Dataset Information

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial.

ABSTRACT: Sedentariness of patients affected by end-stage kidney disease (ESKD) expose them to high risk of unfavorable clinical outcomes. Exercise training is effective in improving physical function, quality of life (QoL) and long-term outcomes. However, the existing barriers related to patients, programs and dialysis staff limit patient participation and call for new strategies. This pragmatic nonrandomized trial will test the impact on ESKD population of an intervention proposed by an exercise facilitator regularly present in a dialysis center. The patient will be free to choose among three-month walking and/or resistance low-intensity training programs: (a) guided physical activity increase; (b) home-based exercise; (c) in-hospital (pre/post dialysis) supervised exercise; (d) performance assessment only. The first phase will define feasibility and the characteristics and preference of responders. The second phase will evaluate safety and patients' adherence. Outcome measures will be collected at baseline, after three-month and at six-month follow-up. They will include: aerobic capacity, QoL, gait speed, strength, depression and long-term clinical outcomes (hospitalization and mortality). The trial was approved by the Area-Vasta Emilia-Romagna Centro Ethics Committee with approval number 48/2019. Written informed consent will be obtained from all participants. The results of the study will be presented in international congresses, published in peer-reviewed journals and communicated to the patient community. Registration details: Clinicaltrials.gov NCT04282616 [Registered:24/02/2020].

SUBMITTER: Manfredini F

PROVIDER: S-EPMC7768449 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial.

Manfredini Fabio F Lamberti Nicola N Battaglia Yuri Y Straudi Sofia S Belvederi Murri Martino M Donadi Maria M Piva Giovanni G Fabbian Fabio F López-Soto Pablo Jesús PJ Grassi Luigi L Manfredini Roberto R Basaglia Nino N Storari Alda A

Methods and protocols 20201206 4

Sedentariness of patients affected by end-stage kidney disease (ESKD) expose them to high risk of unfavorable clinical outcomes. Exercise training is effective in improving physical function, quality of life (QoL) and long-term outcomes. However, the existing barriers related to patients, programs and dialysis staff limit patient participation and call for new strategies. This pragmatic nonrandomized trial will test the impact on ESKD population of an intervention proposed by an exercise facilit ...[more]

PMID: 33470990

Similar Datasets

Project description:BackgroundDespite the acceptability and efficacy of e-patient-reported outcome (ePRO) systems, implementation in routine clinical care remains challenging.ObjectiveThis pragmatic trial implemented the PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care) web-based system into existing clinical workflows and evaluated its effectiveness among a diverse population of patients with cancer.MethodsAdult patients with solid tumors receiving active treatment or follow-up care in four cancer centers were enrolled. The PROMPT-Care intervention supported patient management through (1) monthly off-site electronic PRO physical symptom and psychosocial well-being assessments, (2) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and (3) tailored online patient self-management resources. Propensity score matching was used to match controls with intervention patients in a 4:1 ratio for patient age, sex, and treatment status. The primary outcome was a reduction in emergency department presentations. Secondary outcomes were time spent on chemotherapy and the number of allied health service referrals.ResultsFrom April 2016 to October 2018, 328 patients from four public hospitals received the intervention. Matched controls (n=1312) comprised the general population of patients with cancer, seen at the participating hospitals during the study period. Emergency department visits were significantly reduced by 33% (P=.02) among patients receiving the intervention compared with patients in the matched controls. No significant associations were found in allied health referrals or time to end of chemotherapy. At baseline, the most common patient reported outcomes (above-threshold) were fatigue (39%), tiredness (38.4%), worry (32.9%), general wellbeing (32.9%), and sleep (24.1%), aligning with the most frequently accessed self-management domain pages of physical well-being (36%) and emotional well-being (23%). The majority of clinical feedback reports were reviewed by nursing staff (729/893, 82%), largely in response to the automated clinical alerts (n=877).ConclusionsAlgorithm-supported web-based systems utilizing patient reported outcomes in clinical practice reduced emergency department presentations among a diverse population of patients with cancer. This study also highlighted the importance of (1) automated triggers for reviewing above-threshold results in patient reports, rather than passive manual review of patient records; (2) the instrumental role nurses play in managing alerts; and (3) providing patients with resources to support guided self-management, where appropriate. Together, these factors will inform the integration of web-based PRO systems into future models of routine cancer care.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000615482; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370633.International registered report identifier (irrid)RR2-10.1186/s12885-018-4729-3.

Project description:BackgroundOne of the greatest barriers found by physical therapy treating individuals with Parkinson's disease (PD) is the adherence to treatment, associated with the lack of motivation to remain active. Therefore, there is a need to change the look given to physical therapy and for the individual, seeking the centralization of the therapy in their preferences. This study aims to present the EMPOWER-PD, a protocol based on individual preferences and its design for feasibility.MethodA 12-week pilot for a randomized clinical trial will assess the feasibility and preliminary effectiveness of the EMPOWER-PD and make comparisons with conventional physical therapy (CPh). Both protocols consist of mobility and locomotion training, and aim at improving motor and non-motor symptoms through different approaches. The EMPOWER-PD aims to provide a source of motivation and empowerment of health through the self-knowledge of the individual's abilities and limitations, in a protocol that addresses individual preferences. The CPh is based only on physiotherapist decisions, not addressing the individual's preferences or motivation/empowerment. The target recruitment will be 24 PD individuals, between stages I and III of Hoehn and Yahr (HY), who will be recruited from Brazilian Parkinson's disease Rehabilitation Initiative (BPaRkI) with allocation ratio 1:1. A computerized block randomization procedure will be implemented by a blinded researcher with the participants blinded to group assignment. The sessions will be conducted in a group setting, twice a week, during 60 min for 8 weeks, followed by 4 weeks of follow-up. The primary outcomes will be the feasibility data (adherence, recruitment rate, and safety). The secondary outcomes will assess the preliminary efficacy on qualitative assessment about individual's motivation/empowerment and quantitative motor outcomes (Timed Up and Go and Dynamic Gait Index) and non-motor symptoms (6-min walk test and Fatigue Severity Scale). The recommendation to have 6-12 participants per group will be adopted based on the qualitative analysis to the sample size.DiscussionThis study will provide important insights about the physical therapy approach in PD individuals. The EMPOWER-PD is innovative because (1) it proposes an intervention that includes an individual-centered approach with motor control principles; (2) it aims to provide a source of motivation and empowerment of health; (3) assesses the individual in a global view considering motor and non-motor symptoms, using both, qualitative and quantitative metrics.Trial registrationRBR-7ZBXQ5.

Project description:IntroductionThere is growing interest in delivering patient-centered care in all areas of medical practice, yet acquiring the requisite attitudes, skills, and behaviors simply by observing or participating in current systems of care that employ a medical or physician-centric model is challenging. Patient centeredness involves an understanding of patients' perspectives on their illness and treatment, the impact that health and illness have on the lives of patients, and the values and goals patients have for themselves, while also encouraging patients and health care professionals to engage in a shared decision-making model of health care. That model aspires to result in increased trust between providers and patients, as well as better patient outcomes.MethodsThis 90-minute workshop utilizes three different approaches to help the learner develop patient-centered care and communication skills in a mental health setting: a video of a patient sharing her experience with the mental health system, a narrative model of appreciating patient experience (first-person memoir), and an exercise using patient-centered language in a medical record documentation.ResultsThis workshop was presented at the American Association of Psychiatric Directors of Residency Training (AADPRT) Annual Meeting in March 2016. Approximately 21 people attended. Feedback was received from 11 participants and demonstrated a high degree of agreement (4.5 out of 5) with the following statements: the speakers met the stated educational objectives; the content was educationally useful; the information in this presentation will inform my educational practices; the presentation advanced my knowledge of the subject.DiscussionWhile these three pedagogical exercises do not cover the entirety of the skills required for patient-centered care and communication, they do provide a useful starting point for hearing and appreciating the experience of the patient. Despite the focus on mental health settings and treatment, other medical specialties could derive useful ideas from this workshop format or adapt the materials to their own needs.

Project description:BackgroundPatients on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Several small studies have reported efficacy of diverse exercise interventions among persons with CKD and those on dialysis. However, no single intervention has been widely adopted in real-world practice, despite a clear need in this vulnerable population with high rates of mortality, frailty, and skilled nursing hospitalizations.Methods/designWe describe a pragmatic clinical trial for an exercise intervention among patients transitioning to dialysis. We will use an existing framework - Exercise is Medicine (EIM) - developed by the American College of Sports Medicine. After undertaking formative qualitative research to tailor the EIM framework to the advanced CKD population (eGFR < 30 ml/min/1.73m2), we will randomize 96 patients from two regions-Atlanta and Bay Area-in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education, and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8-week follow up). We will assess efficacy by comparing between group differences in minutes/week of objectively measured moderate intensity physical activity. To evaluate implementation, we will use questionnaires for assessing barriers to referral, participation and retention along the path of the intervention. Further we will have a plan for dissemination of the intervention by partnering with relevant stakeholders.DiscussionThe overall goal is to inform the development of a practical, cost-conscious intervention "package" that addresses barriers and challenges to physical activity commonly faced by patients with advanced CKD and can be disseminated amongst interested practices.Trial registrationClinicalTrials.gov identifier (Dated:10/17/2017): NCT03311763 .

Project description:ImportanceFalls represent a leading cause of preventable injury in hospitals and a frequently reported serious adverse event. Hospitalization is associated with an increased risk for falls and serious injuries including hip fractures, subdural hematomas, or even death. Multifactorial strategies have been shown to reduce falls in acute care hospitals, but evidence for fall-related injury prevention in hospitals is lacking.ObjectiveTo assess whether a fall-prevention tool kit that engages patients and families in the fall-prevention process throughout hospitalization is associated with reduced falls and injurious falls.Design, setting, and participantsThis nonrandomized controlled trial using stepped wedge design was conducted between November 1, 2015, and October 31, 2018, in 14 medical units within 3 academic medical centers in Boston and New York City. All adult inpatients hospitalized in participating units were included in the analysis.InterventionsA nurse-led fall-prevention tool kit linking evidence-based preventive interventions to patient-specific fall risk factors and designed to integrate continuous patient and family engagement in the fall-prevention process.Main outcomes and measuresThe primary outcome was the rate of patient falls per 1000 patient-days in targeted units during the study period. The secondary outcome was the rate of falls with injury per 1000 patient-days.ResultsDuring the interrupted time series, 37 231 patients were evaluated, including 17 948 before the intervention (mean [SD] age, 60.56 [18.30] years; 9723 [54.17%] women) and 19 283 after the intervention (mean [SD] age, 60.92 [18.10] years; 10 325 [53.54%] women). There was an overall adjusted 15% reduction in falls after implementation of the fall-prevention tool kit compared with before implementation (2.92 vs 2.49 falls per 1000 patient-days [95% CI, 2.06-3.00 falls per 1000 patient-days]; adjusted rate ratio 0.85; 95% CI, 0.75-0.96; P = .01) and an adjusted 34% reduction in injurious falls (0.73 vs 0.48 injurious falls per 1000 patient-days [95% CI, 0.34-0.70 injurious falls per 1000 patient-days]; adjusted rate ratio, 0.66; 95% CI, 0.53-0.88; P = .003).Conclusions and relevanceIn this nonrandomized controlled trial, implementation of a fall-prevention tool kit was associated with a significant reduction in falls and related injuries. A patient-care team partnership appears to be beneficial for prevention of falls and fall-related injuries.Trial registrationClinicalTrials.gov Identifier: NCT02969343.

Dataset Information

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial.

Publications

A Personalized Patient-Centered Intervention to Empower through Physical Activity the Patient in the Dialysis Center: Study Protocol for a Pragmatic Nonrandomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets