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Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial.

ABSTRACT: Obstructive sleep apnea (OSA) is a sleep disorder that disproportionately affects African Americans (hereafter referred to as blacks). Moreover, blacks may underutilize sleep services including overnight polysomnography. Thus, OSA among blacks may go undiagnosed and untreated, which has significant health consequences, including hypertension, diabetes, cognitive impairment, and daytime sleepiness.This two-arm randomized controlled trial will assign 200 participants to a culturally and linguistically tailored web-based sleep educational platform. The website will be developed to ensure that the content is user friendly and that it is readable and acceptable by the target community. Participants will receive login information to a password-protected website and will have access to the website for 2 months. Study assessments will be collected at baseline, 2 months (post-enrollment) and at 6 months (follow-up). We will use qualitative and quantitative methods to develop tailored materials and to ascertain whether tailored materials will increase OSA knowledge and OSA health literacy by comparing blacks exposed to tailored materials versus those exposed to standard sleep health literature. We hypothesize that exposure to tailored OSA information will improve OSA health literacy.Few studies have investigated the racial/ethnic disparities in relation to OSA screening and treatment comparing blacks and whites. Moreover, we know of no interventions designed to increase OSA knowledge and health literacy among blacks. Use of the Internet to disseminate health information is growing in this population. Thus, the Internet may be an effective means to increase OSA health literacy, thereby potentially increasing utilization of sleep-related services in this population.The study is registered at clinicaltrials.gov, reference number NCT02507089 . Registered on 21 July 2015.

SUBMITTER: Williams NJ

PROVIDER: S-EPMC5146895 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial.

Williams Natasha J NJ Robbins Rebecca R Rapoport David D Allegrante John P JP Cohall Alwyn A Ogedgebe Gbenga G Jean-Louis Girardin G

Trials 20161208 1

<h4>Background</h4>Obstructive sleep apnea (OSA) is a sleep disorder that disproportionately affects African Americans (hereafter referred to as blacks). Moreover, blacks may underutilize sleep services including overnight polysomnography. Thus, OSA among blacks may go undiagnosed and untreated, which has significant health consequences, including hypertension, diabetes, cognitive impairment, and daytime sleepiness.<h4>Design and methods</h4>This two-arm randomized controlled trial will assign 2 ...[more]

PMID: 27931249

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Project description:BackgroundStroke is a leading cause of adult disability and mortality. Intravenous thrombolysis can minimize disability when patients present to the emergency department for treatment within the 3 - 4½ h of symptom onset. Blacks and Hispanics are more likely to die and suffer disability from stroke than whites, due in part to delayed hospital arrival and ineligibility for intravenous thrombolysis for acute stroke. Low stroke literacy (poor knowledge of stroke symptoms and when to call 911) among Blacks and Hispanics compared to whites may contribute to disparities in acute stroke treatment and outcomes. Improving stroke literacy may be a critical step along the pathway to reducing stroke disparities. The aim of the current study is to test a novel intervention to increase stroke literacy in minority populations in New York City.Design and methodsIn a two-arm cluster randomized trial, we will evaluate the effectiveness of two culturally tailored stroke education films - one in English and one in Spanish - on changing behavioral intent to call 911 for suspected stroke, compared to usual care. These films will target knowledge of stroke symptoms, the range of severity of symptoms and the therapeutic benefit of calling 911, as well as address barriers to timely presentation to the hospital. Given the success of previous church-based programs targeting behavior change in minority populations, this trial will be conducted with 250 congregants across 14 churches (125 intervention; 125 control). Our proposed outcomes are (1) recognition of stroke symptoms and (2) behavioral intent to call 911 for suspected stroke, measured using the Stroke Action Test at the 6-month and 1-year follow-up.DiscussionThis is the first randomized trial of a church-placed narrative intervention to improve stroke outcomes in urban Black and Hispanic populations. A film intervention has the potential to make a significant public health impact, as film is a highly scalable and disseminable medium. Since there is at least one church in almost every neighborhood in the USA, churches have the ability and reach to play an important role in the dissemination and translation of stroke prevention programs in minority communities.Trial registrationNCT01909271 ; July 22, 2013.

Project description:BackgroundCompared to whites, blacks are at increased risk for obstructive sleep apnea (OSA) yet less likely to adhere to physician-recommended sleep assessment and treatment. Poor OSA health literacy and lack of social support to navigate the current healthcare system are two potential barriers to adequate OSA care. This study is designed to address these barriers by evaluating the effectiveness of a peer-based sleep health education program on adherence to OSA assessment and treatment among blacks at risk for OSA.Method/designIn a two-arm, randomized controlled trial, we will ascertain the effectiveness of peer-based sleep health education and social support in increasing OSA evaluation and treatment rates among 398 blacks at low to high OSA risk. Participants at risk of OSA will receive quality controlled, culturally, and linguistically tailored peer education based on Motivational Enhancement principles over a period of 12 months. During this 12-month period, participants are encouraged to participate in a sleep home study to determine risk of OSA and, if found to be at risk, they are invited to undergo a diagnostic sleep assessment at a clinic. Participants who are diagnosed with OSA and who are prescribed continuous positive airway pressure treatment will be encouraged, through peer-based education, to adhere to recommended treatment. Recruitment for the project is ongoing.DiscussionThe use of a culturally tailored sleep health education program, peer health educators trained in sleep health, and home-based sleep assessment are novel approaches in improving OSA assessment and treatment adherence in blacks who are significantly at risk for OSA. Empirical evidence from this trial will provide clinical and population level solutions on how to improve and increase assessment and treatment of OSA among blacks.Trial registrationNCT02427815 . Registered on 20 April 2015. ClinicalTrials.gov title: Sleep Health Education and Social Support Among Blacks With OSA.

Project description:BackgroundEntertainment-education media can be an effective strategy for influencing health behaviors. To improve entertainment-education effectiveness, we seek to investigate whether the social authority of a person delivering a health message arouses the motivation to reject that message-a phenomenon known as reactance.ObjectiveIn this study, using a short animated video, we aim to measure reactance to a sugar reduction message narrated by a child (low social authority), the child's mother (equivalent social authority to the target audience), and a family physician (high social authority). The aims of the study are to determine the effect of the narrator's perceived social authority on reactance to the sugar reduction message, establish the effectiveness of the video in improving behavioral intent to reduce the intake of added sugars, and quantify participants' interest in watching the entertainment-education intervention video.MethodsThis is a parallel group, randomized controlled trial comparing an intervention video narrated by a low, equivalent, or high social authority against a content placebo video and a placebo video. Using a web-based recruitment platform, we plan to enroll 4000 participants aged between 18 and 59 years who speak English and reside in the United Kingdom. The primary end points will include measures of the antecedents to reactance (proneness to reactance and threat level of the message), its components (anger and negative cognition), and attitudinal and behavioral intent toward sugar intake. We will measure behavioral intent using list experiments. Participants randomized to the placebo videos will be given a choice to watch one of the sugar-intervention videos at the end of the study to assess participant engagement with the entertainment-education video.ResultsThe study was approved by the ethics committee of Heidelberg University on March 18, 2020 (S-088/2020). Participant recruitment and data collection were completed in December 2020. The data analysis was completed in April 2021, and the final results are planned to be published by August 2021.ConclusionsIn this trial, we will use several randomization procedures, list experimentation methods, and new web-based technologies to investigate the effect of perceived social authority on reactance to a message about reducing sugar intake. Our results will inform the design of future entertainment-education videos for public health promotion needs.Trial registrationGerman Clinical Trials Registry DRKS00022340: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022340.International registered report identifier (irrid)DERR1-10.2196/25343.

Project description:BackgroundSoaring health care costs and a rapidly aging population, with multiple comorbidities, necessitates the development of innovative strategies to deliver high-quality, value-based care.ObjectiveThe goal of this study is to evaluate the impact of a risk assessment system (CareSage) and targeted interventions on health care utilization.MethodsThis is a two-arm randomized controlled trial recruiting 370 participants from a pool of high-risk patients receiving care at a home health agency. CareSage is a risk assessment system that utilizes both real-time data collected via a Personal Emergency Response Service and historical patient data collected from the electronic medical records. All patients will first be observed for 3 months (observation period) to allow the CareSage algorithm to calibrate based on patient data. During the next 6 months (intervention period), CareSage will use a predictive algorithm to classify patients in the intervention group as "high" or "low" risk for emergency transport every 30 days. All patients flagged as "high risk" by CareSage will receive nurse triage calls to assess their needs and personalized interventions including patient education, home visits, and tele-monitoring. The primary outcome is the number of 180-day emergency department visits. Secondary outcomes include the number of 90-day emergency department visits, total medical expenses, 180-day mortality rates, time to first readmission, total number of readmissions and avoidable readmissions, 30-, 90-, and 180-day readmission rates, as well as cost of intervention per patient. The two study groups will be compared using the Student t test (two-tailed) for normally distributed and Mann Whitney U test for skewed continuous variables, respectively. The chi-square test will be used for categorical variables. Time to event (readmission) and 180-day mortality between the two study groups will be compared by using the Kaplan-Meier survival plots and the log-rank test. Cox proportional hazard regression will be used to compute hazard ratio and compare outcomes between the two groups.ResultsWe are actively enrolling participants and the study is expected to be completed by end of 2018; results are expected to be published in early 2019.ConclusionsInnovative solutions for identifying high-risk patients and personalizing interventions based on individual risk and needs may help facilitate the delivery of value-based care, improve long-term patient health outcomes and decrease health care costs.Trial registrationClinicalTrials.gov NCT03126565; https://clinicaltrials.gov/ct2/show/NCT03126565 (Archived by WebCite at http://www.webcitation.org/6ymDuAwQA).

Project description:BACKGROUND:Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). METHODS/DESIGN:The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. DISCUSSION:This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. TRIAL REGISTRATION:ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

Project description:BackgroundSleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.MethodsThe study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months.DiscussionThe negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.Trial registrationClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).

Project description:BackgroundOsteoarthritis is a common and disabling condition that places heavy burden to individuals and healthcare systems. Patient education is a facilitator in the treatment decision making process, aiming to develop a treatment plan for the disease management. Electronic health (eHealth) is an alternative forum for the delivery of patient education and given the prevailing of eHealth in healthcare, introducing patient education programs using the technology has the potential to improve patient engagement, self-management and outcomes in patients with osteoarthritis. The study will evaluate the efficacy of eHealth patient education tool on patients' perception of knee osteoarthritis and treatment options, satisfaction and compliance to treatments.MethodsThis study is a prospective randomized controlled trial with a 1:1 allocation in two groups. We will recruit 216 patients diagnosed with knee osteoarthritis from the outpatient physiatry/physiotherapy clinic at West China Hospital, Sichuan University in Southwest China. Both groups will receive usual care and additionally, the intervention group will use eHealth patient education tool during the process. Measurements will be taken at baseline, post-intervention, 1 month, 3- and 6-months follow-up. Primary outcome will be patients' knowledge about disease and treatment options, measured by the validated osteoarthritis patient knowledge questionnaire. Secondary outcomes include patients' satisfaction with the consultation, the eHealth patient education tool, and their trust of the physiotherapist.DiscussionThe eHealth patient education tool is designed to provide participants with an innovative model of care delivery and this trial will assess the efficacy of the tool and whether this new model of patient education will have the potential to increase patient knowledge and empower self-management. Results collected from this study will further inform future research employing eHealth tool as interventions for the management of a range of other chronic conditions and help participants in communities or rural areas having the equal access to health care services.Trial registrationThis study was prospectively registered on the Chinese Clinical Trials Registry ( ChiCTR2100051083 ) registered 12.09.2021.

Project description:BACKGROUND:School-based comprehensive sexual health education can improve adolescent health outcomes, and web-based programs are a promising approach to overcoming challenges associated with teacher-led formats by ensuring that students receive content that is consistent, unbiased, and medically accurate. However, many adolescents do not receive high-quality sexual health education and turn to the media for information about sex and relationships. Consumption of sexual media messages is related to early and risky sexual behaviors. Media literacy education (MLE) is a proven approach to adolescent sexual health promotion, yet there are no rigorously evaluated web-based MLE programs to promote sexual and relationship health among high school students. METHODS:This study will test the efficacy, in a randomized controlled trial, of Media Aware, a web-based comprehensive sexual health promotion program for high school students that uses an MLE approach. Participants will be students in 9th and 10th grade health classes in participating schools. Randomization will take place at the school level, and data collection will take place at three time points (i.e., pretest, posttest, and 3 months follow-up). Students in the intervention classrooms will receive Media Aware between pretest and posttest, and students in the delayed-intervention classrooms will receive Media Aware after study completion (i.e., after 3 months follow-up data collection). Students in the delayed-intervention classes will receive their standard health education programming, and teachers in the delayed-intervention classes will be asked to refrain from teaching sexual health or MLE during the study timeframe. The primary outcome variables are intentions, willingness, and behaviors related to sexual health and sexual activity. DISCUSSION:There are currently no evidence-based comprehensive sexual health programs for high school students that are web-based and use an MLE approach. Media Aware has the potential to be an engaging, less expensive, and effective sexual and relationship health program for high school students. Media Aware is unique in two important ways: (1) the web-based format reduces many of the challenges to fidelity of implementation associated with teacher-led sexual health education; and (2) the MLE approach addresses a commonly ignored influence on adolescent sexual and relationship health, namely, media. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04035694. Registered on 29 July 2019. Contact for Scientific Queries: Tracy Scull, PhD (Principal Investigator); innovation Research & Training at 5316 Highgate Drive, Suite 121, Durham, North Carolina, USA 27713; tscull@irtinc.us.

Project description:BackgroundThere is an ongoing debate whether electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers because despite this uncertainty, e-cigarettes are used by many smokers to reduce and quit tobacco smoking.ObjectiveThe aim of this study is to describe the protocol of a randomized controlled trial that assesses the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention.MethodsA randomized controlled trial with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. In this trial, which is grounded on the I-Change model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on 6 clusters of smoking cessation methods (face-to-face counselling, eHealth interventions, telephone counselling, group-based programs, nicotine replacement therapy, and prescription medication) will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes, while smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision making (ie, knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires.ResultsThis project is supported by a research grant of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu). Ethical approval was granted by the Ethics Review Committee Health, Medicine and Life Sciences at Maastricht University (FHML-REC/2019/072). Recruitment began in March 2020 and was completed by July 2020. We enrolled 492 smokers in this study. The results are expected to be published in June 2021.ConclusionsThe experimental design of this study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision making and smoking behavior. Our findings can inform the development of future smoking cessation interventions.Trial registrationDutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330.International registered report identifier (irrid)DERR1-10.2196/27088.

Dataset Information

Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial.

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Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial.

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