Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
360 participants
INTERVENTIONAL
2026-07-01
2030-12-31
Brief Summary
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Detailed Description
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* Aim 1. Examine the effectiveness of BOOST-OA for improving physical function and other key outcomes among Veterans receiving outpatient PT for knee OA using a pragmatic cluster-randomized trial, with 8 VA PT clinics randomized to BOOST-OA vs. usual PT care (UC). Participants will be Veterans with symptomatic knee OA (n=360, 45 per site/180 per study arm). At BOOST-OA sites, behavior initiation components will be provided in conjunction with standard PT visits, and a health coach will deliver maintenance components via telehealth.
* Aim 2. Explore patient characteristics associated with differential improvement following BOOST-OA via a machine learning approach using model-based recursive partitioning. All participant characteristics, social determinants of health (SDOH), and baseline levels of study outcomes will be included in these analyses.
* Aim 3: Conduct qualitative analyses of Veteran and PT clinician experiences with BOOST-OA to inform future implementation. The investigators will conduct semi-structured interviews with Veterans (n=36 across BOOST-OA sites and a subset of UC sites) and PT clinicians delivering care to BOOST-OA participants (n=8-12) to understand acceptability, feasibility, and perceived efficacy of the program, as well as barriers and facilitators to program participation and implementation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Usual PT Care (UC)
UC will be delivered by trained clinicians at participating sites. The study team will provide clinicians with guidance and training to standardize core aspects of PT, aligned with best practice recommendations. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly so that Veterans can practice home exercise and receive guidance in exercise progression. All PT visits must be completed within 3 months.
Usual PT Care (UC)
UC will be delivered by trained clinicians at participating sites. The study team will provide clinicians with guidance and training to standardize core aspects of PT, aligned with best practice recommendations. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly so that Veterans can practice home exercise and receive guidance in exercise progression. All PT visits must be completed within 3 months.
BOOST-OA
BOOST-OA includes components that are integrated into PT visits (concurrent), focused on behavior initiation, as well as components that occur after PT visits have ended (sequential), focused on behavior maintenance. Concurrent components will be delivered in conjunction with usual care PT visits. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly. PT visits must be also completed within 3 months. Sequential components will be delivered by a health coach via phone or video. Health coach sessions will be conducted every other week for the first 2 months (months 4-5), monthly for an additional 3 months (months 6- 8), and every other month for the last 4 months (months 9-12; 9 total contacts). Calls will address strengthening and stretching exercises (≥3 times per week), as well as overall physical activity (e.g., minutes / steps).
BOOST-OA
BOOST-OA includes components that are integrated into PT visits (concurrent), focused on behavior initiation, as well as components that occur after PT visits have ended (sequential), focused on behavior maintenance. Concurrent components will be delivered in conjunction with usual care PT visits. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly. PT visits must be also completed within 3 months. Sequential components will be delivered by a health coach via phone or video. Health coach sessions will be conducted every other week for the first 2 months (months 4-5), monthly for an additional 3 months (months 6- 8), and every other month for the last 4 months (months 9-12; 9 total contacts). Calls will address strengthening and stretching exercises (≥3 times per week), as well as overall physical activity (e.g., minutes / steps).
Interventions
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Usual PT Care (UC)
UC will be delivered by trained clinicians at participating sites. The study team will provide clinicians with guidance and training to standardize core aspects of PT, aligned with best practice recommendations. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly so that Veterans can practice home exercise and receive guidance in exercise progression. All PT visits must be completed within 3 months.
BOOST-OA
BOOST-OA includes components that are integrated into PT visits (concurrent), focused on behavior initiation, as well as components that occur after PT visits have ended (sequential), focused on behavior maintenance. Concurrent components will be delivered in conjunction with usual care PT visits. Clinicians must provide enrolled Veterans with at least 4 PT visits, spaced at least weekly. PT visits must be also completed within 3 months. Sequential components will be delivered by a health coach via phone or video. Health coach sessions will be conducted every other week for the first 2 months (months 4-5), monthly for an additional 3 months (months 6- 8), and every other month for the last 4 months (months 9-12; 9 total contacts). Calls will address strengthening and stretching exercises (≥3 times per week), as well as overall physical activity (e.g., minutes / steps).
Eligibility Criteria
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Inclusion Criteria
2. Knee pain for 3 months
3. Knee pain on most days of the previous month,
4. Average knee pain 3 (on a scale of 0-10),
5. Self-report of some difficulty with walking or stair climbing.
Exclusion Criteria
2. Dementia, psychosis or active substance abuse disorder
3. Meniscus or knee ligament tear in the past 6 months
4. Lower extremity surgery in past 6 months or planned in next 9 months
5. Severe hearing or visual impairment
6. Serious / terminal illness
7. Hospitalization for a cardiovascular event, past 3 months
8. Unstable angina
9. History of ventricular tachycardia
10. Unstable chronic obstructive pulmonary disease
11. Uncontrolled hypertension (diastolic \>110 mm/Hg or systolic \> 200mm/Hg)
12. Stroke with moderate to severe aphasia
13. History of three or more falls in past 6 months
14. Resident of a long-term care facility
15. Other health problem that would prohibit safe participation in the study or home exercise
16. Current participation in another OA intervention study
17. Currently meeting Department of Health and Human Services physical activity recommendations
18. Completed PT for knee OA in the past year
19. Unable to speak sufficient English to participate in study activities
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Kelli Dominick Allen, PhD
Role: PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC
Locations
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Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RRD2-002-24W
Identifier Type: -
Identifier Source: org_study_id
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