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Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling

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ClinicalTrials.gov Identifier: NCT02637609
Recruitment Status : Unknown
Verified October 2015 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief 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 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.


Condition or disease Intervention/treatment
Type II Diabetes Other: Likert Scale Other: Best-Worst Scaling (Case 1)

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes
Study Start Date : July 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Likert Scale
Priority elicitation survey using a Likert scale method.
Other: Likert Scale
Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management.

Best-Worst Scaling (Case 1)
Priority elicitation survey using a best-worst scaling method.
Other: 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.




Primary Outcome Measures :
  1. Measuring patients' priorities for barriers and facilitators for diabetes self-management using Likert scale [ Time Frame: The outcome will be evaluated during a one-time survey conducted one year after the start of the study. ]
    The investigators will measure patients' view on the barriers and facilitators for diabetes self-management using a survey with the traditional Likert scale method.

  2. Measuring patients' priorities for barriers and facilitators for diabetes self-management using Best-Worst Scaling [ Time Frame: The outcome will be evaluated during a one-time survey conducted one year after the start of the study. ]
    The investigators will measure patients' view on the barriers and facilitators for diabetes self-management using a survey with the best-worst scaling (case 1) method.


Other Outcome Measures:
  1. Self-reported difficulty in understanding and answering the survey questions [ Time Frame: The outcome will be evaluated during the surveys conducted one year after the start of the study. ]
    The survey will ask the respondents to evaluate whether it is easy to understand and answer the questions using Likert scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with type II diabetes.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637609


Locations
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United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: John Bridges, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02637609    
Other Study ID Numbers: PCORI 90056532
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: October 2015
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
conjoint analysis
stated-preference methods
patient centered outcome research (PCOR)
community-based participatory research (CBPR)
patient priority
diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases