scholarly journals The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Macey L Henderson ◽  
Alvin G Thomas ◽  
Ann K Eno ◽  
Madeleine M Waldram ◽  
Jaclyn Bannon ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
The United States ◽  
Secondary Outcome ◽  
Hospital Level ◽  
Process Data ◽  
Randomized Controlled ◽  
The Impact

BACKGROUND Every year, more than 5500 healthy people in the United States donate a kidney for the medical benefit of another person. The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to monitor living kidney donors (LKDs) for 2 years postdonation. However, the majority (115/202, 57%) of transplant hospitals in the United States continue to fail to meet nationally mandated requirements for LKD follow-up. A novel method for collecting LKD follow-up is needed to ease both the transplant hospital-level and patient-level burden. We built mKidney—a mobile health (mHealth) system designed specifically to facilitate the collection and reporting of OPTN-required LKD follow-up data. The mKidney mobile app was developed on the basis of input elicited from LKDs, transplant providers, and thought leaders. OBJECTIVE The primary objective of this study is to evaluate the impact of the mKidney smartphone app on LKD follow-up rates. METHODS We will conduct a two-arm randomized controlled trial (RCT) with LKDs who undergo LKD transplantation at Methodist Specialty and Transplant Hospital in San Antonio, Texas. Eligible participants will be recruited in-person by a study team member at their 1-week postdonation clinical visit and randomly assigned to the intervention or control arm (1:1). Participants in the intervention arm will receive the mHealth intervention (mKidney), and participants in the control arm will receive the current standard of follow-up care. Our primary outcome will be policy-defined complete (all components addressed) and timely (60 days before or after the expected visit date) submission of LKD follow-up data at required 6-month, 1-year, and 2-year visits. Our secondary outcome will be hospital-level compliance with OPTN reporting requirements at each visit. Data analysis will follow the intention-to-treat principle. Additionally, we will collect quantitative and qualitative process data regarding the implementation of the mKidney system. RESULTS We began recruitment for this RCT in May 2018. We plan to enroll 400 LKDs over 2 years and follow participants for the 2-year mandated follow-up period. CONCLUSIONS This pilot RCT will evaluate the impact of the mKidney system on rates of LKD and hospital compliance with OPTN-mandated LKD follow-up at a large LKD transplant hospital. It will provide valuable information on strategies for implementing such a system in a clinical setting and inform effect sizes for future RCT sample size calculations. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11000

A Randomized Controlled Trial of Professional Development for Interdisciplinary Civic Education: Impacts on Humanities Teachers and Their Students

2015 ◽  
Vol 117 (2) ◽  
pp. 1-52
Author(s):  
Dennis J. Barr ◽  
Beth Boulay ◽  
Robert L. Selman ◽  
Rachel Mccormick ◽  
Ethan Lowenstein ◽  
...  
Keyword(s):  
Professional Development ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
The United States ◽  
Performance Measure ◽  
Civic Learning ◽  
Randomized Controlled ◽  
10Th Grade ◽  
The Impact

Background/Context Billions of dollars are spent annually on professional development (PD) for educators, yet few randomized controlled trials (RCT) have demonstrated the ultimate impact PD has on student learning. Further, while policymakers and others speak to the role schools should play in developing students’ civic awareness, RCTs of PD designed to foster civic learning are rare. This randomized controlled trial contributes to the knowledge base on the effectiveness of PD designed to integrate civic learning, ethical reflection, and historical thinking skills into high school humanities courses. Focus of Study The study examined the impact of a PD intervention in two areas: (a) teacher self-efficacy, burnout, and professional engagement and satisfaction; and (b) the academic, civic, social, and ethical competencies of 9th and 10th grade students in the teachers’ classes. Population/Participants/Subjects The study involved 113 teachers and 1,371 9th and 10th grade students in 60 high schools from eight metropolitan regions in the United States. Intervention/Program/Practice The intervention, Facing History and Ourselves, provides PD through a five-day seminar, curricular materials, and follow-up coaching and workshops to help teachers develop their capacities to implement an interdisciplinary historical case study unit using student-centered pedagogy. Research Design The study used a school-level, randomized, experimental design to investigate impacts of the intervention for teachers and their 9th and 10th grade students. Findings/Results Intervention teachers showed significantly greater self-efficacy in all eight assessed domains, more positive perceptions of professional support, satisfaction and growth, and greater personal accomplishment. Intervention students demonstrated stronger skills for analyzing evidence, agency, and cause and effect on a historical understanding performance measure; greater self-reported civic efficacy and tolerance for others with different views; and more positive perceptions of the classroom climate and the opportunities afforded for engaging with civic matters. Fidelity analysis found these causal effects despite the fact that roughly half of the intervention teachers did not fully implement the program. Conclusions/Recommendations Educators need evidence-based approaches for teaching complex social, civic, and political issues enabling students of diverse mindsets and backgrounds to engage constructively with one another while obtaining necessary skills and knowledge. These findings provide empirical support for a professional development approach that engages teachers in fostering academic and civic competencies critical to both participation in a democracy and success in college and career.

scholarly journals Dissemination of the Look AHEAD Intensive Lifestyle Intervention in the United States Military: A Randomized Controlled Trial

Obesity ◽  
2018 ◽  
Vol 26 (10) ◽  
pp. 1558-1565 ◽  
Author(s):  
Rebecca A. Krukowski ◽  
Marion E. Hare ◽  
Gerald W. Talcott ◽  
Leslie A. Gladney ◽  
Karen C. Johnson ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
The United States ◽  
United States Military ◽  
Randomized Controlled ◽  
Intensive Lifestyle Intervention ◽  
Look Ahead ◽  
The Look

scholarly journals Effects of Side-Effect Risk Framing Strategies on COVID-19 Vaccine Intentions in the United States and the United Kingdom: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Nikkil Sudharsanan ◽  
Caterina Favaretti ◽  
Violetta Hachaturyan ◽  
Till Baernighausen ◽  
Alain Vandormael
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Side Effect ◽  
Motor Vehicle ◽  
Controlled Trial ◽  
The United States ◽  
Randomized Controlled ◽  
The United Kingdom ◽  
Percentage Points ◽  
Framing Strategies

Vaccination rates have stagnated in the United States and the United Kingdom leading to the continuing spread of COVID-19. Fear and concern over vaccine side-effects is one of the main drivers of hesitancy. Drawing from behavioral science and health communication theory, we conducted a randomized controlled trial among 8998 adults to determine whether the way COVID-19 vaccine side-effects are framed and presented to individuals can influence their willingness to take a vaccine. We presented participants information on a hypothetical future COVID-19 vaccine -- including information on its side-effect rate -- and then examined the effect of three side-effect framing strategies on individuals stated willingness to take this vaccine: adding a qualitative risk label next to the numerical risk, adding comparison risks, and for those presented with comparisons, framing the comparison in relative rather than absolute terms. Based on a pre-registered and published analysis plan, we found that adding a simple descriptive risk label (very low risk) next to the numerical side-effect increased participants' willingness to take the COVID-19 vaccine by 3.0 percentage points (p = 0.003). Providing a comparison to motor vehicle mortality increased COVID-19 vaccine willingness by 2.4 percentage points (p = 0.051). These effects were independent and additive: participants that received both a qualitative risk label and comparison to motor-vehicle mortality were 6.1 percentage points (p < 0.001) more likely to report willingness to take a vaccine compared to those who did not receive a label or comparison. Taken together, our results reveal that despite increasingly strong vaccination hesitancy and exposure to large amounts of vaccine misinformation, low-cost side-effect framing strategies can meaningfully affect vaccination intentions at a population level.

scholarly journals Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Feng Bin Lin ◽  
◽  
Shi Da Chen ◽  
Yun He Song ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intraocular Pressure ◽  
High Myopia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rank Test ◽  
Inner Plexiform Layer ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

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.

The effects of vestibular rehabilitation on dizziness and balance problems in patients after traumatic brain injury: a randomized controlled trial

2018 ◽  
Vol 33 (1) ◽  
pp. 74-84 ◽  
Author(s):  
Ingerid Kleffelgaard ◽  
Helene Lundgaard Soberg ◽  
Anne-Lise Tamber ◽  
Kari Anette Bruusgaard ◽  
Are Hugo Pripp ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Vestibular Rehabilitation ◽  
Secondary Outcome ◽  
Group Differences ◽  
Randomized Controlled ◽  
Balance Problems

Objective: To investigate the effects of group-based vestibular rehabilitation in patients with traumatic brain injury. Design: A single-blind randomized controlled trial. Setting: University Hospital (recruitment and baseline assessments) and Metropolitan University (experimental intervention). Subjects: A total of 65 patients (45 women) with mild-to-moderate traumatic brain injury (mean age 39.4 ± 13.0 years) were randomly assigned to intervention ( n = 33) or control group ( n = 32). Intervention: Group-based vestibular rehabilitation for eight weeks. Participants were tested at baseline (3.5 ± 2.1 months after injury) and at two post-intervention follow-ups (2.7 ± 0.8 and 4.4 ± 1.0 months after baseline testing). Main measures: Primary outcome: Dizziness Handicap Inventory. Secondary outcome: High-Level Mobility Assessment Tool. Other outcomes: Vertigo Symptom Scale; Rivermead Post-concussion Symptoms Questionnaire; Hospital Anxiety and Depression Scale; and Balance Error Scoring System. Between-group differences were analyzed with a linear mixed-model analysis for repeated measurements. Results: At baseline, no group differences were revealed (personal factors, clinical characteristics and outcome measures). At the first follow-up, statistically significant mean differences in favor of the intervention were found in the primary (−8.7, 95% confidence interval (CI): −16.6 to −0.9) and secondary outcomes (3.7 points, 95% CI: 1.4–6.0). At the second follow-up, no significant between-group differences were found. No significant between-group differences in the other outcomes were found at the two follow-ups. Conclusion: The intervention appeared to speed up recovery for patients with dizziness and balance problems after traumatic brain injury. However, the benefits had dissipated two months after the end of the intervention.

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