NCT07215572

Brief Summary

Implementing Group Physical Therapy for Veterans with Knee Osteoarthritis (Group PT): Function QUERI 3.0 aims to compare two implementation approaches for implementing Group PT in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
51mo left

Started Apr 2026

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Sep 2030

First Submitted

Initial submission to the registry

October 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

4.4 years

First QC Date

October 6, 2025

Last Update Submit

May 1, 2026

Conditions

Keywords

VeteransImplementation ScienceFunctional StatusPhysical TherapyOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Reach

    Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.

    18 months

Secondary Outcomes (4)

  • Reach

    12 months

  • Time to Adoption

    18 months

  • Patient Engagement

    12 months

  • Patient Engagement

    18 months

Study Arms (2)

Foundational Arm

ACTIVE COMPARATOR

Foundational Arm uses the Replicating Effective Program (REP) implementation strategy and includes 3 elements that were developed and tested in our prior Function QUERI work: program initiation, self-guided resources, and technical assistance.

Other: Implementation Strategy: Foundational Arm

REACH (Reach Equity And Collective Health) Arm

EXPERIMENTAL

The REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring.

Other: Implementation Strategy: REACH Arm

Interventions

The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports.

Foundational Arm

The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.

REACH (Reach Equity And Collective Health) Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sites are eligible to participate if they have:
  • outpatient PT clinicians (one primary and one back-up) for delivering Group PT
  • space to conduct group sessions (if delivering Group PT in person) or ability to conduct visits via telehealth (video)
  • Patients will be eligible for Group PT if they have a clinician diagnosis of symptomatic knee OA.

You may not qualify if:

  • Site will be ineligible to participate if they are already conducting a group physical therapy class for patients with knee OA.
  • Patients will be ineligible for Group PT if they have a substantial fall risk or co-occurring health conditions that would make participation in a group exercise class unsafe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kelli Dominick Allen, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin B Kappler, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to two interventions: Foundational Arm (active comparator) vs. Reach Equity And Collective Health (REACH) arm (experimental).
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2025

First Posted

October 10, 2025

Study Start

April 30, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that include variables from statistical models presented in publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data is included in the dataset.

Shared Documents
STUDY PROTOCOL
Time Frame
Available upon request.
Access Criteria
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.
More information

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