OsteoarthritisNCT01003925
Conjoint Analysis of Treatment Preferences for Osteoarthritis
An observational study of Osteoarthritis, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Conjoint Analysis for Osteoarthritis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: People aged 65-95 with knee pain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine Family Medicine
Houston, Texas, 77098
About this study
Official title: Conjoint Analysis of Patient Preferences in Medical Management of Osteoarthritis of the Knee
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Standard of care for osteoarthritis treatment, Conjoint Analysis for Osteoarthritis
- Keywords
- Knee pain, osteoarthritis, non-surgical treatment, age 65+
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care for osteoarthritis treatmentBehavioural
Also called Osteoarthritis usual care
Standard of care educational materials to inform patients about choices for knee pain.
Conjoint Analysis for OsteoarthritisBehavioural
Also called Computer-assisted decision aid
Conjoint Analysis computer software to inform patients about choices for knee pain.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Conjoint Analysis for Osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in osteoarthritis treatment (for instance, change from an NSAID to capsaicin cream) as measured by follow-up telephone interview
Measured: 4 weeks
Secondary outcomes (1)
Ease of use, understandability, and suggestions for improvement of the computer decision aid
Measured: same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startAug 2007
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Simon Whitney, MD, Baylor College of Medicine
- Investigators
- Simon Whitney, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003925
- Sponsor's protocol ID
- 7 U18 HS016093 Leveraged
- Other IDs
- RFA HS 05-014, 7U18HS016093
- Status last verified
- Aug 2015
- First submitted
- 28 Oct 2009
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conjoint Analysis of Patient Preferences in Medical Management of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01003925
- Acronym / sponsor ID
- 7 U18 HS016093 Leveraged
- Conditions
- Osteoarthritis
- Keywords
- Knee pain, osteoarthritis, non-surgical treatment, age 65+
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), M.D. Anderson Cancer Center
- Study start
- Aug 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | Behavioral: Standard of care for osteoarthritis treatmentPatients 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). |
| Conjoint Analysis Group | – | Behavioral: Conjoint Analysis for OsteoarthritisPatients 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). |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- People aged 65-95 with knee pain
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care for osteoarthritis treatmentAlso: Osteoarthritis usual careStandard of care educational materials to inform patients about choices for knee pain. | Behavioural | Usual Care |
| Conjoint Analysis for OsteoarthritisAlso: Computer-assisted decision aidConjoint Analysis computer software to inform patients about choices for knee pain. | Behavioural | Conjoint Analysis Group |
Primary outcome
Change in osteoarthritis treatment (for instance, change from an NSAID to capsaicin cream) as measured by follow-up telephone interview
Time frame: 4 weeks
1 secondary outcome
Ease of use, understandability, and suggestions for improvement of the computer decision aid
Time frame: same day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Whitney, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in osteoarthritis treatment (for instance, change from an NSAID to capsaicin cream) as measured by follow-up telephone interview (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.