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

Not Applicable

Terminated

• Conditions: Vascular Diseases; Peripheral Artery Disease; Peripheral Vascular Diseases
• Interventions: Behavioral: Vascular Rehabilitation

• Registration Number: NCT04335695
• Lead Sponsor: Baylor Research Institute

Brief Summary

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.

Detailed Description

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.

Ankle brachial indices will be obtained at the time of study enrollment and again at the completion of the rehabilitation program according to standard practice.

A full medical history and relevant demographic and clinical information will be recorded in a de-identified database. This will include but not be limited to age, gender, BMI, tobacco use and medications. Appendix 1.

Walking distance until symptoms occur and total walking distance will be assessed at the study intake and study exit visits and at 3-month intervals for an additional 12 months. Assessments 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. Appendix 2. Appendix 3.

Every patient will be given a wrist-worn activity tracker to track their daily walking habits during the time period that they are enrolled in the study. This data will be downloaded and stored in the de-identified database.

Following discharge from the vascular rehabilitation program, patients will be contacted every three-months for a year for a follow up quality-of-life survey and walking distance and claudication assessment.

Study Timeline

• Study Start: 2019-12-13
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Primary Completion: 2022-01-24
• Study Completion: 2022-01-24
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

1. Declines participation in the study.

2. Has a life-expectancy less than 18 months.

3. Unable to complete necessary study follow-up procedures.

4. Unwilling to wear the wrist-worn activity tracker device.

5. Women who are pregnant.

6. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:

   1. 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
   2. home oxygen
   3. neurologic or orthopedic conditions limiting ability to appropriately comply with rehabilitation program.
   4. class III or class IV NY class congestive heart failure

7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vascular Rehabilitation and Follow Up	Vascular Rehabilitation	All subjects will be enrolled in a 6-12 Vascular Rehab Program (VRP) and then be followed for one year following discharge from the VRP.

Primary Outcome Measures

Name	Time	Method
Changes to quality of life surveys at VRP enrollment, VRP discharge, and one year after discharge. Range 7-175	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	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)	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	Baseline to 1 year after discharge

Secondary Outcome Measures

Name	Time	Method
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	Measurement of activity (walking distance from pedometer)

Trial Locations

Locations (1)

Baylor Scott & White Heart Hospital- Plano; 🇺🇸 Plano, Texas, United States