Osteoarthritis
Conditions
Keywords
Osteoarthritis, Exercise, Diet, Coping Skills, Education, Medical
Brief summary
Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.
Detailed description
Evidence-based guidelines emphasize that adequate management of osteoarthritis (OA) requires a combination of both medical and behavioral modalities. However, many of the recommended guidelines are not regularly incorporated into clinical practice, and the recommended behavioral strategies (e.g. exercise and weight management) are not practiced by most patients. The objective of this study is examine the effectiveness of a combined intervention for patients (involving exercise, weight management, and cognitive behavioral pain management) and providers (involving provision of patient-specific recommendations for care, based on evidence-based guidelines) for improving OA-related outcomes in a real-world VA clinical setting. To our knowledge this is will be the first study to intervene at a both the patient and provider levels for managing OA. This will be a randomized controlled trial of n=300 patients with symptomatic knee or hip OA, with equal assignment to 2 study arms: 1) Patient and Provider Intervention for OA and 2.) Usual Care Control. We will randomize 30 primary care providers at the Durham VAMC and affiliated community based outpatient clinics to either intervention or control groups. We will then enroll 10 patients from each provider (5 White, 5 Non-White). The patient component of the intervention will be a twelve-month program that includes the following elements: written educational materials (focused on exercise, weight management, and cognitive behavioral pain management), an exercise video tailored for patients with lower extremity OA, and telephone calls by a counselor to support behavior change. The provider component of the intervention will involve giving information on patients' OA symptoms and treatment, as well as patient-specific evidence-based recommendations for care. Providers will have access to this information, as well as facilitated referrals for patient-specific treatment recommendations (e.g. physical therapy, orthopedics), at the point of clinical care, via electronic medical records. The primary time point for outcome assessment will be at 12-months. We will also assess a limited set of outcomes via telephone at 6-months. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Secondary outcomes will include objective physical function (Short Physical Performance Test) and depressive symptoms (PHQ-8). The main study analyses will compare outcomes between the intervention and control groups. We will also assess the cost-effectiveness of the intervention.
Interventions
BEHAVIORALOsteoarthritis Intervention
Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* radiographic evidence of hip OA and / or radiographic of or meets clinical criteria for knee OA * current joint symptoms * BMI \>=25 * physically inactive
Exclusion criteria
* Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease * Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months * Active diagnosis of psychosis or serious personality disorder * On waiting list for / planning arthroplasty * Severely impaired hearing or speech (patients must be able to respond to phone calls) * Unable to speak English * No access to a telephone * Participating in another OA intervention or other lifestyle change study * Dementia or other memory loss condition * Current, uncontrolled substance abuse disorder * Motor neuron diseases, Parkinson's Disease, multiple sclerosis * Quadriplegic or paraplegic * Serious / terminal illness as indicated by referral to hospice or palliative care * Other self-reported health problem that would prohibit participation in the study * Nursing home resident * Other health conditions or personal issues judged by a study team member or primary care physician to make the patient inappropriate for the study * Female participants: pregnant or planning to become pregnant * Metastatic Cancer * History of gout in knee or hip * Total joint replacement (knee or hip) surgery, other knee or hip surgery, meniscus tear (verified by MRI), or ACL tear in the past 6 months * Have not seen their VA-assigned primary health care provider for more than a year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | 12-months | Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from none (0) to severe / extreme (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Test Protocol | 12-months | This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance). The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section. |
| PHQ-8 | 12-months | This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section. |
Countries
United States
Participant flow
Recruitment details
Primary care providers in the Durham VA Ambulatory Care Service and their patients were recrutied from this study. Recruitment began on August 4, 2011 and was completed on December 30, 2012.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis. | 149 |
| Osteoarthritis Intervention Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management. | 151 |
| Total | 300 |
Baseline characteristics
| Characteristic | Usual Care | Osteoarthritis Intervention | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 9 | 60.4 years STANDARD_DEVIATION 9.4 | 61.1 years STANDARD_DEVIATION 9.2 |
| Patient Health Questionnaire 8 (PHQ-8) | 6.4 units on a scale STANDARD_DEVIATION 5.13 | 7.2 units on a scale STANDARD_DEVIATION 5.57 | 6.8 units on a scale STANDARD_DEVIATION 5.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 65 Participants | 69 Participants | 134 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 12 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 73 Participants | 67 Participants | 140 Participants |
| Sex: Female, Male Female | 8 Participants | 20 Participants | 28 Participants |
| Sex: Female, Male Male | 141 Participants | 131 Participants | 272 Participants |
| Short Performance Physical Test | 8.1 units on a scale STANDARD_DEVIATION 2.48 | 8.0 units on a scale STANDARD_DEVIATION 2.63 | 8.0 units on a scale STANDARD_DEVIATION 2.6 |
| Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | 47.8 units on a scale STANDARD_DEVIATION 17.4 | 48.9 units on a scale STANDARD_DEVIATION 17.6 | 48.4 units on a scale STANDARD_DEVIATION 17.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 149 | 44 / 151 |
| serious Total, serious adverse events | 18 / 149 | 25 / 151 |
Outcome results
Primary
Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from none (0) to severe / extreme (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.
Time frame: 12-months
Population: All enrolled participants were analyzed, on an intent to treat basis. One enrolled participants in the Usual Care grouped changed clinical care to an enrolled OA Intervention provider after randomization, so that participant was analyzed with the OA intervention group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | Common Baseline | 48.4 units on a scale | Standard Error 1.09 |
| Usual Care | Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | 6-Month | 43.5 units on a scale | Standard Error 1.45 |
| Usual Care | Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | 12-Month | 48.5 units on a scale | Standard Error 1.38 |
| Osteoarthritis Intervention | Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | 6-Month | 41.2 units on a scale | Standard Error 1.47 |
| Osteoarthritis Intervention | Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | Common Baseline | 48.4 units on a scale | Standard Error 1.09 |
| Osteoarthritis Intervention | Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | 12-Month | 44.4 units on a scale | Standard Error 1.39 |
Comparison: This is a comparison of 6-month outcomes between the two study groups. (Primary comparison is for 12 months.)p-value: 0.158Mixed Models Analysis
Comparison: This is the 12-month comparison between the 2 study groups, which is the primary study analysis.p-value: 0.008Mixed Models Analysis
Secondary
PHQ-8
This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.
Time frame: 12-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | PHQ-8 | Common Baseline | 6.83 units on a scale | Standard Error 0.31 |
| Usual Care | PHQ-8 | 12 Months | 6.83 units on a scale | Standard Error 0.39 |
| Osteoarthritis Intervention | PHQ-8 | Common Baseline | 6.83 units on a scale | Standard Error 0.31 |
| Osteoarthritis Intervention | PHQ-8 | 12 Months | 6.21 units on a scale | Standard Error 0.39 |
p-value: 0.177Mixed Models Analysis
Secondary
Short Physical Performance Test Protocol
This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance). The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.
Time frame: 12-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Short Physical Performance Test Protocol | Common Baseline | 8.01 units on a scale | Standard Error 0.149 |
| Usual Care | Short Physical Performance Test Protocol | 12 Months | 7.53 units on a scale | Standard Error 0.233 |
| Osteoarthritis Intervention | Short Physical Performance Test Protocol | Common Baseline | 8.01 units on a scale | Standard Error 0.149 |
| Osteoarthritis Intervention | Short Physical Performance Test Protocol | 12 Months | 7.86 units on a scale | Standard Error 0.237 |
Comparison: This is the between-group 12-month comparison.p-value: 0.274Mixed Models Analysis