Knee OsteoarthritisGroupPTNCT07215572
Implementing a Group Physical Therapy Program for Veterans (GroupPT): Function QUERI 3.0
A study testing Implementation Strategy: Foundational Arm and Implementation Strategy: REACH Arm in people with Knee Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Implementation Strategy: Foundational Arm and Implementation Strategy: REACH Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sites are eligible to participate if they have:
- 2 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Heidi D Bassani, (919) 286-0411, Heidi.Bassani@va.gov
Kelli Dominick Allen, PhD
About this study
Official title: Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 3.0 (QUE 25-008)
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.
Read the detailed description
Background/Purpose. Exercise-based PT is a key component of guideline concordant knee OA management. However, PT is underutilized for knee OA, resulting in missed opportunities to improve outcomes for the many Veterans with this health condition. A key challenge is the high demand for PT services for knee OA, paired with limited availability of PT services, which can lead to long wait times for Veterans or high community care costs for the VA. Group-based delivery of PT for knee OA can enhance access and efficiency. Following an RCT that supported the effectiveness of Group PT relative to individual PT, the Durham Veterans Affairs Healthcare System (DVAHCS) offered Group PT as a clinical service, and found that patients achieved clinically relevant improvements in pain and functional outcomes that were comparable to those observed in the RCT. Most recently, the investigators conducted a 19-site trial comparing implementation strategies to support delivery of Group PT in the VA. Overall, 16 sites successfully delivered a Group PT program, enrolling a total of 366 Veterans. There were clinically relevant improvements in pain interference and functional outcomes among participating Veterans.
The overall goal of this trial is to evaluate implementation of Group PT with a foundational arm versus the Reach Equity and Collective Health (REACH) arm.
Methodology. To evaluate implementation of Group PT, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or the REACH arm. Implementation activities will occur over a 12-month period. The Group PT program includes 6 sessions that include exercise and educational content. Patients will be eligible for Group PT if they have a clinician diagnosis of symptomatic knee OA and ineligible if they have a substantial fall risk or co-occurring health conditions that would make participation in a group exercise class unsafe. The primary follow-up outcome time-point will be 18 months; metrics will also be evaluated at 12 months (reach, patient engagement). Implementation outcomes include 1) Reach (primary), defined as the number of patients initiating Group PT, 2) Patient Engagement, defined as the average number of sessions attended by patients who initiate the EBP, and 3) Time to Adoption, defined as the time from baseline to launching a Group PT program and enrolling 5 Veterans. Generalized linear models will be used to examine the effect of Foundational vs. REACH arms on reach and patient engagement.
- Conditions
- Knee Osteoarthritis
- Being tested
- Implementation Strategy: Foundational Arm, Implementation Strategy: REACH Arm
- Keywords
- Veterans, Implementation Science, Functional Status, Physical Therapy, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Strategy: Foundational ArmOther
The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports.
Implementation Strategy: REACH ArmOther
The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Implementation Strategy: REACH Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.
Measured: 18 months
Secondary outcomes (4)
Reach
Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.
Measured: 12 months
Time to Adoption
Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (Adoption will be defined as launching a Group PT program and having ≥5 Veterans initiate Group PT). This will be computed for each site meeting the adoption criteria.
Measured: 18 months
Patient Engagement
Patient engagement will be defined as the average number of sessions attended by patients who initiate Group PT at a site.
Measured: 12 months
Patient Engagement
Patient engagement will be defined as the average number of sessions attended by patients who initiate Group PT at a site.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start30 Apr 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kelli Dominick Allen, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215572
- Sponsor's protocol ID
- QUX 25-002
- Acronym
- GroupPT
- Status last verified
- May 2026
- First submitted
- 6 Oct 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Group Physical Therapy Program for Veterans With Knee Osteoarthritis: Function QUERI 3.0 (QUE 25-008)
- ClinicalTrials.gov ID
- NCT07215572
- Acronym / sponsor ID
- GroupPT / QUX 25-002
- Conditions
- Knee Osteoarthritis
- Keywords
- Veterans, Implementation Science, Functional Status, Physical Therapy, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/Purpose. Exercise-based PT is a key component of guideline concordant knee OA management. However, PT is underutilized for knee OA, resulting in missed opportunities to improve outcomes for the many Veterans with this health condition. A key challenge is the high demand for PT services for knee OA, paired with limited availability of PT services, which can lead to long wait times for Veterans or high community care costs for the VA. Group-based delivery of PT for knee OA can enhance access and efficiency. Following an RCT that supported the effectiveness of Group PT relative to individual PT, the Durham Veterans Affairs Healthcare System (DVAHCS) offered Group PT as a clinical service, and found that patients achieved clinically relevant improvements in pain and functional outcomes that were comparable to those observed in the RCT. Most recently, the investigators conducted a 19-site trial comparing implementation strategies to support delivery of Group PT in the VA. Overall, 16 sites successfully delivered a Group PT program, enrolling a total of 366 Veterans. There were clinically relevant improvements in pain interference and functional outcomes among participating Veterans.
The overall goal of this trial is to evaluate implementation of Group PT with a foundational arm versus the Reach Equity and Collective Health (REACH) arm.
Methodology. To evaluate implementation of Group PT, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or the REACH arm. Implementation activities will occur over a 12-month period. The Group PT program includes 6 sessions that include exercise and educational content. Patients will be eligible for Group PT if they have a clinician diagnosis of symptomatic knee OA and ineligible if they have a substantial fall risk or co-occurring health conditions that would make participation in a group exercise class unsafe. The primary follow-up outcome time-point will be 18 months; metrics will also be evaluated at 12 months (reach, patient engagement). Implementation outcomes include 1) Reach (primary), defined as the number of patients initiating Group PT, 2) Patient Engagement, defined as the average number of sessions attended by patients who initiate the EBP, and 3) Time to Adoption, defined as the time from baseline to launching a Group PT program and enrolling 5 Veterans. Generalized linear models will be used to examine the effect of Foundational vs. REACH arms on reach and patient engagement.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Foundational Arm | Active comparator | Other: Implementation Strategy: Foundational ArmFoundational 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. |
| REACH (Reach Equity And Collective Health) Arm | Experimental | Other: Implementation Strategy: REACH ArmThe REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 2 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation Strategy: Foundational ArmThe Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports. | Other | Foundational Arm |
| Implementation Strategy: REACH ArmThe REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation. | Other | REACH (Reach Equity And Collective Health) Arm |
Primary outcome
Reach
Time frame: 18 months
Reach will be defined as the number of patients initiating (completing the first session of) Group PT at a site.
4 secondary outcomes
Reach
Time frame: 12 months
Time to Adoption
Time frame: 18 months
Patient Engagement
Time frame: 12 months
Patient Engagement
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelli Dominick Allen, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Strategy: Foundational Arm and Implementation Strategy: REACH Arm in people with Knee Osteoarthritis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin B Kappler, MSW ((919) 286-6936, Caitlin.Kappler@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.