NCT00288912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
523

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5 years until next milestone

Results Posted

Study results publicly available

September 12, 2014

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

February 6, 2006

Results QC Date

August 1, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

Self-CareTelemedicinePainVeterans

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • AIMS 2 Physical Function

    Baseline and 12-month follow-up

  • AIMS 2 Affect

    Baseline and 12 months

  • Arthritis Self Efficacy

    Baseline and 12 months

Study Arms (3)

Health Education Intervention

ACTIVE COMPARATOR

Health Education Intervention

Behavioral: Health Education

Usual Medical Care

NO INTERVENTION

Usual Medical Care

Osteoarthritis Self-Management

EXPERIMENTAL

Osteoarthritis Self-Management

Behavioral: Osteoarthritis Self-Management

Interventions

12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.

Health Education Intervention

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.

Osteoarthritis Self-Management

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographic evidence of hip or knee osteoarthritis
  • Current / persistent joint symptoms (pain, aching, stiffness)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

OsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Kelli Allen
Organization
Durham VA HSR&D

Study Officials

  • Kelli Dominick Allen, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

October 1, 2006

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

April 24, 2015

Results First Posted

September 12, 2014

Record last verified: 2015-04

Locations