search
Back to results

Conjoint Analysis of Treatment Preferences for Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Standard of care for osteoarthritis treatment
Conjoint Analysis for Osteoarthritis
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Osteoarthritis focused on measuring Knee pain, osteoarthritis, non-surgical treatment, age 65+

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Baylor College of Medicine Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Usual Care

Conjoint Analysis Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2009
Last Updated
August 20, 2015
Sponsor
Baylor College of Medicine
Collaborators
Agency for Healthcare Research and Quality (AHRQ), M.D. Anderson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01003925
Brief Title
Conjoint Analysis of Treatment Preferences for Osteoarthritis
Official Title
Conjoint Analysis of Patient Preferences in Medical Management of Osteoarthritis of the Knee
Study Type
Observational

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Agency for Healthcare Research and Quality (AHRQ), M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Osteoarthritis (OA) is a major cause of disability in the elderly, second only to cardiovascular disease. The medical treatment of OA alleviates symptoms, but does not halt disease progression. Exercise is an effective intervention but for patients who do not get adequate relief from exercise and whose disease is not so severe as to warrant joint replacement, there are a variety of intermediate steps including medication and joint injection. There are nontrivial tradeoffs between these choices. This project explores the choices made by patients who have significant osteoarthritis of the knee using specialized computer software as a decision aid. Traditional decision aids present information in ways that help patients make decisions that are consistent with their values. However, this sort of decision aid usually provides no feedback for the clinician or researcher about the patient's thoughts, preferences, or reasoning. We propose to use conjoint analysis, an analytic tool for assessing preferences that has been used extensively in marketing but has only recently been introduced into medical decision making. In conjoint analysis, the consumer (in the marketing context) or subject (in the medical research context) is presented with pairs of choices. The marketing researcher might ask, for instance, if the consumer would rather have a $1000 laptop with 250 MB of RAM, or a $1200 laptop with 500 MB of RAM. The answer allows the accurate calculation of the subject's utilities for both money and RAM. Extending the questions to other elements allows utilities for the laptop's speed, weight, battery life, and screen size to be calculated and allows the computer maker to optimize its product lines. Instead of one sweet spot where price and features are at a happy medium, every laptop offered can be perceived by potential consumers as offering reasonable value for the money. Fraenkel and others have used conjoint analysis in the study of osteoarthritis and rheumatoid arthritis. Conjoint analysis presents choice pairs to subjects; for instance, how would you feel about a cream that offered an extremely low risk of complications with only moderate relief in symptoms, versus a medication that offered a moderate risk of major complications and better symptom relief? As a result of this process, utilities are generated mathematically for each of the preferences. Because we know relatively little about how patients feel about using conjoint analysis, and about making tradeoffs among the factors that conjoint analysis permits us to assess, this project will also utilize patient focus groups to explore these issues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee pain, osteoarthritis, non-surgical treatment, age 65+

7. Study Design

Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Description
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).
Arm Title
Conjoint Analysis Group
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard of care for osteoarthritis treatment
Other Intervention Name(s)
Osteoarthritis usual care
Intervention Description
Standard of care educational materials to inform patients about choices for knee pain.
Intervention Type
Behavioral
Intervention Name(s)
Conjoint Analysis for Osteoarthritis
Other Intervention Name(s)
Computer-assisted decision aid
Intervention Description
Conjoint Analysis computer software to inform patients about choices for knee pain.
Primary Outcome Measure Information:
Title
Change in osteoarthritis treatment (for instance, change from an NSAID to capsaicin cream) as measured by follow-up telephone interview
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Ease of use, understandability, and suggestions for improvement of the computer decision aid
Time Frame
same day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Study Population Description
People aged 65-95 with knee pain
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Whitney, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine Family Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Conjoint Analysis of Treatment Preferences for Osteoarthritis

We'll reach out to this number within 24 hrs