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Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial.

ABSTRACT: Mobility scooters can facilitate community participation among individuals with mobility limitations. However, accidents are a serious concern with scooter use. Scooter training has been recommended to improve safety, but there are currently few validated programs available. Therefore, we developed a Systematic, Comprehensive, One-to-One Training (SCOOT) program for scooter users. We will conduct a study to evaluate the outcomes produced by the provision SCOOT.This feasibility study will use a mixed-methods, rater-blinded, randomized control trial, with a two-step wedge design. The study has two arms: an immediate intervention group, which will receive the intervention directly after baseline assessments, and a delayed intervention group, which will receive the intervention after a 6-week period. Forty participants, who will be stratified based on whether or not participants have previously held a driver's license, will be randomly assigned to each arm. The intervention for this study consists of 6 weeks of one-to-one scooter training by an experienced occupational therapist, who will provide training once or twice per week over the 6 weeks. The primary outcome measure is subjective scooter skills, measured using the Wheelchair Skills Test for scooters. Secondary outcomes include objective scooter skills, confidence, mobility, and satisfaction with selected participation activities. Descriptive measures include cognitive status, functional status, hearing, vision, physical accessibility of the home and community, and visual attention and task switching. Qualitative interviews will be conducted with the first ten willing participants from each group to learn about their scooter use and experiences with SCOOT.The results of this study will inform a larger randomized control trial. If the intervention is proven to be effective in this larger study, it may have important implications for policy and practice.ClinicalTrials.gov identifier: NCT02696213 . Registered on 23 February 2016.

SUBMITTER: Mortenson WB

PROVIDER: S-EPMC5445361 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial.

Mortenson W Ben WB Jang Sharon S Goldsmith Charlie H CH Hurd Clarke Laura L Hobson Sandra S Emery Richelle R

Trials 20170525 1

<h4>Background</h4>Mobility scooters can facilitate community participation among individuals with mobility limitations. However, accidents are a serious concern with scooter use. Scooter training has been recommended to improve safety, but there are currently few validated programs available. Therefore, we developed a Systematic, Comprehensive, One-to-One Training (SCOOT) program for scooter users. We will conduct a study to evaluate the outcomes produced by the provision SCOOT.<h4>Methods</h4> ...[more]

PMID: 28545498

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Project description:BackgroundMental health problems affect 1 in 6 workers annually and are one of the leading causes of sickness absence, with stress, anxiety, and depression being responsible for half of all working days lost in the United Kingdom. Primary interventions with a preventative focus are widely acknowledged as the priority for workplace mental health interventions. Line managers hold a primary role in preventing poor mental health within the workplace and, therefore, need to be equipped with the skills and knowledge to effectively carry out this role. However, most previous intervention studies have directly focused on increasing line managers' understanding and awareness of mental health rather than giving them the skills and competencies to take a proactive preventative approach in how they manage and design work. The Managing Minds at Work (MMW) digital training intervention was collaboratively designed to address this gap. The intervention aims to increase line managers' knowledge and confidence in preventing work-related stress and promoting mental health at work. It consists of 5 modules providing evidence-based interactive content on looking after your mental health, designing and managing work to promote mental well-being, management competencies that prevent work-related stress, developing a psychologically safe workplace, and having conversations about mental health at work.ObjectiveThe primary aim of this study is to pilot and feasibility test MMW, a digital training intervention for line managers.MethodsWe use a cluster randomized controlled trial design consisting of 2 arms, the intervention arm and a 3-month waitlist control, in this multicenter feasibility pilot study. Line managers in the intervention arm will complete a baseline questionnaire at screening, immediately post intervention (approximately 6 weeks after baseline), and at 3- and 6-month follow-ups. Line managers in the control arm will complete an initial baseline questionnaire, repeated after 3 months on the waitlist. They will then be granted access to the MMW intervention, following which they will complete the questionnaire post intervention. The direct reports of the line managers in both arms of the trial will also be invited to take part by completing questionnaires at baseline and follow-up. As a feasibility pilot study, a formal sample size is not required. A minimum of 8 clusters (randomized into 2 groups of 4) will be sought to inform a future trial from work organizations of different types and sectors.ResultsRecruitment for the study closed in January 2022. Overall, 24 organizations and 224 line managers have been recruited. Data analysis was finished in August 2023.ConclusionsThe results from this feasibility study will provide insight into the usability and acceptability of the MMW intervention and its potential for improving line manager outcomes and those of their direct reports. These results will inform the development of subsequent trials.Trial registrationClinicalTrials.gov NCT05154019; https://clinicaltrials.gov/study/NCT05154019.International registered report identifier (irrid)DERR1-10.2196/48758.

Project description:IntroductionFalls are a serious concern for wheelchair and scooter users with multiple sclerosis (MS). Approximately, 75% of the population reports at least one fall in a 6-month period and nearly half report frequent falls. Falls can result in physical injuries and contribute to activity curtailment. Despite the negative consequences, limited evidenced-based fall prevention programs designed specifically for wheelchair and scooter users with MS exist.PurposeRecognizing the threat falls pose to health and well-being and the dearth of fall prevention programs, the purpose of this study is to perform a structured process evaluation and examine the feasibility and efficacy of a community-based intervention specifically designed to reduce fall incidence among wheelchair and scooter users with MS. Secondary aims of the intervention are to improve functional mobility skills associated with fall risk (e.g., transfer and wheelchair skills, balance), increase knowledge of fall risk factors, decrease fear of falling, and enhance quality of life and community participation.MethodsTo evaluate our specific aims, a clinical trial will be performed with 160 wheelchair and scooter users with MS. (ClinicalTrials.gov Identifier: NCT03705364). Participants will be recruited to participate in a small group-style community-based program. The content of the program will be based on factors found to be associated with falls among wheelchair and scooter users with MS. These factors include but are not limited to, wheelchair/scooter related characteristics, transfer activities, impaired seated balance, and environmental factors. A physical or occupational therapist, will implement the intervention, which is comprised of 6 sessions that occur once weekly. The incidence of falls, along with an examination of wheelchair/scooter and transfer skills, seated postural control and knowledge of fall related risk factors will be compared between intervention and control participants, with assessment periods occurring prior to the intervention, 1 to 2 weeks after completion of the 6-week intervention session, and 12 weeks after the intervention period is complete.ConclusionResults from this study will guide the refinement of the intervention program and inform future research among a large and diverse group of wheelchair and scooter users living with MS.

Project description:BackgroundChildren born preterm may display cognitive, learning, and behaviour difficulties as they grow up. In particular, very premature birth (gestation age between 28 and less than 32 weeks) may put infants at increased risk of intellectual deficits and attention deficit disorder. Evidence suggests that the basis of these problems may lie in difficulties in the development of executive functions. One of the earliest executive functions to emerge around 1 year of age is the ability to control attention. An eye-tracking-based cognitive training programme to support this emerging ability, the Attention Control Training (ACT), has been developed and tested with typically developing infants. The aim of this study is to investigate the feasibility of using the ACT with healthy very preterm (VP) infants when they are 12 months of age (corrected age). The ACT has the potential to address the need for supporting emerging cognitive abilities of VP infants with an early intervention, which may capitalise on infants' neural plasticity.Methods/designThe feasibility study is designed to investigate whether it is possible to recruit and retain VP infants and their families in a randomised trial that compares attention and social attention of trained infants against those that are exposed to a control procedure. Feasibility issues include the referral/recruitment pathway, attendance, and engagement with testing and training sessions, completion of tasks, retention in the study, acceptability of outcome measures, quality of data collected (particularly, eye-tracking data). The results of the study will inform the development of a larger randomised trial.DiscussionSeveral lines of evidence emphasise the need to support emerging cognitive and learning abilities of preterm infants using early interventions. However, early interventions with preterm infants, and particularly very preterm ones, face difficulties in recruiting and retaining participants. These problems are also augmented by the health vulnerability of this population. This feasibility study will provide the basis for informing the implementation of an early cognitive intervention for very preterm infants.Trial registrationRegistered Registration ID: NCT03896490. Retrospectively registered at Clinical Trials Protocol Registration and Results System (clinicaltrials.gov).

Project description:BackgroundSeveral studies have reported the following as determining factors for the adoption of healthy lifestyles among undergraduate students: gender, socioeconomic level, prior lifestyles, environment, parental lifestyles and health status, career choice, and healthy support networks. However, these factors are influenced by students' knowledge about healthy lifestyles.Methods/designWe will carry out a randomized trial in a sample of 280 new undergraduate students at the National Autonomous University of Mexico's Faculty of Higher Studies-Zaragoza (FES-Zaragoza, UNAM). There will be an experimental group (n = 140), comprising 20 students from each of the seven university departments (careers); these students will receive training as university student health promoters through an e-learning course. This course will allow the topics necessary for such promoters to be reviewed. There will be a control group (n = 140), comprising 20 students from each of the seven departments (careers); these students will not undergo the training. Later, the students who comply satisfactorily with the e-learning course will replicate the course to 10 of their classmates. A healthy-lifestyle questionnaire will be given to all the participants, and the parameters established in the self-care card will be recorded before and after the training. The study variables are as follows: (i) independent variable-compliance with the e-learning course; (ii) dependent variables-lifestyles changes prior to the educative intervention (including healthy eating, physical activity, and addiction prevention) and parameters related to health status established in self-care (including weight, body mass index, waist circumference, and hip circumference). Data will be analyzed using Student's t test and logistic regression analysis odds ratios with 95% confidence intervals. The analysis of the open answers will be carried out with ATLAS. ti 5.5 software.DiscussionHealth promotion among university students should incorporate options that are feasible for and attractive to students. Thus, as proposed in the present protocol, e-learning courses offer excellent possibilities because they allow students to program their learning in their available time without affecting their academic studies.Trial registrationhttp://ISRCTN77787889.

Project description:BackgroundInterventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs.ObjectiveThis randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program.MethodsParticipants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed.ResultsIn the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice.ConclusionsThe program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance.ClinicaltrialClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4).

Project description:Background:Enhancing the capacity to experience positive affect could help improve recovery across a range of areas of mental health. Experimental psychopathology research indicates that a computerized cognitive training paradigm involving generation of positive mental imagery can increase state positive affect, and more recent clinical studies have suggested that this training could be used as an adjunct treatment module to target symptoms related to positive affect deficits, specifically anhedonia. The current study investigates the feasibility of adding a positive mental imagery computerized training module to treatment for patients in inpatient mental health settings, with a focus on increasing positive affect and reducing anhedonia. The positive mental imagery training (PMIT) is added to treatment as usual (TAU) in the inpatient setting, and compared to TAU alone, or TAU plus an alternative cognitive training module not hypothesized to increase positive affect, cognitive control training (CCT). Methods:The study is a feasibility randomized controlled trial with three parallel arms. Up to 90 patients admitted to inpatient mental health treatment clinics in Germany will be randomized to PMIT?+?TAU, CCT?+?TAU, or TAU on a 1:1:1 ratio. PMIT or CCT consist of an introductory session followed by up to 8 full training sessions over 2 weeks. All three arms (including TAU) include regular completion of mood measures over the 2-week period. Outcome measures are completed pre and post this 2-week training/monitoring period, and at 2-week follow-up. Data will be presented in the form of both raw means and standardized effect sizes, with 95% confidence intervals, for both intention-to-treat and per-protocol samples. Discussion:The study will inform feasibility of conducting a fully powered randomized controlled trial investigating the addition of the positive mental imagery training as a treatment adjunct to inpatient treatments for mental health, including potential refinement of study procedures, inclusion/exclusion criteria, and preliminary indications of the likely range of effect sizes. Trial registration:clinicaltrials.gov, NCT02958228 (date registered: 4 November 2016).

Project description:BACKGROUND:Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. OBJECTIVE:The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. METHODS:The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ?7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. RESULTS:Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. CONCLUSIONS:The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16799.

Dataset Information

Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial.

Publications

Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial.

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