Overview

This trial is active, not recruiting.

Condition type ii diabetes
Treatments best-worst scaling (case 2), discrete choice experiment
Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborator Patient-Centered Outcomes Research Institute
Start date July 2013
End date June 2016
Trial size 1000 participants
Trial identifier NCT02637622, PCORI 90056532 PF

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
Arm
Preference elicitation survey using a best-worst scaling method.
best-worst scaling (case 2)
Respondents receive questions asking them to choose the best and worst features of a hypothetical medication.
Preference elicitation survey using a discrete choice experiment method.
discrete choice experiment
Respondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications.

Primary Outcomes

Measure
The importance of lowering hemoglobin A1C level from patient perspective
time frame: This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
The importance of having stable blood glucose levels from patient perspective
time frame: This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
The importance of avoiding hypoglycemia from patient perspective
time frame: This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
The importance of avoiding nausea from patient perspective
time frame: This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
The importance of minimizing treatment burden from patient perspective
time frame: This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.
The importance of medication cost from patient perspective
time frame: This outcome will be evaluated during a one-time survey that will be conducted one year after the start of the study.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Participate in the GfK's KnowledgePanel - Self-reported Type II diabetes diagnosis Exclusion Criteria: - Does not have Type II diabetes diagnosis - Unable to communicate in English or Spanish

Additional Information

Official title Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes
Principal investigator John Bridges, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health.