Self-Management of Osteoarthritis (SeMOA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00288912
First received: February 6, 2006
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Behavioral: Health Education
Behavioral: Osteoarthritis Self-Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Self-Management of Osteoarthritis: A Tailored, Telephone-based Intervention

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Pain [ Time Frame: Baseline and 12-month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12-month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 523
Study Start Date: October 2006
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Health Education Intervention
Health Education Intervention
Behavioral: Health Education
12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.
No Intervention: Usual Medical Care
Usual Medical Care
Experimental: Osteoarthritis Self-Management
Osteoarthritis Self-Management
Behavioral: 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288912

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Kelli Dominick Allen, PhD Durham VA Medical Center, Durham, NC
  More Information

Additional Information:
Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00288912     History of Changes
Other Study ID Numbers: IIR 04-016
Study First Received: February 6, 2006
Results First Received: August 1, 2014
Last Updated: September 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Self-Care
Telemedicine
Pain
Veterans

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014