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Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.

ABSTRACT: BACKGROUND:Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory functional capacity and quality of life across people with different chronic conditions. METHODS/DESIGN:This is a multicentre clinical trial with a type I hybrid effectiveness-implementation design, including 370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia. Patients will be randomly divided into two parallel groups, stratified by illness type. Patients in both groups will receive a standard healthy life prescription (PVS, from the Spanish "Prescribe Vida Saludable") and additionally, the EfiKroniK group will be prescribed a physical exercise programme tailored to each patient in terms of intensity in each session. The primary outcome variables will be cardiorespiratory functional capacity and quality of life. The secondary outcome variables will be signs and symptoms, psychological and social factors and specific laboratory parameters. We will also analyse the dose-response effect of the physical exercise programme. Qualitative variables will describe patients' perception of the utility and suitability of the EfiKroniK programme, as well as their expectations and satisfaction, identifying barriers to and facilitators of the EfiKroniK implementation process through discussion groups. The study will be carried out on an intention-to-treat basis, comparing changes throughout the 1-year follow-up between groups, adjusting for baseline, by performing mixed-effect analysis of covariance. We will estimate the effect of time on repeated measures in each subject and changes in the EfiKroniK and PVS groups over time. DISCUSSION:The study will provide the data necessary to allow us to prescribe physical exercise in a similar way to a drug and as a key part of the treatment of chronic illnesses within our healthcare system. TRIAL REGISTRATION:NCT03810755 . Date and version identifier: October 9, 2020. Version2.0.

SUBMITTER: Arietaleanizbeaskoa MS

PROVIDER: S-EPMC7648284 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.

Arietaleanizbeaskoa María Soledad MS Sancho Aintzane A Olazabal Iñigo I Moreno Concepcion C Gil Erreka E Garcia-Alvarez Arturo A Mendizabal Nere N de la Fuente Ibon I Dominguez Silvia S Pablo Susana S Grandes Gonzalo G

BMC family practice 20201106 1

<h4>Background</h4>Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory funct ...[more]

PMID: 33158422

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Project description:BackgroundKnee osteoarthritis (OA) is a leading cause of chronic pain and disability and one of the most common conditions treated in outpatient physical therapy (PT). Because of the high and growing prevalence of knee OA, there is a need for efficient approaches for delivering exercise-based PT to patients with knee OA. A prior randomized controlled trial (RCT) showed that a 6-session Group Physical Therapy Program for Knee OA (Group PT) yields equivalent or greater improvements in pain and functional outcomes compared with traditional individual PT, while requiring fewer clinician hours per patient to deliver. This manuscript describes the protocol for a hybrid type III effectiveness-implementation trial comparing two implementation packages to support delivery of Group PT.MethodsIn this 12-month embedded trial, a minimum of 16 Veterans Affairs Medical Centers (VAMCs) will be randomized to receive one of two implementation support packages for their Group PT programs: a standard, low-touch support based on Replicating Effective Programs (REP) versus enhanced REP (enREP), which adds tailored, high-touch support if sites do not meet Group PT adoption and sustainment benchmarks at 6 and 9 months following launch. Implementation outcomes, including penetration (primary), adoption, and fidelity, will be assessed at 6 and 12 months (primary assessment time point). Additional analyses will include patient-level effectiveness outcomes (pain, function, satisfaction) and staffing and labor costs. A robust qualitative evaluation of site implementation context and experience, as well as site-led adaptations to the Group PT program, will be conducted.DiscussionTo our knowledge, this study is the first to evaluate the impact of tailored, high-touch implementation support on implementation outcomes when compared to standardized, low-touch support for delivering a PT-based intervention. The Group PT program has strong potential to become a standard offering for PT, improving function and pain-related outcomes for patients with knee OA. Results will provide information regarding the effectiveness and value of this implementation approach and a deeper understanding of how healthcare systems can support wide-scale adoption of Group PT.Trial registrationThis study was registered on March 7, 2022 at ClinicalTrials.gov (identifier NCT05282927 ).

Project description:BackgroundThe USA is undergoing a suicide epidemic for its youngest Veterans (18-to-34-years-old) as their suicide rate has almost doubled since 2001. Veterans are at the highest risk during their first-year post-discharge, thus creating a "deadly gap." In response, the nation has developed strategies that emphasize a preventive, universal, and public health approach and embrace the value of community interventions. The three-step theory of suicide suggests that community interventions that reduce reintegration difficulties and promote connectedness for Veterans as they transition to civilian life have the greatest likelihood of reducing suicide. Recent research shows that the effectiveness of community interventions can be enhanced when augmented by volunteer and certified sponsors (1-on-1) who actively engage with Veterans, as part of the Veteran Sponsorship Initiative (VSI).Method/designThe purpose of this randomized hybrid type 2 effectiveness-implementation trial is to evaluate the implementation of the VSI in six cities in Texas in collaboration with the US Departments of Defense, Labor and Veterans Affairs, Texas government, and local stakeholders. Texas is an optimal location for this large-scale implementation as it has the second largest population of these young Veterans and is home to the largest US military installation, Fort Hood. The first aim is to determine the effectiveness of the VSI, as evidenced by measures of reintegration difficulties, health/psychological distress, VA healthcare utilization, connectedness, and suicidal risk. The second aim is to determine the feasibility and potential utility of a stakeholder-engaged plan for implementing the VSI in Texas with the intent of future expansion in more states. The evaluators will use a stepped wedge design with a sequential roll-out to participating cities over time. Participants (n=630) will be enrolled on military installations six months prior to discharge. Implementation efforts will draw upon a bundled implementation strategy that includes strategies such as ongoing training, implementation facilitation, and audit and feedback. Formative and summative evaluations will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework and will include interviews with participants and periodic reflections with key stakeholders to longitudinally identify barriers and facilitators to implementation.DiscussionThis evaluation will have important implications for the national implementation of community interventions that address the epidemic of Veteran suicide. Aligned with the Evidence Act, it is the first large-scale implementation of an evidence-based practice that conducts a thorough assessment of TSMVs during the "deadly gap."Trial registrationClinicalTrials.gov ID number: NCT05224440 . Registered on 04 February 2022.

Project description:BackgroundDisparities in posthospitalization outcomes for people with chronic medical conditions and insured by Medicaid are well documented, yet interventions that mitigate them are lacking. Prevailing transitional care interventions narrowly target people aged 65 years and older, with specific disease processes, or limitedly focus on individual-level behavioral change such as self-care or symptom management, thus failing to adequately provide a holistic approach to ensure an optimal posthospital care continuum. This study evaluates the implementation of THRIVE-an evidence-based, equity-focused clinical pathway that supports Medicaid-insured individuals with multiple chronic conditions transitioning from hospital to home by focusing on the social determinants of health and systemic and structural barriers in health care delivery. THRIVE services include coordinating care, standardizing interdisciplinary communication, and addressing unmet clinical and social needs following hospital discharge.ObjectiveThe study's objectives are to (1) examine referral patterns, 30-day readmission, and emergency department use for participants who receive THRIVE support services compared to those receiving usual care and (2) evaluate the implementation of the THRIVE clinical pathway, including fidelity, feasibility, appropriateness, and acceptability.MethodsWe will perform a sequential randomized rollout of THRIVE to case managers at the study hospital in 3 steps (4 in the first group, 4 in the second, and 5 in the third), and data collection will occur over 18 months. Inclusion criteria for THRIVE participation include (1) being Medicaid insured, dually enrolled in Medicaid and Medicare, or Medicaid eligible; (2) residing in Philadelphia; (3) having experienced a hospitalization at the study hospital for more than 24 hours with a planned discharge to home; (4) agreeing to home care at partner home care settings; and (5) being aged 18 years or older. Qualitative data will include interviews with clinicians involved in THRIVE, and quantitative data on health service use (ie, 30-day readmission, emergency department use, and primary and specialty care) will be derived from the electronic health record.ResultsThis project was funded in January 2023 and approved by the institutional review board on March 10, 2023. Data collection will occur from March 2023 to July 2024. Results are expected to be published in 2025.ConclusionsThe THRIVE clinical pathway aims to reduce disparities and improve postdischarge care transitions for Medicaid-insured patients through a system-level intervention that is acceptable for THRIVE participants, clinicians, and their teams in hospitals and home care settings. By using our equity-focused case management services and leveraging the power of the electronic medical record, THRIVE creates efficiencies by identifying high-need patients, improving communication across acute and community-based sectors, and driving evidence-based care coordination. This study will add important findings about how the infusion of equity-focused principles in the design and evaluation of evidence-based interventions contributes to both implementation and effectiveness outcomes.International registered report identifier (irrid)DERR1-10.2196/54211.Trial registrationClinicalTrials.gov NCT05714605; https://clinicaltrials.gov/ct2/show/NCT05714605.

Project description:IntroductionPhysical inactivity is the fourth leading risk factor for global mortality, and inactive adults have a higher risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy of fitness technologies and other digital interventions for physical activity (PA) promotion. Intervention studies are needed to test the effectiveness and implementation of innovative PA promotion strategies.Methods and analysisThe ONWARDS study is a hybrid type I effectiveness-implementation randomized control trial aiming at an inactive and presumably high-risk population living in Northern Norway. One hundred and eighty participants will be assigned to 3 groups in a 1:1:1 ratio and participate for 18 months. Participants in group A will be provided an activity tracker with the personalized metric Personal Activity Intelligence (PAI). Participants in group B will be provided with both an activity tracker with the personalized metric PAI and access to online training videos (Les Mills+) to perform home-based training. Participants in group C will be provided an activity tracker with the personalized metric PAI, home-based online training and additional peer support via social media. The primary objective is to test which combination of interventions is more effective in increasing PA levels and sustaining long-term exercise adherence. Secondary objectives include: proportion of participants reaching PA recommendations; exercise adherence; physical fitness; cardiovascular risk; quality of life; perceived competence for exercise; self-efficacy; social support; usability; users' perspectives on implementation outcomes (adoption, acceptability, adherence, sustainability). The study design will allow testing the effectiveness of the interventions while gathering information on implementation in a real-world situation.DiscussionThis study can contribute to reduce disparities in PA levels among inactive adults by promoting PA and long-term adherence. Increased PA might, in turn, result in better prevention of lifestyle diseases. Digital interventions delivered at home can become an alternative to training facilities, making PA accessible and feasible for inactive populations and overcoming known barriers to PA. If effective, such interventions could potentially be offered through national health portals to citizens who do not meet the minimum recommendations on PA or prescribed by general practitioners or specialists.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04526444, Registered 23 April 2021, identifier: NCT04526444.

Project description:IntroductionCancer care has expanded from a disease-focused, survival-oriented model to an approach that now considers how survivors can live well in the aftermath of intensive therapy, where they may deal with significant changes to their bodies, mental health or emotional well-being. Research evidence supports the benefit of exercise during and following cancer treatments for cancer-related symptoms, physical functioning and fitness, and health-related quality of life. To move this efficacy evidence into practice, we designed and launched a 5-year study to evaluate the relative benefit from implementing a clinic-to-community-based cancer and exercise model of care.Methods and analysisA hybrid effectiveness and implementation trial design is being used to evaluate the effectiveness of delivery of community-based exercise and to collect data on implementation of the programme. The study opened in January 2017, with estimated completion by January 2022. The programme will be delivered in seven cities across the province of Alberta, Canada, with sites including three academic institutions, six YMCA locations, Wellspring Edmonton and Calgary, and six municipal fitness centres. Participants are adult cancer survivors (n=2500) from all tumour groups and stages and at any time point along their cancer treatment trajectory, up to 3 years post treatment completion. Survivors take part in a minimum of 60 min of mild-to-moderate intensity full body exercise twice weekly for a 12-week period. The primary effectiveness outcome is the proportion of participants meeting or exceeding 150 min of moderate intensity exercise per week at 1-year follow-up. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be utilised to capture individual-level and organizational-level impact of the exercise programme at 12 and 24 weeks and 1-year follow-up. The cohort of survivors participating in the study will allow for long-term (>5-year) evaluation of rates of cancer recurrence and secondary cancers beyond the funding period.Ethics and disseminationThe study was approved by the Health Research Ethics Board of Alberta. The study is funded by Alberta Innovates and the Alberta Cancer Foundation. The study will help to answer critical questions on the effectiveness of cancer-specific community-based exercise programming in both the short-term and the long-term. Collectively, the findings will help to inform the acceptability, adoption, feasibility, reach and sustainability of community-based exercise.Trial registration numberNCT02984163; Pre-results.

Project description:BackgroundMultimorbidity is a major problem in Europe, increasing the need for prevention and rehabilitation programs. In Germany no guidelines have been developed that focus on patients with multiple chronic non-communicable diseases (NCDs). Benefits of physical activity (PA) and exercise in NCDs have been proven, but most interventions focus on single conditions. The evaluation of the effectiveness, efficiency and safety of PA programs in patients suffering from multiple NCDs and the feasibility of the implementation within the health care service remain open research questions.MethodsThe multi-site randomized controlled pragmatic trial includes 320 sedentary subjects with at least two of the following NCDs, either manifested or in a pre-stage with evident risk factors: Cardio-vascular disease, Diabetes mellitus type 2, knee/ hip osteoarthritis and obesity. Participants will be recruited from general practitioners and medical specialists and randomized to standard care of a statutory health insurance or MultiPill-Exercise. Standard care includes a choice of one or a maximum of two 8- to 12-week health programs, including nutrition, exercise, relaxation or special disease management programs. MultiPill-Exercise is based on the bio-psycho-social health model, considering a person-oriented perspective in light of given individual characteristics and context factors. The 24-weeks intervention focuses on aerobic and strengthening exercises in line with the WHO PA recommendations. Psychological and pedagogical elements along with behavior change techniques are implemented to ease the initiation and maintenance of exercise participation and lifestyle change, including nutrition. Primary outcome will be short- and long-term PA measured with the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ). Secondly, the effectiveness of the program on generic, disease specific, economic, and exercise behavioral parameters, as well as program adherence and safety will be evaluated.DiscussionResults of this trial evaluate the PA intervention program in people with multiple NCDs in a real-life scenario. It will serve as a proof of concept with the opportunity of translation into routine practice. This approach, as a multi-site RCT with its rigorous methods and standardized operating procedures for the conduction of the intervention, will allow valid conclusions for the implementation of PA interventions in people with multimorbidity.Trial registrationThe trial was registered at www.drks.de (ID: DRKS00025033 ) on 30th September 2021.

Project description:The number of children diagnosed with autism has rapidly outpaced the capacities of many public school systems to serve them, especially under-resourced, urban school districts. The intensive nature of evidence-based autism interventions, which rely heavily on one-to-one delivery, has caused schools to turn to computer-assisted interventions (CAI). There is little evidence regarding the feasibility, effectiveness, and implementation of CAI in public schools. While CAI has the potential to increase instructional time for students with autism, it may also result in unintended consequences such as reduction in the amount of interpersonal (as opposed to computerized) instruction students receive. The purpose of this study is to test the effectiveness of one such CAI-TeachTown-its implementation, and its effects on teachers' use of other evidence-based practices.This study protocol describes a type II hybrid cluster randomized effectiveness-implementation trial. We will train and coach 70 teachers in autism support classrooms in one large school district in the use of evidence-based practices for students with autism. Half of the teachers then will be randomly selected to receive training and access to TeachTown: Basics, a CAI for students with autism, for the students in their classrooms. The study examines: (1) the effectiveness of TeachTown for students with autism; (2) the extent to which teachers implement TeachTown the way it was designed (i.e., fidelity); and (3) whether its uptake increases or reduces the use of other evidence-based practices.This study will examine the implementation of new technology for children with ASD in public schools and will be the first to measure the effectiveness of CAI. As importantly, the study will investigate whether adding a new technology on top of existing practices increases or decreases their use. This study presents a unique method to studying both the implementation and exnovation of evidence-based practices for children with autism in school settings.NCT02695693 . Retrospectively registered on July 8, 2016.

Project description:BackgroundPhysical inactivity is a leading risk factor for chronic disease. Brief physical activity counselling delivered within healthcare systems has been shown to increase physical activity levels; however, implementation efforts have mostly targeted primary healthcare and uptake has been sub-optimal. The Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR) trial aims to address this evidence-practice gap by evaluating (i) the effectiveness of a multi-faceted implementation strategy, relative to usual practice for improving the proportion of patients receiving brief physical activity counselling as part of their routine hospital-based physiotherapy care and (ii) effectiveness of brief physical activity counselling embedded in routine physiotherapy care, relative to routine physiotherapy care, at improving physical activity levels among patients receiving physiotherapy care.MethodsEffectiveness-implementation hybrid type II cluster randomised controlled trial with embedded economic evaluation, qualitative study and culturally adapted patient-level outcome measures. The trial will be conducted across five hospitals in a local health district in Sydney, Australia, with a lower socioeconomic and culturally diverse population. The evidence-based intervention is brief physical activity counselling informed by the 5As counselling model and behavioural theory, embedded into routine physiotherapy care. The multi-faceted strategy to support the implementation of the counselling intervention was developed with key stakeholders guided by the Consolidated Framework for Implementation Research and the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model, and consists of clinician education and training, creating a learning collaborative, tailored strategies to address community referral barriers, team facilitation, and audit and feedback. Thirty teams of physiotherapists will be randomised to receive the multi-faceted implementation strategy immediately or after a 9-month delay. Each physiotherapy team will recruit an average of 10 patients (n=300) to collect effectiveness outcomes at baseline and 6 months. The primary effectiveness outcome is self-reported planned physical activity using the Incidental and Planned Exercise Questionnaire, and the primary implementation outcome is reach (proportion of eligible new physiotherapy patients who receive brief physical activity counselling). Secondary effectiveness and implementation outcomes will also be collected.DiscussionThis project focuses on physiotherapists as health professionals with the requisite skills and patterns of practice to tackle the increasing burden of chronic disease in a high-risk population.Trial registrationANZCTR, ACTRN12621000194864 . Registered on 23 February 2021.

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Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.

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Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.

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