Dataset Information

Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs. OBJECTIVE:The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs. METHODS:The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants' PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months. RESULTS:Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities. CONCLUSIONS:We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs. TRIAL REGISTRATION:ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/19213.

SUBMITTER: Michalsen H

PROVIDER: S-EPMC7367531 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial.

Michalsen Henriette H Wangberg Silje Camilla SC Hartvigsen Gunnar G Jaccheri Letizia L Muzny Miroslav M Henriksen André A Olsen Monica Isabel MI Thrane Gyrd G Jahnsen Reidun Birgitta RB Pettersen Gunn G Arntzen Cathrine C Anke Audny A

JMIR research protocols 20200629 6

<h4>Background</h4>Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA ...[more]

PMID: 32437328

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Project description:BACKGROUND:New Zealand urgently requires scalable, effective, behavior change programs to support healthy lifestyles that are tailored to the needs and lived contexts of M?ori and Pasifika communities. OBJECTIVE:The primary objective of this study is to determine the effects of a co-designed, culturally tailored, lifestyle support mHealth tool (the OL@-OR@ mobile phone app and website) on key risk factors and behaviors associated with an increased risk of noncommunicable disease (diet, physical activity, smoking, and alcohol consumption) compared with a control condition. METHODS:A 12-week, community-based, two-arm, cluster-randomized controlled trial will be conducted across New Zealand from January to December 2018. Participants (target N=1280; 64 clusters: 32 M?ori, 32 Pasifika; 32 clusters per arm; 20 participants per cluster) will be individuals aged ?18 years who identify with either M?ori or Pasifika ethnicity, live in New Zealand, are interested in improving their health and wellbeing or making lifestyle changes, and have regular access to a mobile phone, tablet, laptop, or computer and to the internet. Clusters will be identified by community coordinators and randomly assigned (1:1 ratio) to either the full OL@-OR@ tool or a control version of the app (data collection only plus a weekly notification), stratified by geographic location (Auckland or Waikato) for Pasifika clusters and by region (rural, urban, or provincial) for M?ori clusters. All participants will provide self-reported data at baseline and at 4- and 12-weeks postrandomization. The primary outcome is adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score at 12 weeks that assesses smoking behavior, fruit and vegetable intake, alcohol intake, and physical activity. Secondary outcomes include self-reported body weight, holistic health and wellbeing status, medication use, and recorded engagement with the OL@-OR@ tool. RESULTS:Trial recruitment opened in January 2018 and will close in July 2018. Trial findings are expected to be available early in 2019. CONCLUSIONS:Currently, there are no scalable, evidence-based tools to support M?ori or Pasifika individuals who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster-randomized trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool in supporting healthy lifestyles. TRIAL REGISTRATION:Australia New Zealand Clinical Trials Register ACTRN12617001484336; http://www.ANZCTR.org.au/ACTRN12617001484336.aspx (Archived by WebCite at http://www.webcitation.org/71DX9BsJb). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10789.

Project description:BACKGROUND:Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown. OBJECTIVE:The aim of this study is to determine the marginal effects of a financial incentive-based intervention on inhaled corticosteroid adherence, health care system use, and costs. METHODS:Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain-framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent. RESULTS:Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023. CONCLUSIONS:This study will provide data that will help to determine whether a financial incentive-based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods. TRIAL REGISTRATION:Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16711.

Project description:BackgroundFamily carers play a crucial role in supporting the health and well-being of people with intellectual disabilities. Given their role and responsibilities, many family carers experience significant and ongoing stress and mental health difficulties. Programmes and interventions which provide training and support to family carers have been shown to have a positive impact on levels of stress and quality of life. However, these are often face to face which can create barriers to full participation. Online interventions have been shown to offer flexibility in delivery compared with traditional face-to-face approaches. The primary objective of this study is to determine the feasibility of delivering the Carers-ID online intervention, while the secondary outcome is improved mental health in family carers of people with intellectual disabilities.MethodsFamily carers (n = 120) will be randomised to receive the intervention (n = 60) or assigned to a wait-list control (n = 60) group. The intervention ( www.Carers-ID.com ) consists of 14 modules which cover topics including the following: promoting resilience, providing peer support, reducing anxiety, managing stress, accessing local supports and managing family conflict and information for siblings who are carers. The intervention has been co-produced with voluntary sector organisations and family carers and tested for acceptability. Primary outcomes for this study include acceptability and feasibility of the outcome measures, recruitment, participation and retention rates and effect sizes. Secondary outcomes will be completed at three time points (baseline, following intervention completion and 3 months after completion). These include the following: the Depression, Anxiety and Stress Scale, the Warwick-Edinburgh Mental Well-being Scale, the Resilience Scale and the Social Connectedness Scale Revised. Participants (n = 12) who have taken part in the intervention arm of the research will be invited to participate in semi-structured interviews as part of the process evaluation.DiscussionThe Carers-ID intervention provides an online resource for family carers to support their mental health and well-being and promote their resilience. It represents an affordable and accessible means of delivering such support. Testing the feasibility of the intervention and related trial procedures is required to determine whether a full-scale randomised controlled trial to evaluate the intervention's effectiveness is warranted.Trial registrationClinicalTrials.gov : NCT05737823.

Project description:BackgroundHealth care is shifting toward a more person-centered model; however, people with intellectual and developmental disabilities can still experience difficulties in accessing equitable health care. Given these difficulties, it is important to consider how humanizing principles, such as empathy and respect, can be best incorporated into health and social care practices for people with intellectual and developmental disabilities to ensure that they are receiving equitable treatment and support.ObjectiveThe purpose of our scoping review is to provide an overview of the current research landscape and knowledge gaps regarding the development and implementation of interventions based on humanizing principles that aim to improve health and social care practices for people with intellectual and developmental disabilities.MethodsThe PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) and PICOS (Population, Intervention, Comparator, Outcome, and Study) frameworks will be used to structure the review. A total of 6 databases (PubMed, MEDLINE, Embase, CINAHL, PsycINFO, and Web of Science) will be searched for English articles published in the previous 10 years that describe or evaluate health and social care practice interventions underpinned by the humanizing principles of empathy, compassion, dignity, and respect. Two reviewers will screen and select references based on the eligibility criteria and extract the data into a predetermined form. A descriptive analysis will be conducted to summarize the results and provide an overview of interventions in the following three main care areas: health care, social care, and informal social support.ResultsThe results will be included in the scoping review, which is expected to begin in October 2022 and be completed and submitted for publication by January 2023.ConclusionsOur scoping review will summarize the state of the field of interventions that are using humanizing principles to improve health and social care for adults with intellectual and developmental disabilities.International registered report identifier (irrid)PRR1-10.2196/31720.

Project description:BackgroundDiabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature.ObjectiveThe aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention-artificial intelligence for diabetes management (AI4DM)-which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research.MethodsWe have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC-focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior.ResultsEnrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022.ConclusionsDeveloping and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research.Trial registrationClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377.International registered report identifier (irrid)PRR1-10.2196/31695.

Project description:BackgroundIndividuals with disabilities are typically more sedentary and less fit compared to their peers without disabilities. Furthermore, engaging in physical activity can be extremely challenging due to physical impairments associated with disability and fewer opportunities to participate. One option for increasing physical activity is playing active video games (AVG), a category of video games that requires much more body movement for successful play than conventional push-button or joystick actions. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in physical activity.ObjectiveOur aim was to compare the effect of off-the-shelf and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with physical disabilities, specifically those with mobility impairments (ie, unable to stand, balance issues, poor motor control, unable to use lower extremity for gameplay). The gaming controllers to be evaluated include off-the-shelf and adapted versions of the Wii Fit balance board and gaming mat.MethodsParticipants (10-60 years old) came to the laboratory a total of three times. During the first visit, participants completed a functional assessment and became familiar with the equipment and games to be played. For the functional assessment, participants performed 18 functional movement tasks from the International Classification of Functioning, Disability, and Health. They also answered a series of questions from the Patient Reported Outcomes Measurement Information System and Quality of Life in Neurological Conditions measurement tools, to provide a personal perspective regarding their own functional ability. For Visit 2, metabolic data were collected during an initial 20-minute baseline, followed by 40 minutes of game play. The controller (balance board or gaming mat) played was randomly selected. A set of games was played for 10 minutes, followed by 5 minutes of rest, and then another set of games was played for 10 minutes, followed by rest. Quality of game play was observed and documented for each set. During rest, the participant completed questions regarding enjoyment. Following the same procedures, the participant then played the two sets of games using the other version (off-the-shelf or adapted) of the controller. The entire procedure was repeated during Visit 3 with the controller that was not played.ResultsEnrollment began in February 2016 and ended in September 2016. Study results will be reported in late 2017.ConclusionsWe hypothesized that the adapted versions of the Wii Fit balance board and gaming mat would produce greater quality of game play, enjoyment, and energy expenditure in persons with mobility impairments compared to off-the-shelf versions.Trial registrationClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6qpPszPJ7).

Dataset Information

Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial.

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Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial.

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