Type II DiabetesNCT02637609
Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling
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?
- Likert Scale and Best-Worst Scaling (Case 1)
- 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 priorities in PCOR. These include identifying the best methods for identifying patient priorities and strategies for analyzing variation in priorities. 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 priorities 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 priorities 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 priorities 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 priorities. 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 priorities of patients with type II diabetes.
- Conditions
- Type II Diabetes
- Being tested
- Likert Scale, Best-Worst Scaling (Case 1)
- Keywords
- conjoint analysis, stated-preference methods, patient centered outcome research (PCOR), community-based participatory research (CBPR), patient priority, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Likert ScaleOther
Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management.
Best-Worst Scaling (Case 1)Other
Respondents receive questions asking them to choose the best and worst factors that affect their diabetes self-management among a list of barriers and facilitators.
| Study group | Role | What they receive |
|---|---|---|
| Likert Scale | Priority elicitation survey using a Likert scale method. Receives: Other: Likert Scale | |
| Best-Worst Scaling (Case 1) | Priority elicitation survey using a best-worst scaling method. Receives: Other: Best-Worst Scaling (Case 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management
Average Likert score or best-worst score that measures the impact of each factor on diabetes self-management. Positive scores indicate facilitators for diabetes self-management while negative scores indicate barriers. The magnitude of the score suggests the degree of the impact. Both scales are on a +1--1 scale. Positive 1 would be the largest possible facilitator and a negative 1 would be the largest possible barrier.
Measured: One-time survey
Secondary outcomes (1)
Self-reported Difficulty in Understanding and Answering the Survey Questions
Questions that asked respondents to evaluate whether it was easy to understand and answer the Likert scale or BWS tasks.
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 completionFeb 2017
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT02637609
- Sponsor's protocol ID
- PCORI 90056532
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2015
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bridges JFP, Janssen EM, Zhou M, Bone L, Segal JB, Purnell T, Longo DR, Wu A. Comparing Different Ways of Asking People with Type 2 Diabetes about Their Care Priorities and Preferences [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2019 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK594947/
PubMed 37733885
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. 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
- NCT02637609
- Acronym / sponsor ID
- PCORI 90056532
- Conditions
- Type II Diabetes
- Keywords
- conjoint analysis, stated-preference methods, patient centered outcome research (PCOR), community-based participatory research (CBPR), patient priority, 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
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 24 Jan 2025
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 priorities in PCOR. These include identifying the best methods for identifying patient priorities and strategies for analyzing variation in priorities. 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 priorities 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 priorities 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 priorities 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 priorities. 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 priorities of patients with type II diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Likert Scale | – | Other: Likert ScalePriority elicitation survey using a Likert scale method. |
| Best-Worst Scaling (Case 1) | – | Other: Best-Worst Scaling (Case 1)Priority elicitation survey using a best-worst scaling method. |
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 |
|---|---|---|
| Likert ScaleRespondents receive questions asking them to rate each barrier or facilitator for diabetes self-management. | Other | Likert Scale |
| Best-Worst Scaling (Case 1)Respondents receive questions asking them to choose the best and worst factors that affect their diabetes self-management among a list of barriers and facilitators. | Other | Best-Worst Scaling (Case 1) |
Primary outcome
Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management
Time frame: One-time survey
Average Likert score or best-worst score that measures the impact of each factor on diabetes self-management. Positive scores indicate facilitators for diabetes self-management while negative scores indicate barriers. The magnitude of the score suggests the degree of the impact. Both scales are on a +1--1 scale. Positive 1 would be the largest possible facilitator and a negative 1 would be the largest possible barrier.
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 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37733885Bridges JFP, Janssen EM, Zhou M, Bone L, Segal JB, Purnell T, Longo DR, Wu A. Comparing Different Ways of Asking People with Type 2 Diabetes about Their Care Priorities and Preferences [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2019 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK594947/
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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 24 Jan 2025. 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 24 Jan 2025). 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?
Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management (time frame: One-time survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637609, which also lists 1 linked publication.
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 Jan 2025.