NCT01003925

Brief Summary

The purpose of this study is to develop a conjoint analysis-based questionnaire and decision aid for patients with osteoarthritis of the knee and to compare the responses of two groups of subjects, one receiving only printed information about knee osteoarthritis, the other participating in a computer-based adaptive conjoint analysis program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

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

Study Start

First participant enrolled

August 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

3 years

First QC Date

October 28, 2009

Last Update Submit

August 20, 2015

Conditions

Keywords

Knee pain, osteoarthritis, non-surgical treatment, age 65+

Outcome Measures

Primary Outcomes (1)

  • Change in osteoarthritis treatment (for instance, change from an NSAID to capsaicin cream) as measured by follow-up telephone interview

    4 weeks

Secondary Outcomes (1)

  • Ease of use, understandability, and suggestions for improvement of the computer decision aid

    same day

Study Arms (2)

Usual Care

Patients randomized to the control group will be sent the post-test measures suitably modified to reflect the fact that they did not participate in the conjoint analysis program. Four weeks after the post-test measures are completed, a staff member will call the subject to complete a 10 minute follow-up questionnaire to assess if any changes in treatment have occurred and to take further measurements (same measurements given to treatment group).

Behavioral: Standard of care for osteoarthritis treatment

Conjoint Analysis Group

Patients randomized to the experimental group will meet the research staff to complete the conjoint analysis software and post-test measures. The post-test measures include preparedness for decision-making, personal uncertainty, osteoarthritis knowledge, arthritis self-efficacy, and satisfaction with the results of the conjoint analysis program. The in-person visit takes approximately 60 minutes to complete. Four weeks after the in-person visit, a staff member will call the subject to complete a 10 minute follow-up questionnaire to assess if any changes in treatment have occurred and to take further measurements (i.e. global pain assessment, arthritis self-efficacy, personal uncertainty, and osteoarthritis knowledge).

Behavioral: Conjoint Analysis for Osteoarthritis

Interventions

Standard of care educational materials to inform patients about choices for knee pain.

Also known as: Osteoarthritis usual care
Usual Care

Conjoint Analysis computer software to inform patients about choices for knee pain.

Also known as: Computer-assisted decision aid
Conjoint Analysis Group

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People aged 65-95 with knee pain

You may qualify if:

  • Age 65 or older
  • Knee pain over the past month on most days
  • Able to travel to Family Medicine offices, if in the treatment group
  • Able to read and understand English
  • Able to answer questions on a computer screen

You may not qualify if:

  • Bleeding or non-bleeding ulcer within the last year
  • History of ruptured ulcer (ever)
  • History of GI bleeding (ever)
  • Currently taking Coumadin or blood-thinning medication
  • Diagnosis of lupus (ever), psoriatic arthritis (ever), gout (current or within past year), rheumatoid arthritis (ever), or coronary artery disease (ever)
  • Prior total knee replacement or scheduled to get knee replacement in painful knee(s)
  • Satisfied with current knee pain treatment
  • Unable to get to a doctor for knee pain if needed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine Family Medicine

Houston, Texas, 77098, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Simon Whitney, M.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

August 1, 2007

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations