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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：
10402923
负责人：
Cory L Christiansen
金额：
$ 38.54万
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 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10402923
关键词：
Address Adoption Ambulatory Care Amputation Behavior Caring Chronic Chronic Disease Clinical Clinical Research Complex Control Groups Deltastab 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 Randomized Controlled Trials 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 arm attentional control base biobehavior clinical implementation comorbidity 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.

项目概要/摘要该研究的最终目标是优化人们的生活质量并尽量减少残疾通过改善体力活动自我管理来治疗血管障碍性下肢截肢。一个初始的实现这一目标的一步是测试我们的步行生物行为干预。我们的总体假设是对血管不良下肢截肢康复者实施步行生物行为干预，一种以多种慢性病为特征的疾病，将改善健康自我管理，衡量标准为增加习惯性体力活动。血管障碍性截肢的复杂性和共病性需要与创伤性截肢相比，愈合时间更长，恢复方法独特。截肢前存在的慢性久坐行为在加上以下因素后会变得更加明显：肢体丧失的影响。因此，患有血管障碍性截肢的人报告了极高的残疾率和步行限制是他们的首要功能问题。生物行为干预融入传统的假肢康复是通过利用改变的动机。然而，假肢训练指南不包括步行生物行为干涉。因此，本次二期临床试验的目的是：1）测试步行的益处用于改善习惯性日常步行活动的生物行为干预，以及 2) 确定潜力通过执行初始步骤来实施康复中的步行生物行为干预评估干预措施的范围、功效、采用、实施和维持。本次审判提出了一种替代策略，可在服务不足、医疗条件较差的地区改善生活质量并减少残疾复杂的慢性疾病人群。该试验与 NIH 资助机会直接相关 PA-18-146 公告，寻求有关自我管理干预措施的临床研究，以改善需要帮助以优化功能、预防/延迟残疾以及应对其困难的人的生活质量环境。