Boosting Exercise Adherence in Knee Osteoarthritis

Official title

Boosting Exercise Adherence in Knee Osteoarthritis (BOOST-OA)

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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.
• Behavioral 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

Primary outcome measures

• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale [Time frame: Baseline]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale [Time frame: Change from baseline to 3-months]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale [Time frame: Change from baseline to 12-months (primary outcome time point)]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale [Time frame: Change from baseline to 18-months]
• Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale [Time frame: Change from baseline to 24-months]

Secondary outcome measures (12)

• Patient Specific Functional Scale [Time frame: Baseline]
• 30-second Chair Stand [Time frame: Baseline]
• 2-minute Step Test [Time frame: Baseline]
• WOMAC pain subscale [Time frame: Baseline]
• WOMAC Total Score [Time frame: Baseline]
• Patient Specific Functional Scale [Time frame: Change from baseline to 3-months]
• Minutes of physical activity [Time frame: Baseline]
• Patient Specific Functional Scale [Time frame: Change from baseline to 12-months (primary outcome time point)]
• Patient Specific Functional Scale [Time frame: Change from baseline to 18-months]
• Patient Specific Functional Scale [Time frame: Change from baseline to 24-months]
• Minutes of physical activity [Time frame: Change from baseline to 12-months (primary outcome time point)]
• Minutes of physical activity [Time frame: Change from baseline to 24-months]

Eligibility criteria

Inclusion criteria

• Diagnosis of knee OA (verified from the EHR)
• Knee pain for 3 months
• Knee pain on most days of the previous month,
• Average knee pain 3 (on a scale of 0-10),
• Self-report of some difficulty with walking or stair climbing.

Exclusion criteria

• Systemic rheumatic conditions, fibromyalgia, gout (knee)
• Dementia, psychosis or active substance abuse disorder
• Meniscus or knee ligament tear in the past 6 months
• Lower extremity surgery in past 6 months or planned in next 9 months
• Severe hearing or visual impairment
• Serious / terminal illness
• Hospitalization for a cardiovascular event, past 3 months
• Unstable angina
• History of ventricular tachycardia
• Unstable chronic obstructive pulmonary disease
• Uncontrolled hypertension (diastolic >110 mm/Hg or systolic > 200mm/Hg)
• Stroke with moderate to severe aphasia
• History of three or more falls in past 6 months
• Resident of a long-term care facility
• Other health problem that would prohibit safe participation in the study or home exercise
• Current participation in another OA intervention study
• Currently meeting Department of Health and Human Services physical activity recommendations
• Completed PT for knee OA in the past year
• Unable to speak sufficient English to participate in study activities

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Durham VA Medical Center, Durham, NC — Durham

Identifiers

NCT: NCT07219732 · RRD2-002-24W

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗