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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Education Intervention | Active Comparator | Health Education Intervention |
|
| Usual Medical Care | No Intervention | Usual Medical Care | |
| Osteoarthritis Self-Management | Experimental | Osteoarthritis Self-Management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Dominick Allen, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23170757 | Result | Sperber NR, Allen KD, Devellis BM, Devellis RF, Lewis MA, Callahan LF. Differences in effectiveness of the active living every day program for older adults with arthritis. J Aging Phys Act. 2013 Oct;21(4):387-401. doi: 10.1123/japa.21.4.387. Epub 2012 Nov 19. | |
| 22440547 | Result | Sperber NR, Bosworth HB, Coffman CJ, Juntilla KA, Lindquist JH, Oddone EZ, Walker TA, Weinberger M, Allen KD. Participant evaluation of a telephone-based osteoarthritis self-management program, 2006-2009. Prev Chronic Dis. 2012;9:E73. Epub 2012 Mar 22. |
| Label | URL |
|---|---|
| Durham VA HSR\&D Center of Excellence (Study Site) | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm 2 | Usual Medical Care |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Among n=523 who consented and were randomized 8 were excluded from analyses because subsequent review of VA medical records revealed there was no documentation of radiographic evidence of knee or hip OA and therefore these participants did not meet initial eligibility requirements.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Arm 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-month follow-up |
|
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We have entered adverse events in relatively broad categories (e.g., Hospital Admission, Emergency Room Visit) because this was what was collected in order to meet reporting requirements of the IRB. More specific adverse event data was not required or collected, and none of the adverse events were study related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Not Study Related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | Gastrointestinal disorders | Not study-related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelli Allen | Durham VA HSR&D | 919-286-0411 | 7090 | kelli.allen@va.gov |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Osteoarthritis Self-Management | Behavioral | 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. |
|
| 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. | Baseline and 12 months |
| 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. | Baseline and 12 months |
| 23525779 | Result | Sperber NR, Bosworth HB, Coffman CJ, Lindquist JH, Oddone EZ, Weinberger M, Allen KD. Differences in osteoarthritis self-management support intervention outcomes according to race and health literacy. Health Educ Res. 2013 Jun;28(3):502-11. doi: 10.1093/her/cyt043. Epub 2013 Mar 22. |
| 18206425 | Result | Allen KD, Oddone EZ, Stock JL, Coffman CJ, Lindquist JH, Juntilla KA, Lemmerman DS, Datta SK, Harrelson ML, Weinberger M, Bosworth HB. The Self-Management of OsteoArthritis in Veterans (SeMOA) Study: design and methodology. Contemp Clin Trials. 2008 Jul;29(4):596-607. doi: 10.1016/j.cct.2007.11.004. Epub 2007 Nov 22. |
| 19825498 | Result | Allen KD, Oddone EZ, Coffman CJ, Keefe FJ, Lindquist JH, Bosworth HB. Racial differences in osteoarthritis pain and function: potential explanatory factors. Osteoarthritis Cartilage. 2010 Feb;18(2):160-7. doi: 10.1016/j.joca.2009.09.010. Epub 2009 Oct 1. |
| 21041576 | Result | Allen KD, Oddone EZ, Coffman CJ, Datta SK, Juntilla KA, Lindquist JH, Walker TA, Weinberger M, Bosworth HB. Telephone-based self-management of osteoarthritis: A randomized trial. Ann Intern Med. 2010 Nov 2;153(9):570-9. doi: 10.7326/0003-4819-153-9-201011020-00006. |
| Withdrawal by Subject |
|
Usual Medical Care
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-month follow-up |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
|
|
| 10 |
| 175 |
| 33 |
| 175 |
| EG001 | Arm 2 | Usual Medical Care | 7 | 174 | 25 | 174 |
| EG002 | 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. | 14 | 174 | 36 | 174 |
| Hospital Admission | Cardiac disorders | Not Study Related |
|
| Hospital Admission | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Not Study Related |
|
| Hospital Admission | Infections and infestations | Not Study Related |
|
| Hospital Admission | General disorders | Not Study Related |
|
| Inpatient Surgery | Surgical and medical procedures | Not Study Related |
|
| Significant Disability | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Not Study Related |
|
| Hospital Admission | Renal and urinary disorders | Not Study Related |
|
| Hospital Admission | Respiratory, thoracic and mediastinal disorders | Not Study Related |
|
| Hospital Admission | Musculoskeletal and connective tissue disorders | Not Study Related |
|
| Hospital Admission | Endocrine disorders | Not Study Related |
|
| Significant Disability | Nervous system disorders | Not Study Related |
|
| Hospital Admission | Hepatobiliary disorders | Not Study Related |
|
| Emergency Room Visit | Musculoskeletal and connective tissue disorders | Not study related |
|
| Emergency Room Visit | Respiratory, thoracic and mediastinal disorders | Not study related |
|
| Emergency Room Visit | General disorders |
|
| Emergency Room Visit | Cardiac disorders | Not Study Related |
|
| Emergency Room Visit | Ear and labyrinth disorders | Not Study Related |
|
| Emergency Room Visit | Renal and urinary disorders | Not Study Related |
|
| Outpatient Surgery | Surgical and medical procedures | Not Study Related |
|
| Emergency Room Visit | Psychiatric disorders | Not Study Related |
|
| Emergency Room Visit | Vascular disorders | Not Study Related |
|
| Emergency Room Visit | Eye disorders | Not Study Related |
|
| Emergency Room Visit | Skin and subcutaneous tissue disorders | Not Study Related |
|
| Emergency Room Visit | Infections and infestations | Not Study Related |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| 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. | Mixed Models Analysis | 0.43 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.2 | 0.2 | The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models. | No | Superiority or Other |
|
| 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. | Mixed Models Analysis | 0.79 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.3 | 0.4 | The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models. | No | Superiority or Other |
|
| 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. | Mixed Models Analysis | 0.066 | Mean Difference (Final Values) | 0.4 | 2-Sided | 95 | 0.0 | 0.7 | The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models. | No | Superiority or Other |