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Group Physical Therapy for Knee Osteoarthritis (Group PT Trial)
N/A
Waitlist Available
Led By Kelli Dominick Allen, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (cumulative)
Awards & highlights
Group PT Trial Summary
This trial will compare implementation strategies for Group PT in 16 VA sites, and also gather information about the clinical intervention and related outcomes.
Who is the study for?
This trial is for VA sites with staff to evaluate and lead group physical therapy, outpatient PT service, space for group sessions, and a signed agreement. Sites already offering knee OA classes or previously in Function QUERI are excluded.Check my eligibility
What is being tested?
The study tests two strategies (Foundational REP and Enhanced REP) to implement Group Physical Therapy at 16 VA sites for veterans with knee osteoarthritis using an effectiveness-implementation hybrid design framework.See study design
What are the potential side effects?
Since this trial focuses on the implementation of physical therapy rather than a drug intervention, it does not directly involve medication side effects. However, participants may experience typical physical therapy-related discomforts.
Group PT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months (cumulative)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (cumulative)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Penetration
Secondary outcome measures
Adoption
Fidelity
Group PT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced REPExperimental Treatment1 Intervention
EnREP begins with the same activities as foundational REP. Sites that do not meet EBP-specific a priori benchmarks reflecting adoption within 6 months will continue with foundational REP and will receive higher intensity support for a period of 6 months (enREP). Additionally, sites randomized to enREP that met adoption benchmarks but did do not meet the sustainment benchmark, will also receive intensified implementation support for the remainder of the study period (3 months). The higher intensity support will include one-on-one calls approximately every 3 to 4 weeks between site implementation teams and a trained practice facilitator (from Function QUERI team). The facilitator will coach individual sites using techniques, processes, and activities to help teams make decisions and identify and solve problems. Facilitators? actions will depend on each site?s needs and clinical context.
Group II: Foundational REPActive Control1 Intervention
Foundational REP uses the Replicating Effective Program implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: Stakeholder engagement; Toolkit; SharePoint access for clinical program training materials; Data dashboard to assist sites with tracking their own data; and Diffusion Networks to promote peer-to-peer sharing and implementation support.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,585 Total Patients Enrolled
21 Trials studying Osteoarthritis
3,523 Patients Enrolled for Osteoarthritis
Kelli Dominick Allen, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
9 Previous Clinical Trials
1,647 Total Patients Enrolled
5 Trials studying Osteoarthritis
1,512 Patients Enrolled for Osteoarthritis
Susan N. Hastings, MD MHScPrincipal InvestigatorDurham VA Medical Center, Durham, NC
5 Previous Clinical Trials
14,603 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My healthcare facility has staff for evaluations and group classes.My treatment center has space for group sessions.My treatment center does not offer group classes for knee osteoarthritis.My treatment center offers outpatient physical therapy services.I have been diagnosed with knee osteoarthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Foundational REP
- Group 2: Enhanced REP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators looking for more participants at this time?
"This particular trial is not currently looking for new enrolments, as shown on clinicaltrials.gov. The study was created on 6/21/2022 and last updated on 10/14/2022; however, there are 728 other active trials that patients can participate in."
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