scholarly journals The effect of smaller classes on infection-related school absence: Evidence from the Project STAR randomized controlled trial

2021 ◽  
Author(s):  
Paul T von Hippel
Keyword(s):  
Class Size ◽  
Significant Interaction ◽  
Reporting System ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Disease Prevalence ◽  
Viral Transmission ◽  
Randomized Controlled ◽  
School Absence ◽  
Reduce Class Size

In an effort to reduce viral transmission, many schools are planning to reduce class size if they have not reduced it already. Yet the effect of class size on transmission is unknown. To determine whether smaller classes reduce school absence, especially when community disease prevalence is high, we merge data from the Project STAR randomized class size trial with influenza and pneumonia data from the 122 Cities Mortality Reporting System on deaths from pneumonia and influenza. Project STAR was a block-randomized trial that followed 10,816 Tennessee schoolchildren from kindergarten in 1985-86 through third grade in 1988-89. Children were assigned at random to small classes (13 to 17 students), regular-sized classes (22 to 26 students), and regular-sized class with a teachers aide. Mixed effects regression showed that small classes reduced absence, but not necessarily by reducing infection. In particular, small classes reduced absence by 0.43 days/year (95% CI -0.06 to -0.80, p<0.05), but had no significant interaction with pneumonia and influenza mortality (95% CI -0.27 to +0.30, p>0.90). Small classes, by themselves, may not suffice to reduce the spread of viruses.

scholarly journals The Effect of Active Plus, a Computer-Tailored Physical Activity Intervention, on the Physical Activity of Older Adults with Chronic Illness(es)—A Cluster Randomized Controlled Trial

2020 ◽  
Vol 17 (7) ◽  
pp. 2590
Author(s):  
Esmee Volders ◽  
Catherine A. W. Bolman ◽  
Renate H. M. de Groot ◽  
Peter Verboon ◽  
Lilian Lechner
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Mixed Effects Models ◽  
Linear Mixed Effects Models ◽  
Linear Mixed Effects ◽  
Randomized Controlled ◽  
Objectively Measured

eHealth interventions aimed at improving physical activity (PA) can reach large populations with few resources and demands on the population as opposed to centre-based interventions. Active Plus is a proven effective computer-tailored PA intervention for the older adult population focusing on PA in daily life. This manuscript describes the effects of the Active Plus intervention (N = 260) on PA of older adults with chronic illnesses (OACI), compared to a waiting list control group (N = 325). It was part of a larger randomized controlled trial (RCT) on the effects of the Active Plus intervention on cognitive functioning. OACI (≥65 years) with at least one chronic illness were allocated to one of the conditions. Intervention group participants received PA advice. Baseline and follow-up measurements were assessed after 6 and 12 months. Intervention effects on objectively measured light PA (LPA) and moderate-to-vigorous PA (MVPA) min/week were analysed with multilevel linear mixed-effects models adjusted for the clustered design. Intervention effects on self-reported MVPA min/week on common types of PA were analysed with two-part generalized linear mixed-effects models adjusted for the clustered design. The dropout rate was 19.1% after 6 months and 25.1% after 12 months. Analyses showed no effects on objectively measured PA. Active Plus increased the likelihood to perform self-reported cycling and gardening at six months and participants who cycled increased their MVPA min/week of cycling. Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling. Subgroup analyses showed that more vulnerable participants (higher degree of impairment, age or body mass index) benefitted more from the intervention on especially the lower intensity PA outcomes. In conclusion, Active Plus only increased PA behaviour to a limited extent in OACI 6 and 12 months after baseline measurements. The Active Plus intervention may yet be not effective enough by itself in OACI. A blended approach, where this eHealth intervention and face-to-face contact are combined, is advised to improve the effects of Active Plus on PA in this target group.

scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Lay Health Worker ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background: While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods: The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. There are 56Primary Health Centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each, and the intervention is rolled out in a staggered manner in these groups of villages at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the WHO Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire, (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire, (GAD-7) and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model are employed for binary outcomes and linear mixed effects models for continuous outcomes. A Return on investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project. Discussion: Stepped wedge designs are progressively being used to evaluate real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a LMIC evaluating the impact of implementation of a psychosocial mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in LMICs.

scholarly journals Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
David C Mohr ◽  
Stephen M Schueller ◽  
Kathryn Noth Tomasino ◽  
Susan M Kaiser ◽  
Nameyeh Alam ◽  
...  
Keyword(s):  
Significant Interaction ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Randomized Controlled ◽  
Marginal Effects ◽  
Patient Health ◽  
Common Mental Health Problems ◽  
Modular Platform ◽  
All Treatment

BACKGROUND IntelliCare is a modular platform that includes 12 simple apps targeting specific psychological strategies for common mental health problems. OBJECTIVE This study aimed to examine the effect of 2 methods of maintaining engagement with the IntelliCare platform, coaching, and receipt of weekly recommendations to try different apps on depression, anxiety, and app use. METHODS A total of 301 participants with depression or anxiety were randomized to 1 of 4 treatments lasting 8 weeks and were followed for 6 months posttreatment. The trial used a 2X2 factorial design (coached vs self-guided treatment and weekly app recommendations vs no recommendations) to compare engagement metrics. RESULTS The median time to last use of any app during treatment was 56 days (interquartile range 54-57), with 253 participants (84.0%, 253/301) continuing to use the apps over a median of 92 days posttreatment. Receipt of weekly recommendations resulted in a significantly higher number of app use sessions during treatment (overall median=216; P=.04) but only marginal effects for time to last use (P=.06) and number of app downloads (P=.08). Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08). Participants showed significant reductions in the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) across all treatment arms (P s<.001). Coached treatment led to larger GAD-7 reductions than those observed for self-guided treatment (P=.03), but the effects for the PHQ-9 did not reach significance (P=.06). Significant interaction was observed between receiving recommendations and time for the PHQ-9 (P=.04), but there were no significant effects for GAD-7 (P=.58). CONCLUSIONS IntelliCare produced strong engagement with apps across all treatment arms. Coaching was associated with stronger anxiety outcomes, and receipt of recommendations enhanced depression outcomes. CLINICALTRIAL ClinicalTrials.gov NCT02801877; https://clinicaltrials.gov/ct2/show/NCT02801877

scholarly journals Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial

10.2196/13609 ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. e13609 ◽  
Author(s):  
David C Mohr ◽  
Stephen M Schueller ◽  
Kathryn Noth Tomasino ◽  
Susan M Kaiser ◽  
Nameyeh Alam ◽  
...  
Keyword(s):  
Significant Interaction ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Generalized Anxiety ◽  
Randomized Controlled ◽  
Marginal Effects ◽  
Patient Health ◽  
Common Mental Health Problems ◽  
Modular Platform ◽  
All Treatment

Background IntelliCare is a modular platform that includes 12 simple apps targeting specific psychological strategies for common mental health problems. Objective This study aimed to examine the effect of 2 methods of maintaining engagement with the IntelliCare platform, coaching, and receipt of weekly recommendations to try different apps on depression, anxiety, and app use. Methods A total of 301 participants with depression or anxiety were randomized to 1 of 4 treatments lasting 8 weeks and were followed for 6 months posttreatment. The trial used a 2X2 factorial design (coached vs self-guided treatment and weekly app recommendations vs no recommendations) to compare engagement metrics. Results The median time to last use of any app during treatment was 56 days (interquartile range 54-57), with 253 participants (84.0%, 253/301) continuing to use the apps over a median of 92 days posttreatment. Receipt of weekly recommendations resulted in a significantly higher number of app use sessions during treatment (overall median=216; P=.04) but only marginal effects for time to last use (P=.06) and number of app downloads (P=.08). Coaching resulted in significantly more app downloads (P<.001), but there were no significant effects for time to last download or number of app sessions (P=.36) or time to last download (P=.08). Participants showed significant reductions in the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) across all treatment arms (P s<.001). Coached treatment led to larger GAD-7 reductions than those observed for self-guided treatment (P=.03), but the effects for the PHQ-9 did not reach significance (P=.06). Significant interaction was observed between receiving recommendations and time for the PHQ-9 (P=.04), but there were no significant effects for GAD-7 (P=.58). Conclusions IntelliCare produced strong engagement with apps across all treatment arms. Coaching was associated with stronger anxiety outcomes, and receipt of recommendations enhanced depression outcomes. Trial Registration ClinicalTrials.gov NCT02801877; https://clinicaltrials.gov/ct2/show/NCT02801877

scholarly journals Different Amounts of Water Supplementation Improved Cognitive Performance and Mood among Young Adults after 12 h Water Restriction in Baoding, China: A Randomized Controlled Trial (RCT)

2020 ◽  
Vol 17 (21) ◽  
pp. 7792
Author(s):  
Jianfen Zhang ◽  
Na Zhang ◽  
Hairong He ◽  
Songming Du ◽  
Guansheng Ma
Keyword(s):  
Young Adults ◽  
Cognitive Performance ◽  
Test Scores ◽  
Significant Interaction ◽  
Controlled Trial ◽  
Water Restriction ◽  
Randomized Controlled ◽  
Group 2 ◽  
Water Supplementation ◽  
Group 1

Water is indispensable to keeping the functions of the human body working properly, including that of the brain. The purpose of this research was to explore the impacts of water supplementation on cognitive performance and mood, and to determine the optimum amount of water to alleviate detriments of dehydration after 12 h water restriction. A randomized controlled trial was implemented among 64 young adults from Baoding, China. Fasting overnight for 12 h, and at 8:00 a.m. on day 2, osmolality of first morning urine and blood, cognitive performance, and mood were assessed as the dehydration test. Then, participants were randomly separated into four groups: water supplementation groups (WS groups 1, 2, and 3 with 500, 200, and 100 mL purified water, respectively) and no water supplementation group (NW group). Participants in WS groups were instructed to drink the water within 10 min, while those in NW group drank no water. After 90 min, the same measurements were taken as the rehydration test. There was significant interaction between TIME and VOLUME in thirst when comparing dehydration with rehydration tests (F = 6.172, p = 0.001). Significant thirst reductions were found in WS group 1 and WS group 2 (p = 0.003; p = 0.041), and a significant increase was found in the NW group (p = 0.039). In the rehydration test, significant interactions between TIME and VOLUME were found in scores of anger, fatigue, and TMD (total mood disturbance) (F = 3.815, p = 0.014; F = 10.429, p < 0.001; F = 5.246, p < 0.001), compared to the dehydration test. Scores of anger were only decreased in WS group 2 (p = 0.025), and scores of fatigue and TMD decreased in WS group 1 and WS group 2 (all p < 0.05). Significant interaction between TIME and VOLUME was only found for operation span test scores (F = 2.816, p = 0.047), with scores being only higher in WS group 1 in the rehydration test compared to the dehydration test (p = 0.003). Comparing WS group 1 and WS group 2, scores of thirst, fatigue, and TMD did not differ significantly (p > 0.05). Water supplementation improved working memory and attenuated anger, fatigue, and TMD. A small amount of water (200 mL) was sufficient to attenuate thirst, anger, fatigue, and TMD of young adults, but the larger volume (500 mL) appeared to be necessary to improve working memory. The amount of 500 mL was the optimum volume to improve the cognitive performance and mood among young adults.

scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Lay Health Worker ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. 56 PHCs in Mehsana district are equally divided into four clusters of 14 PHCs each, and the intervention is rolled out in cluster in a staggered manner at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-reporting questionnaire-20 (SRQ-20), functioning using the WHO Disability Assessment Scale (WHO-DAS-12), depression symptoms (Patient Health Questionnaire, PHQ-9)) and anxiety symptoms (Generalized Anxiety Disorder Questionnaire, GAD-7) and social participation using the Social Participation Scale (SPS). Linear mixed effects models are employed for continuous outcomes and generalized linear mixed effects model for binary outcomes. Discussion Stepped wedge designs are progressively being used to evaluate real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a LMIC evaluating the impact of the implementation of a mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in LMICs.

scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background: While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods: The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. There are 56 primary health centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each, and the intervention is rolled out in a staggered manner in these groups of villages at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the World Health Organization’s Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire, (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire, (GAD-7) and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model are employed for binary outcomes and linear mixed effects models for continuous outcomes. A Return on Investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project.

scholarly journals Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pragmatic Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
William Martinez ◽  
Amber J. Hackstadt ◽  
Gerald B. Hickson ◽  
S. Trent Rosenbloom ◽  
Tom A. Elasy
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Diabetes Care ◽  
Controlled Trial ◽  
Patient Activation ◽  
Health Data ◽  
Mixed Effects ◽  
Patient Portal ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled

BACKGROUND My Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt (MHAV), at Vanderbilt University Medical Center (VUMC). MDC is designed to help patients better understand their diabetes health data as well as support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, contains secure-messaging capability, and links to a diabetes online patient support community and diabetes news feeds. OBJECTIVE Our study aims to evaluate the effects of MDC on patient activation among adult patients with type 2 diabetes mellitus (T2DM). In addition, we plan to assess secondary outcomes including system usage and usability and effects of MDC on cognitive and behavioral outcomes (e.g., self-care and self-efficacy). METHODS We are conducting a 6-month, 2-arm, parallel-design, pragmatic randomized controlled trial (RCT) of the effect of MDC on patient activation. Adult patients with T2DM are recruited from primary care clinics affiliated with VUMC. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, able to speak and read in English, age 21 or over, and have an existing MHAV account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long term care facilities, with known cognitive deficits or severe visual impairment, and currently participating in another diabetes related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data including the Patient Activation Measure® at baseline, 3-months, and 6 months. We will use mixed effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed effects model will use fixed effects for patient level characteristics and random effects for health care provider variables, such primary care physician. RESULTS The study is ongoing. Recruitment closed May 2020 and 270 patients were randomized. Of those randomized, the majority (80.1%, 214/267) are white non-Hispanic, 13.1% (35/267) are black non-Hispanic, 43.7% (118/270) reported being 65 or older, and 33.6% (90/268) reported limited health literacy. We have at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment. CONCLUSIONS This RCT will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic’s MyChart platform with more than 127 million patient health records, our intervention is directly integrated into routine care and is highly scalable and sustainable. Our findings and evolving patient portal functionality will inform the continued development of the intervention to best meet users’ needs as well as a larger trial focused on the impact of MDC on clinical endpoints. CLINICALTRIAL ClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333

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