scholarly journals Supporting women undergoing IVF treatment with timely patient information through an app: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Thomas Timmers ◽  
Manouk Keijsers ◽  
Jan AM Kremer ◽  
Loes Janssen ◽  
Jesper Smeenk
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Education ◽  
Assisted Reproductive Technologies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Reproductive Technologies ◽  
Randomized Controlled ◽  
Level Of Satisfaction ◽  
Level Of Knowledge ◽  
The Right

BACKGROUND Since the introduction of assisted reproductive technologies in 1978, over 2 million IVF (in vitro fertilization) babies have been born worldwide. Patients play a vital role in the chances of success for this treatment. They are required to take fertility medication (hormone injections) to activate the ovaries to produce a sufficient number of oocytes. Later on, they need to take medication to increase the chance of the embryo surviving inside the uterus. To minimize emotional burden and to reduce the risk of being non-compliant, patients are educated during an intake consultation at the start of the treatment. The consultation lasts about 30 to 45 minutes and covers all important subjects. Even though ample time and energy is spent on patient education, patients still feel anxious, unknowledgeable and unsupported. This is where electronic health (eHealth) by means of an app for smartphone or tablet comes in, as it allows healthcare professionals to provide their patients with the right information at the right time by using push-notifications. OBJECTIVE The aim of this randomized controlled trial was to evaluate an app to support IVF and ICSI patients throughout the different phases of their treatment, and to assess its effectiveness. The primary outcome of the study is patients’ level of satisfaction with the information they were provided with. The secondary outcomes were their level of knowledge, ability to administer the medication, overall experienced quality of the treatment and healthcare consumption. METHODS This study was performed at specialized fertility clinic of the non-academic teaching hospital Elisabeth-TweeSteden Ziekenhuis (ETZ) in Tilburg, The Netherlands. Between April 2018 and August 2019, patients who were scheduled for IVF or ICSI treatment were invited to participate in a physician-blinded, randomized controlled trial. RESULTS In total, 54 patients participated (intervention group n=29). At the first measurement, patients in the intervention group demonstrated a higher level of satisfaction. In addition, they reported to be more knowledgeable about the different elements of the treatment. Over time, this difference disappeared. There were no differences between patients on the other outcomes. CONCLUSIONS Our study demonstrates that, in comparison with standard patient education, using an app to provide patients with timely information, increases their level of satisfaction. Furthermore, using the app leads to a higher level of knowledge about the steps and procedures during the IVF treatment. The app’s usage statistics clearly display patients’ information needs, and their willingness to use an eHealth application as part of their treatment. CLINICALTRIAL Netherlands Trial Register (NTR): 6959; https://www.trialregister.nl/trial/6959

EndoART: A proposed randomized controlled trial on endometriomas in assisted reproductive technologies, comparing the effect of no intervention, surgery, and prolonged GnRH downregulation on pregnancy rates

2018 ◽  
Vol 10 (3) ◽  
pp. 158-173 ◽  
Author(s):  
Carla Tomassetti ◽  
David Adamson ◽  
Aydin Arici ◽  
Michel Canis ◽  
Peter Hompes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Fetal Heart ◽  
Assisted Reproductive Technologies ◽  
Controlled Trial ◽  
Reproductive Technologies ◽  
Heart Beat ◽  
Pregnancy Rates ◽  
Clinical Pregnancy ◽  
Randomized Controlled ◽  
Ovarian Surgery

Background: Clinical management of endometriomas, prior to starting treatment with assisted reproductive technologies (ART), has since long been a matter of debate. Whereas cystectomy has been advocated in the past, recently more evidence has emerged on the potential negative effect of surgery on ovarian reserve. Parallel to this, prolonged downregulation with GnRH-a (gonadotropin-releasing hormone agonists) has been described to improve ART pregnancy rates in women with endometriosis. However, none of these strategies have been assessed in a large randomized controlled trial. The aim of the EndoART study is to assess whether ovarian surgery or prolonged GnRH-a downregulation result in higher pregnancy rates after ART compared to no intervention in women with endometrioma(s). Methods/design: A parallel randomized multi-center trial has been designed to compare ART pregnancy rates in three different treatment groups: no intervention, ovarian surgery, and prolonged hormonal suppression by GnRH-a prior to ART. The primary outcome measure studied is the clinical pregnancy rate with fetal heart-beat within 6 months after initiation of a fresh ART cycle. Secondary outcome measures studied include live birth rate after one initiated fresh ART cycle, cumulative clinical pregnancy rate with fetal heart-beat and live birth rates (after one fully completed ART cycle: initiated fresh + eventual associated frozen embryo transfer cycles), ART–specific data (e.g. number of oocytes, number of good quality embryos), complications, pelvic pain, and quality of life. Conclusion: This trial may answer the most frequently asked questions by both women with endometriosis and physicians: how do you treat endometrioma in women prior to treatment with ART?

scholarly journals EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Valentina Meta Srikartika ◽  
M. Rasyid Akbar ◽  
Herningtyas Nautika Lingga
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Level Of Knowledge ◽  
Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

scholarly journals The Role of Patient Education in Total Knee Arthroplasty: a new methodology for developing countries: a randomized controlled trial

2021 ◽  
Author(s):  
Marco Antonio Percope de Andrade ◽  
Guilherme Moreira Abreu e Silva ◽  
Tulio Vinicius Oliveira Campos ◽  
David Guen Kasuya Barbosa ◽  
Danilo Silva Leite ◽  
...  
Keyword(s):  
Developing Countries ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Patient Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Walk Ability ◽  
Total Knee

Abstract Background: The illiteracy index is high in public hospitals of developing countries,. We established a method in which patients are instructed before total knee arthroplasty (TKA) in a differentiated way without the necessity of reading any self-orientation. Methods: We developed a multidisciplinary approach to improve patient education in TKA comprising of a differentiated orientation conducted by an orthopedic surgeon, a nurse and a physiotherapist. It consists of standardized lectures regarding on pre, intra and post-operative issues in a randomized controlled trial of 79 consecutive patients undergoing primary TKA. Thirty-four patients received the standard education (control group) and 45 patients received the differentiated education (intervention group). The patients were evaluated during at least six months. Results: After a 6-month follow-up period, the Short Form Health Survey (SF-36), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the visual analogue pain scale (VAS) and knee range-of-motion (ROM) improved significantly in both groups. Range-of-motion was better in the intervention group (mean and SD - 106.9 ± 5.7 versus 92.5 ± 12.1 degrees, p = 0.02). Moreover, walk ability (more than 400 meters) was better in the intervention group compared with the control group (97.4% versus 72.4%, p = 0.003). In the intervention and control groups, respectively, 10.5% and 31% of patients reported the need for some walking devices (p = 0.03). Conclusions: A differentiated educational program with a multidisciplinary team had a positive impact on functional outcomes, improving ROM and walk ability of patients undergoing TKA in a short-term evaluation.

scholarly journals A Cluster Randomized Controlled Trial of a Total Worker Health® Intervention on Commercial Construction Sites

2018 ◽  
Vol 15 (11) ◽  
pp. 2354 ◽  
Author(s):  
Susan Peters ◽  
Michael Grant ◽  
Justin Rodgers ◽  
Justin Manjourides ◽  
Cassandra Okechukwu ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Worker Health ◽  
Cluster Randomized ◽  
The Right ◽  
Total Worker Health

This study evaluated the efficacy of an integrated Total Worker Health® program, “All the Right Moves”, designed to target the conditions of work and workers’ health behaviors through an ergonomics program combined with a worksite-based health promotion Health Week intervention. A matched-pair cluster randomized controlled trial was conducted on ten worksites (five intervention (n = 324); five control sites (n = 283)). Worker surveys were collected at all sites pre- and post- exposure at one- and six-months. Linear and logistic regression models evaluated the effect of the intervention on pain and injury, dietary and physical activity behaviors, smoking, ergonomic practices, and work limitations. Worker focus groups and manager interviews supplemented the evaluation. After controlling for matched intervention and control pairs as well as covariates, at one-month following the ergonomics program we observed a significant improvement in ergonomic practices (B = 0.20, p = 0.002), and a reduction in incidences of pain and injury (OR = 0.58, p = 0.012) in the intervention group. At six months, we observed differences in favor of the intervention group for a reduction in physically demanding work (B = −0.25, p = 0.008), increased recreational physical activity (B = 35.2, p = 0.026) and higher consumption of fruits and vegetables (B = 0.87, p = 0.008). Process evaluation revealed barriers to intervention implementation fidelity and uptake, including a fissured multiemployer worksite, the itinerant nature of workers, competing production pressures, management support, and inclement weather. The All the Right Moves program had a positive impact at the individual level on the worksites with the program. For the longer term, the multi-organizational structure in the construction work environment needs to be considered to facilitate more upstream, long-term changes.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Effects of tDCS during inhibitory control training on performance and PTSD, aggression and anxiety symptoms: a randomized-controlled trial in a military sample

2021 ◽  
pp. 1-11
Author(s):  
Fenne M. Smits ◽  
Elbert Geuze ◽  
Dennis J. L. G. Schutter ◽  
Jack van Honk ◽  
Thomas E. Gladwin
Keyword(s):  
Randomized Controlled Trial ◽  
Inhibitory Control ◽  
Response Inhibition ◽  
Clinical Sample ◽  
Controlled Trial ◽  
Anodal Tdcs ◽  
Randomized Controlled ◽  
Impulsive Aggression ◽  
The Right ◽  
Inhibition Training

Abstract Background Post-traumatic stress disorder (PTSD), anxiety, and impulsive aggression are linked to transdiagnostic neurocognitive deficits. This includes impaired inhibitory control over inappropriate responses. Prior studies showed that inhibitory control can be improved by modulating the right inferior frontal gyrus (IFG) with transcranial direct current stimulation (tDCS) in combination with inhibitory control training. However, its clinical potential remains unclear. We therefore aimed to replicate a tDCS-enhanced inhibitory control training in a clinical sample and test whether this reduces stress-related mental health symptoms. Methods In a preregistered double-blind randomized-controlled trial, 100 active-duty military personnel and post-active veterans with PTSD, anxiety, or impulsive aggression symptoms underwent a 5-session intervention where a stop-signal response inhibition training was combined with anodal tDCS over the right IFG for 20 min at 1.25 mA. Inhibitory control was evaluated with the emotional go/no-go task and implicit association test. Stress-related symptoms were assessed by self-report at baseline, post-intervention, and after 3-months and 1-year follow-ups. Results Active relative to sham tDCS neither influenced performance during inhibitory control training nor on assessment tasks, and did also not significantly influence self-reported symptoms of PTSD, anxiety, impulsive aggression, or depression at post-assessment or follow-up. Conclusions Our results do not support the idea that anodal tDCS over the right IFG at 1.25 mA enhances response inhibition training in a clinical sample, or that this tDCS-training combination can reduce stress-related symptoms. Applying different tDCS parameters or combining tDCS with more challenging tasks might provide better conditions to modulate cognitive functioning and stress-related symptoms.

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