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Self-Management of Osteoarthritis (SeMOA)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education
Osteoarthritis Self-Management
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring Self-Care, Telemedicine, Pain, Veterans

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Experimental

Arm Label

Health Education Intervention

Usual Medical Care

Osteoarthritis Self-Management

Arm Description

Health Education Intervention

Usual Medical Care

Osteoarthritis Self-Management

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 6, 2006
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00288912
Brief Title
Self-Management of Osteoarthritis
Acronym
SeMOA
Official Title
Self-Management of Osteoarthritis: A Tailored, Telephone-based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Self-Care, Telemedicine, Pain, Veterans

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
523 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Education Intervention
Arm Type
Active Comparator
Arm Description
Health Education Intervention
Arm Title
Usual Medical Care
Arm Type
No Intervention
Arm Description
Usual Medical Care
Arm Title
Osteoarthritis Self-Management
Arm Type
Experimental
Arm Description
Osteoarthritis Self-Management
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.
Intervention Type
Behavioral
Intervention Name(s)
Osteoarthritis Self-Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
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
Secondary Outcome Measure Information:
Title
AIMS 2 Physical Function
Description
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
Title
AIMS 2 Affect
Description
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
Title
Arthritis Self Efficacy
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli Dominick Allen, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23170757
Citation
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.
Results Reference
result
PubMed Identifier
22440547
Citation
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.
Results Reference
result
PubMed Identifier
23525779
Citation
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.
Results Reference
result
PubMed Identifier
18206425
Citation
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.
Results Reference
result
PubMed Identifier
19825498
Citation
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.
Results Reference
result
PubMed Identifier
21041576
Citation
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.
Results Reference
result
Links:
URL
http://www.durham.hsrd.research.va.gov/
Description
Durham VA HSR&D Center of Excellence (Study Site)

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Self-Management of Osteoarthritis

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