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NCT04775589 · ClinicalTrials.gov registry record · NA
Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis
A NA study of Knee Osteoarthritis, sponsored by Durham VA Medical Center.
- Active
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04775589 is a NA study of Knee Osteoarthritis that is active but no longer recruiting, run by Durham VA Medical Center. The registered enrollment target is 19 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04775589, a NA study of Knee Osteoarthritis, is active but no longer recruiting, sponsored by Durham VA Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Stepped Exercise for Knee Osteoarthritis
Study Locations (1)
North Carolina
- Durham VA Healthcare System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-06-03 |
| Est. Completion | 2025-03-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04775589
The ClinicalTrials.gov registry entry for NCT04775589 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (94% lower). The listed sponsor is Durham VA Medical Center, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Stepped Exercise for Knee Osteoarthritis is the first listed.
NCT04775589 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04775589 about?
NCT04775589 is a clinical study titled "Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis". 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 pai...
What is the current status of trial NCT04775589?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 19 participants. The study started on 2021-06-03. Estimated completion is 2025-03-15.
What conditions does trial NCT04775589 study?
This clinical trial studies the following conditions: Knee Osteoarthritis.
What interventions are being tested in trial NCT04775589?
The interventions under investigation include: Stepped Exercise for Knee Osteoarthritis (BEHAVIORAL).
Who is sponsoring clinical trial NCT04775589?
This trial is sponsored by Durham VA Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04775589 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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