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Clinical Trials/NCT04775589
NCT04775589
Active, not recruiting
Not Applicable

Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

Durham VA Medical Center1 site in 1 country19 target enrollmentJune 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Durham VA Medical Center
Enrollment
19
Locations
1
Primary Endpoint
Western Ontario and McMaster Universities Osteoarthritis Index
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this study is to evaluate a telehealth Stepped Exercise Program for Knee OsteoArthritis (STEP-KOA) among rural veterans. Methods: This is a single arm, pre-post pilot trial of the 6-month STEP-KOA program among rural Veterans with a physician diagnosis of knee OA who self-report knee pain ≥3 on a 0-10 scale and self-reported difficulty with either walking or stair climbing. We aim to enroll 20 Veterans in this project but may enroll up to 30 in order to obtain sufficient information to evaluate the program, particularly among Veterans who live in very rural areas. Assessments will be conducted via a combination of telephone and video at baseline and 2-, 4-, and 6-month follow-up. Assessments will include questionnaires related to pain, function and physical activity, as well as several physical performance tests. STEP-KOA begins with a low cost, primarily self-directed exercise program (supported by an internet-based tool; Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps. For this project, patients will be assessed approximately every 2 months to determine step progression. Participants will advance to the next step if they do not meet response criteria for pain and function established by the Outcome Measures in Rheumatology group and the Osteoarthritis Research Society International (OMERACT-OARSI). The Step 2 intervention involves bi-weekly telephone or video calls. Step 3 involves 3 telehealth PT visits, based on standard care for knee OA.

Registry
clinicaltrials.gov
Start Date
June 3, 2021
End Date
March 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Rural dwelling Veterans (VA healthcare users)
  • Clinician diagnosis of knee osteoarthritis
  • Self-reported knee pain =\>3 on a scale of 0-10 and self-reported difficulty either walking or stair climbing.

Exclusion Criteria

  • Advanced Dementia
  • Psychosis
  • Active substance abuse disorder
  • Meniscus or ACL tear in the past 6 months
  • Total joint replacement or other major lower extremity surgery in the past 6 months
  • Severe hearing or visual impairment (e.g. unable to participate in STEP-KOA intervention components)
  • Serious / terminal illness
  • Unstable angina
  • History of ventricular tachycardia
  • Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index

Time Frame: Baseline to 6 months

24-item measure assessing lower extremity pain, stiffness and function. All items are measured on a 5-point Likert scale (0-4; total score 0-96), with higher scores indicating worse symptoms.

Secondary Outcomes

  • 2 minute march test(Baseline to 6 months)
  • 30-second chair stand test(Baseline to 6 months)

Study Sites (1)

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