Type II DiabetesNCT02637622
Measuring the Preferences of Patients With Type II Diabetes Using Best-worst Scaling and Discrete Choice Experiment
An observational study of Type II Diabetes, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Best-Worst Scaling (Case 2) and Discrete Choice Experiment
- How many people
- 1,103 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with type II diabetes.
Who may be able to join
- Participate in the GfK's KnowledgePanel
- Self-reported Type II diabetes diagnosis
Who cannot join
- Does not have Type II diabetes diagnosis
- Unable to communicate in English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes
In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a factor that CDRH may consider in regulatory reviews. It underlined the need for developing methods to measure patient preference and incorporate it into regulatory decision-making. The purpose of this study is to advance methods for patient and community engagement in patient-centered outcome research (PCOR) and has three objectives.
First, demonstrate good practices for patient and community involvement in PCOR projects by applying principles of community-based participatory research (CBPR).
Read more
Second, address methodological gaps pertaining to the use of stated-preference methods in studying preferences in PCOR. These include identifying the best methods for designing a preference study and strategies for analyzing variation in preferences. The investigators also seek to assess the relevance of stated-preference methods to patients and stakeholders using both qualitative and quantitative methods.
Third, demonstrate good practices for applying stated-preference methods by studying the preferences of patients with type II diabetes. While type II diabetes provides an important case study, this research will advance approaches and methods that will be broadly generalizable to other diseases, and to diverse patient and stakeholder groups.
Clinical Significance:
This project will illustrate and advance methods for assessing the values of patients and stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of stated-preference methods in measuring the preferences of patients and stakeholders and directing health care.
Read the detailed description
This study will apply the principles of CBPR to involve patients and stakeholders associated with a local community board and a national diabetes advisory board in key decisions in the project. During year 1, the investigators will utilize mixed methods to develop, pretest, and pilot the survey instruments to assess the preferences of patients with type II diabetes. In year 2, the investigators plan further engagement to finalize the survey instruments, and will implement a nationally representative, racially/ethnically diverse sample of patients with type II diabetes. Based on further consultation, the investigators will conduct statistical analysis, including stratified analyses and segmentation of patients with similar preferences. In year 3, mixed methods will be applied to assess beliefs of patients and other consumers about the relevance of this work and its generalizability to other PCOR topics. Finally, lay language reports will be developed to highlight patient and stakeholder engagement and the application of stated-preference methods to the study of the preferences of patients with type II diabetes.
- Conditions
- Type II Diabetes
- Being tested
- Best-Worst Scaling (Case 2), Discrete Choice Experiment
- Keywords
- conjoint analysis, stated-preference methods, patient centered outcome research (PCOR), community-based participatory research (CBPR), patient preference, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Preference, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best-Worst Scaling (Case 2)Other
Respondents receive questions asking them to choose the best and worst features of a hypothetical medication.
Discrete Choice ExperimentOther
Respondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications.
| Study group | Role | What they receive |
|---|---|---|
| Best-Worst Scaling (Case 2) | Preference measured by best-worst scaling (case 2) Receives: Other: Best-Worst Scaling (Case 2) | |
| Discrete Choice Experiment | Preference measured by discrete choice experiment Receives: Other: Discrete Choice Experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Medication Preference as Estimated by a Choice Model
Preference estimate for each medicine attribute level from a conditional logit regression analysis. For each arm, there were six attributes of the medication, with 3 levels each. Within each attribute the parameter estimates for each of the levels sum to 0. If a parameter estimate for a level is above (below) 0 then the parameter is higher (lower) than average for that medication attribute.
Measured: One-time survey
Weight Respondents Assign to Medication Attribute (Relative Attribute Importance) Assessed by a Choice Model
Relative attribute importance (RAI) for each attribute in each arm measures the overall importance of that attribute. It is estimated by subtracting the lowest parameter estimate from the highest parameter estimate within each attribute. The RAI was then re-scaled on a 0 to 10 scale with 0 demonstrating no importance and 10 reflecting the most important attribute in each arm.
Measured: One-time survey
Secondary outcomes (1)
Self-reported Difficulty in Understanding and Answering the Survey Questions
Questions that asked the respondents to evaluate if the Best-Worst Scaling (BWS) or Discrete Choice Experiment (DCE tasks were easy to understand and answer.
Measured: One-time survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJul 2013
- Primary completionOct 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- John Bridges, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637622
- Sponsor's protocol ID
- PCORI 90056532 PF
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2015
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT02637622
- Acronym / sponsor ID
- PCORI 90056532 PF
- Conditions
- Type II Diabetes
- Keywords
- conjoint analysis, stated-preference methods, patient centered outcome research (PCOR), community-based participatory research (CBPR), patient preference, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,103 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jul 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a factor that CDRH may consider in regulatory reviews. It underlined the need for developing methods to measure patient preference and incorporate it into regulatory decision-making. The purpose of this study is to advance methods for patient and community engagement in patient-centered outcome research (PCOR) and has three objectives.
First, demonstrate good practices for patient and community involvement in PCOR projects by applying principles of community-based participatory research (CBPR).
Second, address methodological gaps pertaining to the use of stated-preference methods in studying preferences in PCOR. These include identifying the best methods for designing a preference study and strategies for analyzing variation in preferences. The investigators also seek to assess the relevance of stated-preference methods to patients and stakeholders using both qualitative and quantitative methods.
Third, demonstrate good practices for applying stated-preference methods by studying the preferences of patients with type II diabetes. While type II diabetes provides an important case study, this research will advance approaches and methods that will be broadly generalizable to other diseases, and to diverse patient and stakeholder groups.
Clinical Significance:
This project will illustrate and advance methods for assessing the values of patients and stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of stated-preference methods in measuring the preferences of patients and stakeholders and directing health care.
Detailed description
This study will apply the principles of CBPR to involve patients and stakeholders associated with a local community board and a national diabetes advisory board in key decisions in the project. During year 1, the investigators will utilize mixed methods to develop, pretest, and pilot the survey instruments to assess the preferences of patients with type II diabetes. In year 2, the investigators plan further engagement to finalize the survey instruments, and will implement a nationally representative, racially/ethnically diverse sample of patients with type II diabetes. Based on further consultation, the investigators will conduct statistical analysis, including stratified analyses and segmentation of patients with similar preferences. In year 3, mixed methods will be applied to assess beliefs of patients and other consumers about the relevance of this work and its generalizability to other PCOR topics. Finally, lay language reports will be developed to highlight patient and stakeholder engagement and the application of stated-preference methods to the study of the preferences of patients with type II diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best-Worst Scaling (Case 2) | – | Other: Best-Worst Scaling (Case 2)Preference measured by best-worst scaling (case 2) |
| Discrete Choice Experiment | – | Other: Discrete Choice ExperimentPreference measured by discrete choice experiment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with type II diabetes.
Key inclusion criteria (2 listed)
- Participate in the GfK's KnowledgePanel
- Self-reported Type II diabetes diagnosis
Key exclusion criteria (2 listed)
- Does not have Type II diabetes diagnosis
- Unable to communicate in English or Spanish
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 |
|---|---|---|
| Best-Worst Scaling (Case 2)Respondents receive questions asking them to choose the best and worst features of a hypothetical medication. | Other | Best-Worst Scaling (Case 2) |
| Discrete Choice ExperimentRespondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications. | Other | Discrete Choice Experiment |
Primary outcome
Patient Medication Preference as Estimated by a Choice Model
Time frame: One-time survey
Preference estimate for each medicine attribute level from a conditional logit regression analysis. For each arm, there were six attributes of the medication, with 3 levels each. Within each attribute the parameter estimates for each of the levels sum to 0. If a parameter estimate for a level is above (below) 0 then the parameter is higher (lower) than average for that medication attribute.
Weight Respondents Assign to Medication Attribute (Relative Attribute Importance) Assessed by a Choice Model
Time frame: One-time survey
Relative attribute importance (RAI) for each attribute in each arm measures the overall importance of that attribute. It is estimated by subtracting the lowest parameter estimate from the highest parameter estimate within each attribute. The RAI was then re-scaled on a 0 to 10 scale with 0 demonstrating no importance and 10 reflecting the most important attribute in each arm.
1 secondary outcome
Self-reported Difficulty in Understanding and Answering the Survey Questions
Time frame: One-time survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Bridges, PhD principal investigator
Johns Hopkins University
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 Type II Diabetes, run by Johns Hopkins Bloomberg School of Public Health 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 2 inclusion and 2 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 29 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Medication Preference as Estimated by a Choice Model (time frame: One-time survey). The study lists 2 primary outcomes in all. 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 29 Nov 2024.