scholarly journals Metabolic Surgery Supporting Aftercare via Group-Intervention (MeSSAGES): study protocol of a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053839
Author(s):  
Eva-Maria Skoda ◽  
Jasmin Steinbach ◽  
Anita Robitzsch ◽  
Corinna Pfeiffer ◽  
Lynik Schüren ◽  
...  
Keyword(s):  
Social Media ◽  
Obesity Surgery ◽  
Metabolic Surgery ◽  
Self Efficacy ◽  
Group Intervention ◽  
Intervention Group ◽  
Controlled Study ◽  
Therapeutic Success ◽  
Subject Factor ◽  
Randomised Controlled

IntroductionObesity is a constantly rising and cost-intensive medical issue worldwide. Severe obesity often needs surgery to promote weight loss, but due to the rapid therapeutic success after the surgery, many patients lack the awareness of the need to consistently maintain the postoperative care. However, therapeutic success and psychological well-being can be increased through group interventions and social support of the group members. Therefore, aftercare via group intervention is a promising approach. In this prospective randomised controlled study, the self-efficacy in a social media-based interactive, psychoeducational intervention is to be tested.Methods and analysisThe intervention group will complete a social media-supported group intervention for 6 weeks with weekly postings of educative contents and the possibility to exchange in groups via anonymous avatars. The control group will receive treatment as usual (TAU) after the obesity surgery as recommended in the German S3-guidelines Obesity Surgery and Metabolic Surgery. We will examine the effectiveness of a social media-supported intervention group, and therefore, the change in self-efficacy expectation. For the primary outcome, we will perform a mixed analysis of variance with time as the within-subject factor (times of measurement T0–T4) and the group assignment as the between-subject factor (intervention +TAU vs TAU group).Ethics and disseminationThe study was approved by the Medical Association North Rhine (Ärztekammer Nordrhein, 2020031) and the patient enrolment will begin in July 2021.Trial registration numberDRKS00018089.

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

scholarly journals Early intervention in panic: pragmatic randomised controlled trial

2010 ◽  
Vol 196 (4) ◽  
pp. 326-331 ◽  
Author(s):  
Peter Meulenbeek ◽  
Godelief Willemse ◽  
Filip Smit ◽  
Anton van Balkom ◽  
Philip Spinhoven ◽  
...  
Keyword(s):  
Early Intervention ◽  
Panic Disorder ◽  
Group Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Report ◽  
Control Group ◽  
Cognitive Behavioural ◽  
Clinically Significant ◽  
Randomised Controlled

BackgroundMany people suffer from subthreshold and mild panic disorder and are at risk of developing more severe panic disorder.AimsThis study (trial registration: ISRCTN33407455) was conducted to evaluate the effectiveness of an early group intervention based on cognitive–behavioural principles to reduce panic disorder symptomatology.MethodParticipants with subthreshold or mild panic disorder were recruited from the general population and randomised to the intervention (n = 109) or a waiting-list control group (n = 108). The course was offered by 17 community mental health centres.ResultsIn the early intervention group, 43/109 (39%) participants presented with a clinically significant change on the Panic Disorder Severity Scale–Self Report (PDSS–SR) v. 17/108 (16%) in the control group (odds ratio (OR) for favourable treatment response 3.49, 95% CI 1.77–6.88, P = 0.001). The course also had a positive effect on DSM–IV panic disorder status (OR = 1.96, 95% CI=1.05–3.66, P = 0.037). The PDSS–SR symptom reduction was also substantial (between-group standardised mean difference of 0.68). The effects were maintained at 6-month follow-up.ConclusionsPeople presenting with subthreshold and mild panic disorder benefit from this brief intervention.

scholarly journals Student-Reported Classroom Climate Pre and Post Teacher Training in Restorative Practices

2021 ◽  
Vol 6 ◽  
Author(s):  
Constanze Weber ◽  
Merle Rehder ◽  
Leen Vereenooghe
Keyword(s):  
Classroom Climate ◽  
Social Inclusion ◽  
Intervention Group ◽  
Well Being ◽  
Self Report ◽  
Controlled Study ◽  
Restorative Practices ◽  
Special Educational Needs ◽  
Single Class ◽  
Randomised Controlled

Restorative practices (RP) offer a means to establish positive and caring relationships and could thus foster the mental and scholastic development of students by improving classroom climate. This could benefit both students with and without special educational needs and disabilities (SEND), yet to date no studies evaluated these practices in inclusive educational settings. Here we report the findings of two consecutive studies: a pilot single-group pre-post (Study 1) and a non-randomised controlled study of RP training vs no-intervention control condition (Study 2). Across both studies, 531 students (46.5% female) with a mean age of 11.43 years (SD = 1.27) enrolled in the study at pre-test, of which 13.9% had a confirmed diagnosis of SEND and a further 5.7% were considered by teachers to likely have SEND. School and classroom climate, as well as victimisation experiences, emotional well-being and social inclusion of students were assessed using self-report questionnaires. Easy enrolment of schools and students at pre-test indicated that studies investigating the effects of RP training could be feasible. However, in part due to COVID-19 related school closures, student attrition rates of 90 and 77% were observed, for Study 1 and Study 2 respectively. In spite of observed improvements in classroom climate for the intervention group in Study 2, statistical analyses yielded no significant effects of the intervention and there were no moderation effects of students’ perceived inclusion and victimisation experiences. Together, these studies provide the first quantitative student data on implementing RP in an inclusive educational setting. We discuss our findings in light of the need for ideas on how to reduce attrition and also consider longer school-wide and single-class implementations of RP.

scholarly journals Primary Care and Physical Literacy: A Non-Randomized Controlled Pilot Study to Combat the High Prevalence of Physically Inactive Adults in Austria

2021 ◽  
Vol 18 (16) ◽  
pp. 8593
Author(s):  
Peter Holler ◽  
Johannes Jaunig ◽  
Othmar Moser ◽  
Silvia Tuttner ◽  
Helmut Simi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Pilot Study ◽  
Self Efficacy ◽  
Intervention Group ◽  
Physical Activity Behavior ◽  
Controlled Study ◽  
Control Group ◽  
Physical Literacy ◽  
Randomized Controlled ◽  
Activity Behavior

The multidimensional concept of physical literacy is fundamental for lifelong physical activity engagement. However, physical literacy-based interventions are in their infancy, especially among adults. Therefore, the purpose of this pilot study was to assess the association of a physical literacy-based intervention with changes in self-reported physical literacy among inactive adults. A non-randomized controlled study (2 × 2 design) was conducted, comparing pre- vs. postintervention. Twenty-eight inactive healthy participants in the intervention group (89% female, 53 ± 10 years) entered a physical literacy-based intervention once weekly for 14 weeks. The non-treated control group consisted of 22 inactive adults (96% female, 50 ± 11 years). Physical literacy was evaluated with a questionnaire encompassing five domains: physical activity behavior, attitude/understanding, motivation, knowledge, and self-efficacy/confidence. ANOVA models were applied to evaluate changes by time and condition. Following the intervention, significant improvements were seen for overall physical literacy and in four out of five physical literacy domains, including physical activity behavior, attitude/understanding, knowledge, and self-efficacy/confidence (all p < 0.01, Cohen’s d = 0.38–0.83). No changes by time x condition were found for motivation. The physical literacy-based intervention applied in this study may be a promising approach to help inactive adults to adopt an active lifestyle.

scholarly journals Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 659 ◽  
Author(s):  
Jennifer McCaffery ◽  
Alex Mitchell ◽  
Caroline Fairhurst ◽  
Sarah Cockayne ◽  
Sara Rodgers ◽  
...  
Keyword(s):  
Intervention Group ◽  
Small Sample ◽  
Controlled Study ◽  
Control Group ◽  
Trial Participant ◽  
Invitation Letter ◽  
Wide Range ◽  
Study Within A Trial ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Methods: A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial.  Secondary outcomes related to trial eligibility and retention.  Analyses were via logistic regression and Cox Proportional Hazards regression. Results: Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes. Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations. Registration: ISRCTN22202133.

scholarly journals Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e034655
Author(s):  
Andy S K Cheng ◽  
Xiangyu Liu ◽  
Peter H F Ng ◽  
Cindy T T Kwok ◽  
Yingchun Zeng ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Breast Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Readiness For Change ◽  
Self Management ◽  
Controlled Study ◽  
Control Group ◽  
Problem Solving Skills ◽  
Randomised Controlled

IntroductionThe eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.Methods and analysisThis is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app (‘Be-with-You’), while the control group will use a general health app (‘Sham’ app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.Ethics and disseminationThe Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.Trial registration numberChiCTR1900026244.

scholarly journals Effectiveness of a Pediatric Emergency Medicine Curriculum in a Public Tanzanian Referral Hospital

2019 ◽  
Vol 21 (1) ◽  
pp. 134-140
Author(s):  
Carol Chen ◽  
Alexander Werne ◽  
Katharine Osborn ◽  
Holly Vo ◽  
Upendo George ◽  
...  
Keyword(s):  
Emergency Medicine ◽  
Test Scores ◽  
Self Efficacy ◽  
Intervention Group ◽  
Pediatric Emergency ◽  
Referral Hospital ◽  
World Health ◽  
Controlled Study ◽  
Pediatric Emergency Medicine ◽  
Knowledge Test

Introduction: The World Health Organization recently recognized the importance of emergency and trauma care in reducing morbidity and mortality. Training programs are essential to improving emergency care in low-resource settings; however, a paucity of comprehensive curricula focusing specifically on pediatric emergency medicine (PEM) currently exists. The African Federation for Emergency Medicine (AFEM) developed a PEM curriculum that was pilot-tested in a non-randomized, controlled study to evaluate its effectiveness in nurses working in a public Tanzanian referral hospital. Methods: Fifteen nurses were recruited to participate in a two-and-a-half-day curriculum of lectures, skill sessions, and simulation scenarios covering nine topics; they were matched with controls. Both groups completed pre- and post-training assessments of their knowledge (multiple-choice test), self-efficacy (Likert surveys), and behavior. Changes in behavior were assessed using a binary checklist of critical actions during observations of live pediatric resuscitations. Results: Participant-rated pre-training self-efficacy and knowledge test scores were similar in both control and intervention groups. However, post-training, self-efficacy ratings in the intervention group increased by a median of 11.5 points (interquartile range [IQR]: 6-16) while unchanged in the control group. Knowledge test scores also increased by a median of three points (IQR: 0-4) in the nurses who received the training while the control group’s results did not differ in the two periods. A total of 1192 pediatric resuscitation cases were observed post-training, with the intervention group demonstrating higher rates of performance of three of 27 critical actions. Conclusion: This pilot study of the AFEM PEM curriculum for nurses has shown it to be an effective tool in knowledge acquisition and improved self-efficacy of pediatric emergencies. Further evaluation will be needed to assess whether it is currently effective in changing nurse behavior and patient outcomes or whether curricular modifications are needed.

A Multicentre Randomised Controlled Study Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study

Dermatology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Fatma Jendoubi ◽  
Stefana Balica ◽  
Marie Aleth Richard ◽  
Christine Chiaverini ◽  
Claire Bernier ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Intervention Group ◽  
Education Programme ◽  
Controlled Study ◽  
Control Group ◽  
Randomised Controlled Study ◽  
Randomised Controlled ◽  
To Receive

<b><i>Background:</i></b> Psoriasis is a chronic inflammatory skin disease that has a profound effect on health-related quality of life (HRQoL). Patient education programmes may help patients to gain life-long control over their chronic disease. <b><i>Objective:</i></b> This multicentre randomised controlled study evaluated whether a standardised multidisciplinary education programme was beneficial to psoriasis patients. <b><i>Methods:</i></b> Adults with moderate-to-severe psoriasis were randomly assigned (1:1) to an intervention group to receive an educational programme or to a control group to receive usual care. Randomization was stratified by previous treatment history. The primary outcome was HRQoL, assessed by scoring the Skindex-29 domains emotion, symptom, and functioning. Psoriasis severity was assessed using the psoriasis area severity index (PASI). Levels of perceived stress, patient knowledge about psoriasis, and patient satisfaction were also assessed. Follow-up evaluations were performed at 3, 6, and 12 months. <b><i>Results:</i></b> A total 142 patients formed the intention-to-treat population: 70 in the control group and 72 in the intervention group. Skindex component scores and the PASI were significantly lower at 3, 6, and 12 months as compared to baseline in both groups, but no significant differences were found between the groups. Knowledge about psoriasis improved significantly during follow-up amongst patients from the intervention group compared to controls (68% of correct answers vs. 56%; <i>p</i> &#x3c; 0.01). Patient satisfaction with psoriasis management and treatment was also better in the intervention group. <b><i>Conclusions:</i></b> The standardised education programme did not improve HRQoL and disease severity in psoriasis, but led to a significant improvement in patient knowledge about the disease and increased patient satisfaction.

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