Improving health self-management using walking biobehavioral intervention for people with dysvascular lower limb amputation

通过步行生物行为干预改善下肢血管障碍截肢患者的健康自我管理

基本信息

批准号：
10614536
负责人：
Cory L Christiansen
金额：
$ 38.51万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10614536
关键词：
2 arm randomized control trial Address Adoption Ambulatory Care Amputation Behavior Caring Chronic Chronic Disease Clinical Clinical Research Complex Control Groups Diabetes Mellitus Disabled Persons Disease Early Intervention Enrollment Environment Evaluation Focus Groups Funding Opportunities Futility Future Goals Guidelines Health Intervention Learning Lower Extremity Maintenance Measures Medical Methods Monitor Motivation Nature Outcome Participant Patient Recruitments Patients Peripheral arterial disease Persons Phase Phase II Clinical Trials Physical Function Physical activity Population Prosthesis Prosthetic rehabilitation Quality of life Questionnaires Reach, Effectiveness, Adoption, Implementation, and Maintenance Recovery Rehabilitation therapy Reporting Research Research Design Role Schedule Self Efficacy Self Management Site Testing Time Training Traumatic Amputation Treatment Efficacy United States National Institutes of Health Walking Work World Health Organization attentional control biobehavior clinical implementation comorbidity comparison control design disability eligible participant evidence base healing implementation design implementation evaluation improved limb amputation limb loss multiple chronic conditions novel patient oriented phase III trial physical conditioning prevent primary endpoint primary outcome rural area sedentary lifestyle success telehealth underserved area wearable sensor technology

项目摘要

PROJECT SUMMARY / ABSTRACT The ultimate goal of this line of research is to optimize quality of life and minimize disability for people with dysvascular lower limb amputation through improved physical activity self-management. An initial step toward that goal is to test our walking biobehavioral intervention. Our overarching hypothesis is that implementing walking biobehavioral intervention for people recovering from dysvascular lower limb amputation, a disease characterized by multiple chronic conditions, will improve health self-management, as measured by increased habitual physical activity. The complex, comorbid nature of dysvascular amputation requires extended healing time and unique approaches to recovery compared to amputation from traumatic causes. Chronic sedentary behaviors that are present before amputation become more obvious when compounded by the effects of limb loss. As a result, people with dysvascular amputation report extremely high disability and walking limitation as their number one functional problem. Biobehavioral intervention integrated within conventional prosthesis rehabilitation is an opportune time to address walking behaviors by capitalizing on motivation for change. However, prosthetic training guidelines do not include walking biobehavioral intervention. Therefore, the purposes of this Phase II clinical trial are to: 1) test the benefit of walking biobehavioral intervention for improving habitual daily walking activity and 2) determine the potential for implementing the walking biobehavioral intervention in rehabilitation by performing initial assessments of intervention reach, efficacy, adoption, implementation, and maintenance. This trial presents an alternative strategy for improving quality of life and reducing disability in an underserved, medically complex, chronic disease population. The trial is directly aligned with the NIH Funding Opportunity Announcement PA-18-146, which seeks clinical research on self-management interventions that improve quality of life in persons needing assistance to optimize function, prevent/delay disability, and navigate their environment.

项目摘要 /摘要这一研究线的最终目标是优化生活质量并最大程度地减少人们的残疾通过改善体育活动的自我管理，血管下肢截肢。最初朝着这一目标迈进的一步是测试我们的行走生物行为干预。我们的总体假设是为从血管下肢截肢恢复的人实施步行生物行为干预措施，以多种慢性疾病为特征的疾病将改善健康自我管理，如增加习惯性体育锻炼。血管截肢的复杂，合并性质需要与创伤原因截肢相比，延长的愈合时间和独特的恢复方法。截肢之前存在的慢性久坐行为变得更加明显肢体损失的影响。结果，血管截肢的患者报告的残疾极高，步行限制是他们的第一功能问题。整合的生物行为干预传统的假体康复是通过大写来解决步行行为的合适时机变革的动力。但是，假肢培训指南不包括步行生物行为干涉。因此，该II期临床试验的目的是：1）测试步行的好处生物行为干预以改善习惯性每日步行活动，2）确定潜力通过执行初始评估干预措施，疗效，采用，实施和维护。这个试验提出了改善生活质量和减少服务不足，医学上的残疾的替代策略复杂的慢性疾病人群。试验与NIH资助机会直接保持一致公告PA-18-146，正在寻求有关改善自我管理干预措施的临床研究需要协助以优化功能，预防/延迟残疾的人的生活质量环境。