Osteoarthritis
Conditions
Keywords
Self-Care, Telemedicine, Pain, Veterans
Brief summary
The purpose of this study is to examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee.
Detailed description
Background / Rationale: Osteoarthritis (OA) is the one of the most common chronic conditions among veterans, and over half of VA health care users with OA report being limited in their daily activities because of joint symptoms. However, studies have not examined interventions to improve outcomes or quality of care among the large and growing number of veterans with OA. Telephone-based self-management interventions may be a cost-effective way to improve pain, physical function, and other outcomes in this patient population. Objective: The purpose of this study is to examine the effectiveness of a one-year telephone-based self-management intervention for veterans with hip or knee OA. The primary hypothesis is that the self-management intervention will result in a greater reduction in pain as compared to both usual care and attention control conditions. Methods: This will be a randomized control trial of 519 veterans at the Durham VAMC who have radiographic evidence and a physician diagnosis of OA of the hip or knee. Participants will be equally allocated to self-management, attention control, and usual care groups. The self-management intervention is designed to provide participants with key information about OA and its treatment and to enhance participants' self-efficacy for managing OA-related symptoms. This intervention will involve provision of written, audio, and video educational materials, as well as monthly telephone calls by a nurse. The nurse will guide participants in developing personal OA-related goals, as well as specific plans for meeting these goals. Other strategies for enhancing self-efficacy will include modeling and mastery of self-management behaviors, persuasion to adopt these behaviors, and reinterpretation of OA symptoms. The attention control group will receive written materials on health screening related topics (not OA-related), and the nurse will call participants on a monthly basis to discuss these materials. The primary outcome measure for this study will be self-reported pain (Arthritis Impact Measurement-2 (AIMS2) subscale), and secondary outcomes will be self-reported function (AIMS2 subscale), affect (AIMS2 subscale), and arthritis specific self-efficacy. Outcomes will be measured at baseline and following the one-year study period. Analysis of covariance will be used to compare primary and secondary outcomes between the intervention group and each of the control groups, adjusting for baseline measures, participant demographic and clinical characteristics. We will also examine the cost-effectiveness of the intervention. Impact: This study is significant because it examines a highly prevalent but understudied chronic illness among veterans. In addition, this OA self-management program will contribute to the VA health care system's specific mission to improve pain management through patient education and participation. The proposed self-management intervention will be low-cost and easy to disseminate within the VA health care system. Therefore it may be an important tool for improving outcomes, especially pain, among many veterans with OA.
Interventions
BEHAVIORALHealth Education
12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.
BEHAVIORALOsteoarthritis Self-Management
12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Radiographic evidence of hip or knee osteoarthritis * Current / persistent joint symptoms (pain, aching, stiffness)
Exclusion criteria
* Other rheumatic disease (i.e., rheumatoid arthritis, fibromyalgia) * Hospitalization for stroke or cardiovascular event within past 3 months * Metastatic cancer * Active diagnosis of psychosis * Terminal illness * On waiting list for arthroplasty * Resident of nursing home * Severely impaired in hearing or speech (participants must be able to respond to phone calls) * Significant cognitive dysfunction * No access to a telephone * Current participation in another interventional study for osteoarthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Baseline and 12-month follow-up | Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale (all days to no days). The possible range of scores is 0-10, with higher scores indicating more severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AIMS 2 Physical Function | Baseline and 12-month follow-up | The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale (all days to no days). Scores can range from 0-10, with higher scores indicating worse function. |
| AIMS 2 Affect | Baseline and 12 months | The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale (all days to no days). Scores can range from 0-10, with higher scores indicating worse affect. |
| Arthritis Self Efficacy | Baseline and 12 months | The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy. |
Countries
United States
Participant flow
Recruitment details
Recruitment began on Oct 3, 2006 and ended on June 30, 2008. We used VA medical records to identify patients with hip and knee OA and no exclusionary diagnoses. We mailed introductory letters to these individuals and followed up with a screening phone call. Eligible patients were asked to come to the Durham VA for a baseline visit.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Health Education Intervention
Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics. | 172 |
| Arm 2 Usual Medical Care | 171 |
| Arm 3 Osteoarthritis Self-Management
Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis. | 172 |
| Total | 515 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Developed exclusion criterion | 4 | 6 | 7 |
| Overall Study | Lost to Follow-up | 9 | 6 | 9 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 12 |
Baseline characteristics
| Characteristic | Total | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 10.4 | 60.3 years STANDARD_DEVIATION 10.8 | 59.7 years STANDARD_DEVIATION 10.1 | 60.3 years STANDARD_DEVIATION 10.3 |
| Race/Ethnicity, Customized Non-White | 237 participants | 81 participants | 79 participants | 77 participants |
| Race/Ethnicity, Customized White | 278 participants | 91 participants | 92 participants | 95 participants |
| Region of Enrollment United States | 515 participants | 172 participants | 171 participants | 172 participants |
| Sex: Female, Male Female | 37 Participants | 12 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 478 Participants | 160 Participants | 161 Participants | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 33 / 175 | 25 / 174 | 36 / 174 |
| serious Total, serious adverse events | 10 / 175 | 7 / 174 | 14 / 174 |
Outcome results
Primary
Pain
Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale (all days to no days). The possible range of scores is 0-10, with higher scores indicating more severe pain.
Time frame: Baseline and 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Pain | Baseline | 6.01 units on a scale | Standard Deviation 2.28 |
| Arm 1 | Pain | 12-Month Follow-Up | 5.84 units on a scale | Standard Deviation 2.32 |
| Arm 2 | Pain | Baseline | 5.77 units on a scale | Standard Deviation 2.14 |
| Arm 2 | Pain | 12-Month Follow-Up | 5.46 units on a scale | Standard Deviation 2.03 |
| Arm 3 | Pain | Baseline | 5.92 units on a scale | Standard Deviation 2.27 |
| Arm 3 | Pain | 12-Month Follow-Up | 5.22 units on a scale | Standard Deviation 2.44 |
Comparison: Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.00795% CI: [-1, 0.2]Mixed Models Analysis
Comparison: Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.10595% CI: [-0.8, 0.1]Mixed Models Analysis
Secondary
AIMS 2 Affect
The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale (all days to no days). Scores can range from 0-10, with higher scores indicating worse affect.
Time frame: Baseline and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | AIMS 2 Affect | Baseline | 3.64 units on a scale | Standard Deviation 2.26 |
| Arm 1 | AIMS 2 Affect | 12-Month Follow-Up | 3.44 units on a scale | Standard Deviation 2.2 |
| Arm 2 | AIMS 2 Affect | Baseline | 3.23 units on a scale | Standard Deviation 2.04 |
| Arm 2 | AIMS 2 Affect | 12-Month Follow-Up | 3.08 units on a scale | Standard Deviation 2.09 |
| Arm 3 | AIMS 2 Affect | Baseline | 3.74 units on a scale | Standard Deviation 2.29 |
| Arm 3 | AIMS 2 Affect | 12-Month Follow-Up | 3.58 units on a scale | Standard Deviation 3.35 |
Comparison: Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.7895% CI: [-0.3, 0.4]Mixed Models Analysis
Comparison: Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.7995% CI: [-0.3, 0.4]Mixed Models Analysis
Secondary
AIMS 2 Physical Function
The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale (all days to no days). Scores can range from 0-10, with higher scores indicating worse function.
Time frame: Baseline and 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | AIMS 2 Physical Function | Baseline | 2.70 units on a scale | Standard Deviation 1.78 |
| Arm 1 | AIMS 2 Physical Function | 12-Month Follow-Up | 2.87 units on a scale | Standard Deviation 1.94 |
| Arm 2 | AIMS 2 Physical Function | Baseline | 2.27 units on a scale | Standard Deviation 1.34 |
| Arm 2 | AIMS 2 Physical Function | 12-Month Follow-Up | 2.34 units on a scale | Standard Deviation 1.55 |
| Arm 3 | AIMS 2 Physical Function | Baseline | 2.60 units on a scale | Standard Deviation 1.68 |
| Arm 3 | AIMS 2 Physical Function | 12-Month Follow-Up | 2.57 units on a scale | Standard Deviation 1.77 |
Comparison: Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.09395% CI: [-0.5, 0]Mixed Models Analysis
Comparison: Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.4395% CI: [-0.2, 0.2]Mixed Models Analysis
Secondary
Arthritis Self Efficacy
The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.
Time frame: Baseline and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Arthritis Self Efficacy | Baseline | 5.78 units on a scale | Standard Deviation 2.01 |
| Arm 1 | Arthritis Self Efficacy | 12-Month Follow-Up | 5.80 units on a scale | Standard Deviation 2.06 |
| Arm 2 | Arthritis Self Efficacy | Baseline | 5.92 units on a scale | Standard Deviation 1.92 |
| Arm 2 | Arthritis Self Efficacy | 12-Month Follow-Up | 5.96 units on a scale | Standard Deviation 1.96 |
| Arm 3 | Arthritis Self Efficacy | Baseline | 5.68 units on a scale | Standard Deviation 2.07 |
| Arm 3 | Arthritis Self Efficacy | 12-Month Follow-Up | 6.09 units on a scale | Standard Deviation 2.13 |
Comparison: Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.04395% CI: [0, 0.8]Mixed Models Analysis
Comparison: Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.p-value: 0.06695% CI: [0, 0.7]Mixed Models Analysis