This project, conducted within the Department of Veterans Affairs Healthcare System (VHA), will test the effectiveness of an intervention to improve adherence to home exercise among Veterans receiving physical therapy (PT) for knee osteoarthritis (OA). The intervention, "Boosting Exercise Adherence in Knee Osteoarthritis" (BOOST-OA), has two phases. During the initiation phase (first 3 months of PT care), patients will receive tools and activities to address outcome expectations, action self-efficacy, goal-setting and monitoring. During the behavior maintenance phase (starting after PT care and continuing for 9 months), patients will receive health coaching calls that address satisfaction with outcomes, relapse prevention planning and independent monitoring. There are three main study aims: (1) examine improvements in patient outcomes, such as physical function, following BOOST-OA; (2) explore patient characteristics that lead to difference in reported improvements; and (3) interview participants and clinicians about their experience with BOOST-OA to inform future implementation.
In this project, the investigators will test the effectiveness of a theoretically-informed, scalable intervention to enhance adherence to home exercise among Veterans receiving PT for knee OA. "Boosting Exercise Adherence in Knee Osteoarthritis" (BOOST-OA) includes components that address both exercise behavior initiation (conducted in conjunction with the PT episode of care) and maintenance (conducted after completion of PT care). Specifically, BOOST-OA includes: 1) Tools and activities woven into PT visits that address outcome expectations, action self-efficacy, goal-setting and monitoring (3-month behavior initiation phase) and 2) Health coaching calls that address satisfaction with outcomes, relapse prevention planning and independent monitoring (9-month behavior maintenance phase). This project is being conducted within the Department of Veterans Affairs Healthcare system (VHA). Specific aims are: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
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 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).
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).
Time frame: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).
Time frame: Change from baseline to 3-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).
Time frame: Change from baseline to 12-months (primary outcome time point)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).
Time frame: Change from baseline to 18-months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale
The investigators selected physical function as the primary outcome because of its high importance to individuals with knee OA and its relevance for PT and exercise-based interventions. The WOMAC has been used widely in the context of clinical trials for knee OA and has well established psychometric properties including reliability, construct validity, internal consistency, and sensitivity to change in the context of behavioral interventions for knee OA. The WOMAC function subscale consists of 17 items rated on a Likert scale of 0 (no difficulty) to 4 (extreme difficulty).
Time frame: Change from baseline to 24-months
Patient Specific Functional Scale
This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.
Time frame: Baseline
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Time frame: Baseline
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Time frame: Baseline
WOMAC pain subscale
In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).
Time frame: Baseline
WOMAC Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Time frame: Baseline
Patient Specific Functional Scale
This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.
Time frame: Change from baseline to 3-months
Minutes of physical activity
The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline
Patient Specific Functional Scale
This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.
Time frame: Change from baseline to 12-months (primary outcome time point)
Patient Specific Functional Scale
This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.
Time frame: Change from baseline to 18-months
Patient Specific Functional Scale
This modified version of the Patient Specific Functional Scale will ask participants to identify one important activity they are unable to do or are having difficulty with as a result of their knee OA. They then rate their ability to perform the identified activity from 0=unable to perform to 10=able to perform at the same level as before having knee OA.
Time frame: Change from baseline to 24-months
Minutes of physical activity
The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.
Time frame: Change from baseline to 12-months (primary outcome time point)
Minutes of physical activity
The investigators will utilize validated algorithms to calculate average minutes of light and moderate-to-vigorous physical activity per day assessed by accelerometer.
Time frame: Change from baseline to 24-months
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Time frame: Change from baseline to 3-months
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Time frame: Change from baseline to 12-months (primary outcome time point)
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Time frame: Change from baseline to 18-months
30-second Chair Stand
The number of times that a participant can stand up from a seated position and sit back down in 30-seconds.
Time frame: Change from baseline to 24-months
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Time frame: Change from baseline to 3-months
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Time frame: Change from baseline to 12-months (primary outcome time point)
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Time frame: Change from baseline to 18-months
2-minute Step Test
The number of times a participant can step in place in a 2-minute period.
Time frame: Change from baseline to 24-months
WOMAC pain subscale
In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).
Time frame: Change from baseline to 3-months
WOMAC pain subscale
In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).
Time frame: Change from baseline to 12-months (primary outcome time point)
WOMAC pain subscale
In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).
Time frame: Change from baseline to 18-months
WOMAC pain subscale
In addition to the WOMAC function subscale, the investigators will assess the WOMAC pain subscale (score range 0-20, higher scores indicate greater pain severity).
Time frame: Change from baseline to 24-months
WOMAC Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Time frame: Change from baseline to 3-months
WOMAC Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Time frame: Change from baseline to 12-months (primary outcome time point)
WOMAC Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Time frame: Change from baseline to 18-months
WOMAC Total Score
The investigators will combine WOMAC subscales to calculate a total score (score range 0-96, higher scores indicate greater pain, stiffness, and functional limitation).
Time frame: Change from baseline to 24-months
Average Step Count
The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.
Time frame: Baseline
Average Step Count
The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.
Time frame: Change from baseline to 12-months (primary outcome time point)
Average Step Count
The investigators will utilize validated algorithms to calculate average steps per day assessed by accelerometer.
Time frame: Change from baseline to 24-months