Boosting Exercise Adherence in Knee Osteoarthritis (BOOST-OA)

VA Office of Research and Development

Status: Begins enrollment in 4 months

Conditions: Osteoarthritis, Knee

Treatments: Behavioral: Usual PT Care (UC); Behavioral: BOOST-OA

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07219732

RRD2-002-24W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of knee OA (verified from the EHR)
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

1. Systemic rheumatic conditions, fibromyalgia, gout (knee)
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Usual PT Care (UC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual PT Care (UC)

BOOST-OA

Experimental group

Description:

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).

Treatment:

Behavioral: BOOST-OA