scholarly journals The impact of a digital wheeze detector on parental disease management of pre-school children suffering from wheezing—a pilot study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Stephanie Dramburg ◽  
Ellen Dellbrügger ◽  
Wim van Aalderen ◽  
Paolo Maria Matricardi
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Airway Obstruction ◽  
Controlled Trial ◽  
Electronic Diary ◽  
Asthma Control Test ◽  
Randomized Controlled ◽  
Airway Infections ◽  
The Impact

Abstract Background Viral airway infections are a major reason for doctor’s visits at pre-school age, especially when associated with wheezing. While proper treatment requires adequate recognition of airway obstruction, caretakers are often struggling with this judgment, consequently leading to insufficient or late treatment and an unnecessary discomfort of the patient. Digital technologies may serve to support parental decision taking. The aim of the present pilot study is to acquire data on the feasibility of recruitment and observation procedures for a randomized controlled trial on the impact of a digital wheeze detector in a home management setting of pre-school wheezing. Methods This single-armed pilot study enrolled patients with a doctor’s diagnosis of wheezing aged 9 to 72 months. Participants were asked to use a digital wheeze detector (WheezeScan, Omron Healthcare, Japan) 2×/day for 30 days and record the child’s respiratory symptoms, detection of wheezing, and medication intake via an electronic diary (eDiary) app. Demographic and clinical data were collected at the recruitment visit. The asthma control test and the Parent Asthma Management Self-Efficacy Scale (PAMSES) were assessed both, at recruitment and follow-up. Results Twenty families were recruited and completed the monitoring. All but one completed the follow-up after 30 days. The recruitment procedures were feasible, and adherence to daily monitoring reached an average of 81%. The use of the wheeze detector was rated as uncomplicated. Parents detected wheezing without digital support in only 22/708 (3.1%) of the recorded events. By contrast, the wheeze detector indicated an airway obstruction in 140/708 (19.8%) of the recordings. Conclusion In parallel to feasible recruitment procedures, we observed good usability of the wheeze detection device and high adherence to eDiary recording. The positive outcomes show that the WheezeScan may empower parents by increasing their capacity for wheeze detection. This deserves to be investigated in a larger randomized controlled trial.

scholarly journals Does a tailored intervention to promote adherence in patients with chronic lung disease affect exacerbations? A randomized controlled trial

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Claudia Gregoriano ◽  
Thomas Dieterle ◽  
Anna-Lisa Breitenstein ◽  
Selina Dürr ◽  
Amanda Baum ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ambulatory Setting ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Copd Patients ◽  
The Impact ◽  
Inhaled Medication

Abstract Background Poor medication-adherence is common in chronic lung patients, resulting in reduced health-outcomes and increased healthcare-costs. This study aimed to investigate the impact of an acoustic reminder and support calls on adherence to inhaled therapy in asthma and COPD patients and to determine their effect on exacerbations. Methods This single-blinded randomized controlled trial investigated asthma and COPD patients during 6 months in an ambulatory setting. The intervention consisted of daily alarm clock and support phone calls, whenever use of rescue medication doubled or inhaled medication was not taken as prescribed. Primary outcome was time to next exacerbation. Frequency of exacerbations, adherence to inhaled medication and quality of life scores were secondary outcomes. Cox and Poisson regression were used to determine intervention effect on time to exacerbation and frequency of exacerbations, respectively. Results Seventy-five participants were assigned to the intervention group and 74 to usual follow-up care. During a median follow-up of 6.2 months, 22 and 28% in the intervention and control groups respectively, experienced at least one exacerbation. Intervention had no effect on time to first exacerbation (HR 0.65, 95% CI 0.21 to 2.07, P = .24), but showed a trend toward a 39% decreased frequency of exacerbations (RR = 0.61, 95% CI 0.35 to 1.03, P = .070) for the adjusted models, respectively. The intervention group had significantly more days with 80–100% taking adherence regarding puff inhalers (82 ± 14% vs. 60 ± 30%, P < .001) and dry powder capsules (90 ± .10% vs. 80 ± 21%, P = .01). Timing adherence in participants using puff inhalers was higher in the intervention group (69 ± 25% vs. 51 ± 33%, P < .001). No significant differences in QoL were found between the two groups. Conclusion Participants assigned to the intervention group had significantly better taking and timing adherence of inhaled medication resulting in a trend towards a decreased frequency of exacerbations. However, no effect on time to next exacerbation was observed. Trial registration ClinicalTrials.gov: NCT02386722, Registered 14 February 2014.

scholarly journals Implementation of a School Physical Activity Policy Improves Student Physical Activity Levels: Outcomes of a Cluster-Randomized Controlled Trial

2020 ◽  
Vol 17 (10) ◽  
pp. 1009-1018
Author(s):  
Nicole K. Nathan ◽  
Rachel L. Sutherland ◽  
Kirsty Hope ◽  
Nicole J. McCarthy ◽  
Matthew Pettett ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
School Day ◽  
Cluster Randomized ◽  
The Impact

Aim: To assess the impact of a multistrategy intervention designed to improve teachers’ implementation of a school physical activity (PA) policy on student PA levels. Methods: A cluster-randomized controlled trial was conducted in 12 elementary schools. Policy implementation required schools to deliver 150 minutes of organized PA for students each week via physical education, sport, or class-based activities such as energizers. Schools received implementation support designed using the theoretical domains framework to help them implement the current policy. Results: A total of 1,502 children in kindergarten to grade 6 participated. At follow-up compared with control, students attending intervention schools had, measured via accelerometer, significantly greater increases in school day counts per minute (97.5; 95% confidence interval [CI], 64.5 to 130.4; P < .001) and moderate to vigorous physical activity (MVPA) (3.0; 95% CI, 2.2–3.8, P < .001) and a greater decrease in sedentary time (−2.1; 95% CI, −3.9 to −0.4, P = .02) per school day. Teachers in intervention schools delivered significantly more minutes (36.6 min) of PA to their students at follow-up (95% CI, 2.7–70.5, P = .04). Conclusions: Supporting teachers to implement a PA policy improves student PA. Additional strategies may be needed to support teachers to implement activities that result in larger gains in student MVPA.

scholarly journals Impact of Medication Regimen Simplification on Medication Administration Times and Health Outcomes in Residential Aged Care: 12 Month Follow Up of the SIMPLER Randomized Controlled Trial

2020 ◽  
Vol 9 (4) ◽  
pp. 1053 ◽  
Author(s):  
Janet K. Sluggett ◽  
Ria E. Hopkins ◽  
Esa YH Chen ◽  
Jenni Ilomäki ◽  
Megan Corlis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Medication Administration ◽  
Aged Care ◽  
Residential Aged Care ◽  
Medication Regimen ◽  
Term Care ◽  
Randomized Controlled ◽  
The Impact

In the SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) cluster-randomized controlled trial, we evaluated the impact of structured medication regimen simplification on medication administration times, falls, hospitalization, and mortality at 8 residential aged care facilities (RACFs) at 12 month follow up. In total, 242 residents taking ≥1 medication regularly were included. Opportunities for simplification among participants at 4 RACFs were identified using the validated Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE). Simplification was possible for 62 of 99 residents in the intervention arm. Significant reductions in the mean number of daily medication administration times were observed at 8 months (−0.38, 95% confidence intervals (CI) −0.69 to −0.07) and 12 months (−0.47, 95%CI −0.84 to −0.09) in the intervention compared to the comparison arm. A higher incidence of falls was observed in the intervention arm (incidence rate ratio (IRR) 2.20, 95%CI 1.33 to 3.63) over 12-months, which was primarily driven by a high falls rate in one intervention RACF and a simultaneous decrease in comparison RACFs. No significant differences in hospitalizations (IRR 1.78, 95%CI 0.57–5.53) or mortality (relative risk 0.81, 95%CI 0.48–1.38) over 12 months were observed. Medication simplification achieves sustained reductions in medication administration times and should be implemented using a structured resident-centered approach that incorporates clinical judgement.

Bayesian methods for pilot studies

2020 ◽  
Vol 17 (4) ◽  
pp. 414-419 ◽  
Author(s):  
Andrew R Willan ◽  
Lehana Thabane
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Bayesian Methods ◽  
Controlled Trial ◽  
Recruitment Strategies ◽  
Pilot Studies ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Study Results

Background/aims: The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining the feasibility of an associated randomized controlled trial. Methods: An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial. Results: The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial. Conclusion: Applying Bayesian methods to pilot studies’ results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

scholarly journals MON-LB012 Long-Term Developmental Impact of Withholding Parenteral Nutrition in Pediatric-ICU: A 4-Year Follow-Up of the Pepanic Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
An Jacobs ◽  
Karolijn Dulfer ◽  
Renate Eveleens ◽  
José Hordijk ◽  
Hanna Van Cleemput ◽  
...  
Keyword(s):  
Dna Methylation ◽  
Randomized Controlled Trial ◽  
Health Status ◽  
Parenteral Nutrition ◽  
Behavioral Problems ◽  
Controlled Trial ◽  
Cpg Sites ◽  
Randomized Controlled ◽  
The Impact

Abstract Aim: Between 2012-2015, the PEPaNIC randomized controlled trial, which included 1440 critically ill infants and children, showed that withholding parenteral nutrition during the first week in the pediatric intensive care unit (PICU) (late-PN), as compared with initiating supplemental PN early (early-PN), improved PICU outcomes (1) and improved neurocognitive development assessed 2 years later (2). The latter was explained by avoiding early-PN induced adversely altered DNA-methylation of 37 CpG sites (3). As a large number of patients were younger than 1 year of age at randomization and given that assessment of most neurocognitive domains is only possible from 4 years of age onwards, we performed a 4-year follow-up to determine the impact of late-PN versus early-PN on physical, neurocognitive, and emotional/behavioral development. This pre-planned, 4-year follow-up study of the 1440 PEPaNIC patients and of 369 matched healthy children was blinded for treatment allocation (ClinicalTrials.gov-NCT01536275). Methods: Studied clinical outcomes included anthropometrics, health status, parent/caregiver-reported executive functions, and emotional/behavioral problems, and clinical tests for intelligence, visual-motor integration, alertness, motor coordination and memory. Univariable and multivariable linear and logistic regression analyses adjusted for risk factors assessed the impact of late-PN versus early-PN on the outcomes and investigated a potential mediation role of the adversely altered DNA-methylation of 37 CpG sites previously shown to be evoked by late-PN as compared with early-PN (3). Results: Overall, at 4 years follow-up, patients (356 late-PN patients, 328 early-PN patients) could be tested neurocognitively. They revealed worse anthropometric, health status, neurocognitive and emotional/behavioral developmental outcomes than the healthy control children. Outcomes of late-PN patients were never worse than those of early-PN patients. In contrast, late-PN patients had fewer internalizing (P=0.042) and externalizing problems (P=0.046), and fewer total emotional/behavioral problems (P=0.007) than early-PN patients, which were normalized by late-PN. Avoiding the early-PN induced adversely altered DNA-methylation status of the 37 CpG sites statistically explained its impact on the behavioral outcomes. Conclusion: Four years after randomization to late-PN or early-PN in the PICU, late-PN did not show harm, and was found to protect against emotional/behavioral problems, with altered DNA-methylation as a potential biological mediator hereof. These data further support de-implementation of PN-use early during critical illness in infants and children. (1) Fivez et al. N Eng J Med 2016 (2) Verstraete et al. Lancet Respir Med 2019 (3) Guiza et al. Lancet Respir Med 2020 (in press)

scholarly journals The Impact of Automated Notification on Follow-up of Actionable Tests Pending at Discharge: a Cluster-Randomized Controlled Trial

2018 ◽  
Vol 33 (7) ◽  
pp. 1043-1051 ◽  
Author(s):  
Anuj K. Dalal ◽  
Adam Schaffer ◽  
Esteban F. Gershanik ◽  
Ranganath Papanna ◽  
Katyuska Eibensteiner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact
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