跳至主要内容
临床试验/NCT04335695
NCT04335695终止不适用

Standardized Vascular Rehabilitation Program to Improve Patient Disease and Quality of Life

Baylor Research Institute2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
2
主要终点
Changes to quality of life surveys at VRP enrollment, VRP discharge, and one year after discharge. Range 7-175

研究概览

简要总结

The purpose of this study is to identify the type of patients being referred for the Vascular Rehabilitation Program (VRP) and to study the success rates of the program according to improvements in walking distance and quality of life surveys. Subjects will be in the VRP for 6-12 weeks and then be followed for 12 months after they complete the program. This is a single-site study at Baylor Scott & White Heart Hospital-Plano.

详细描述

Peripheral arterial occlusive disease (PAOD) affects 8.5 million people in the United States. One of the most common symptoms of PAOD is claudication. While there are surgical and endovascular treatments to address the underlying arterial occlusions and relieve patients from their symptoms, the initial and primary treatment of vasculogenic claudication is exercise. Numerous studies have documented the success rates of conservative management in the short and long term. However, the main barriers to the use and success of this treatment have been physician reluctance to prescribe and supervise and lack of enthusiasm by the patients. Furthermore, unlike cardiac rehabilitation, supervised rehabilitation and therapy was not a covered benefit for patients until recently.

Beginning in 2018, Centers for Medicare Services (CMS) mandated coverage for supervised therapy for vasculogenic claudication. In 2019, a vascular rehabilitation program was established at The Heart Hospital Plano. As healthcare moves from a fee-for-service model to a payment-for-quality model, treatments such as this are becoming more important. It is necessary to have a better understanding of qualifying patients, the success of this treatment, and the durability and risk factors for success and failure in the real world outside of randomized trials.

This will be the first study of vascular rehabilitation as therapy for vasculogenic claudication in the community setting since this benefit was approved by CMS. It will integrate the areas of Vascular Surgery, Cardiology, Nursing and Cardiac Rehabilitation into a single collaborative project. The project also nicely aligns with the Baylor Scott&White Healthcare System goal of population management in evaluating this lifestyle treatment as an alternative to intervention.

This is a prospective, non-randomized, observational study designed to demonstrate clinically significant benefit in patients undergoing the vascular rehabilitation program at The Heart Hospital Plano.

Informed consent will be obtained from all patients who wish to be enrolled in the study and will be asked to complete quality-of-life surveys specific for vasculogenic claudication (VascuQoL [Appendix 5] and Walking Impairment Questionnaire [Appendix 6]) at their study intake visit, study exit visit, and at 3, 6, 9, and 12 months following discharge from the rehabilitation program. The 3, 6, 9, and 12-month collection periods will be performed via phone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled in the vascular rehabilitation program at The Heart Hospital Cardiac Rehabilitation Facility.
  • Female or male patients ≥18 years of age.
  • Patient must be accessible for treatment and follow-up.
  • Agrees to wear the activity tracker wrist-worn device
  • Agrees to the follow-up QOL survey schedule
  • Agrees to the follow-up ABI schedule
  • All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.

排除标准

  • Declines participation in the study.
  • Has a life-expectancy less than 18 months.
  • Unable to complete necessary study follow-up procedures.
  • Unwilling to wear the wrist-worn activity tracker device.
  • Women who are pregnant.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
  • severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
  • home oxygen
  • neurologic or orthopedic conditions limiting ability to appropriately comply with rehabilitation program.
  • class III or class IV NY class congestive heart failure
  • Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

结局指标

主要结局

Changes to quality of life surveys at VRP enrollment, VRP discharge, and one year after discharge. Range 7-175

时间窗: Baseline to 1 year after discharge

Quality-of-life survey specific for vasculogenic claudication (VascuQoL) (Range QOL not impacted=175; QOL poorly impacted=7)

Changes to total walking distance at VRP enrollment, VRP discharge, and at one year post discharge

时间窗: 13-15 months

These will be obtained in the VRP at beginning of VRP and termination of VRP. These measurements will also be obtained during the 3-month intervals may be obtained via telephone and remote patient monitoring via the activity tracker if possible. Pain scores related to the claudication will be recorded on a scale of 1-4.

Changes in ankle brachial indices at baseline of VRP and at the termination of VRP (6-12 weeks) (ABI range 0-2)

时间窗: 6-12 weeks (depending on time in the VRP)

ABI will be obtained according to standard practice. Severe disease= \<=0.4; Mild to moderate disease= 0.41-0.9; Normal= \>1.0

Changes to walking distance until symptoms of claudication at VRP enrollment, VRP discharge, and at one year post discharge

时间窗: Baseline to 1 year after discharge

次要结局

  • Rate of lower extremity revascularization intervention that occurs during the study period (1 year following program discharge).(Baseline to 1 year after discharge)
  • Determination of activity level evaluated on daily, weekly, monthly and cumulative levels(Baseline to 1 year after discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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