT group therapy in adolescents with ADHD recruited from child psychiatric outpatient units in Mid-Norway. 99 adolescents who met inclusion criteria and consented to participation have been randomised to a 12-week group intervention or to a control group receiving treatment as usual. Assessments are made at admission to the clinic, preintervention, postintervention and at a 9-month follow-up, obtaining adolescent, parent and teacher reports. Clinicians blinded to group allocation rate all participants as to their functioning preintervention and at the two postintervention assessment points. The primary outcome is change in symptom scores on the ADHD Rating Scale-IV.Ethics and disseminationThe Regional Committee for Medical and Health Research Ethics in South East Norway approved the study protocol (2015/2115). We will disseminate the findings in peer-reviewed publications and conference presentations, to user organisations and at courses attended by families and professionals. Two PhD students will publish and defend dissertations relating to the study. Planned publications include primary and secondary outcomes and patient satisfaction with the treatment. Furthermore, we plan to publish a manual of CBT group therapy in adolescent ADHD to benefit treatment of patients in Norway and elsewhere.Trial registration numberNCT02937142

scholarly journals Brief mindfulness-based intervention of ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’: a study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e041364
Author(s):  
Yanhui Liao ◽  
Ling Wang ◽  
Tao Luo ◽  
Shiyou Wu ◽  
Zhenzhen Wu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Psychological Traits ◽  
Study Results ◽  
Before And After ◽  
Randomised Controlled

IntroductionFace-touching behaviour often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behaviour disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’ in reducing face-touching behaviour.Methods and analysisThis will be an online-based, randomised, controlled, trial. We will recruit 1000 participants, and will randomise and allocate participants 1:1 to the ‘STOP touching your face’ (both 750-word text and 5 min audio description by online) intervention group (n=500) and the wait-list control group (n=500). All participants will be asked to monitor and record their face-touching behaviour during a 60 min period before and after the intervention. Primary outcome will be the efficacy of short-term mindfulness-based ‘STOP touching your face’ intervention for reducing the frequency of face-touching. The secondary outcomes will be percentage of participants touching their faces; the correlation between the psychological traits of mindfulness and face-touching behaviour; and the differences of face-touching behaviour between left-handers and right-handers. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson’s correlations will be applied in data analysis. We will recruit 1000 participants from April to July 2020 or until the recruitment process is complete. The follow-up will be completed in July 2020. We expect all trial results to be available by the end of July 2020.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (No. 20200401-32). Study results will be disseminated via social media and peer-reviewed publications.Trial registration numberNCT04330352.

scholarly journals Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048410
Author(s):  
Lu Wang ◽  
Lina Wu ◽  
Xuejun Li ◽  
Ying Zhang ◽  
Jing Lai ◽  
...  
Keyword(s):  
Treatment Group ◽  
Randomised Controlled Trial ◽  
Hepatitis B ◽  
Study Protocol ◽  
Controlled Trial ◽  
Hbv Dna ◽  
Alanine Transaminase ◽  
Control Group ◽  
Tenofovir Alafenamide ◽  
Randomised Controlled

IntroductionThe current clinical guidelines do not recommend antiviral therapy for subjects with positive hepatitis B virus (HBV)-DNA and normal alanine transaminase (ALT). In this study, we will assess the safety and efficacy of tenofovir alafenamide fumarate (TAF) in the treatment of adults with positive HBV-DNA and normal ALT, including long-term prognosis.Methods and analysisThis study is a non-double-blind randomised controlled trial. Study participants will be randomised into the treatment group and the control group. In the treatment group, subjects will receive TAF monotherapy, while those in the control group will receive no antiviral treatment. Subjects will be followed up at the beginning of the study and every 12 or 24 weeks thereafter for review of laboratory findings and to record adverse events. The primary endpoint is the proportion of patients with serum hepatitis B surface antigen loss.Ethics and disseminationThis study protocol was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University for Human Study (reference number [2019]02-599-01). The results of this study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04231565.

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

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