Priming and Patient Reported Outcome Measures

April 21, 2023 updated by: Columbia University

Priming Subjects to Influence Responses to Patient Reported Outcome Measures

The objective of the study is to assess which health-related questionnaire is the most accurate and reliable.

The hypothesis is that some health-related questionnaires are more reliable than others.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of the study is to test the reliability of patient reported outcome measures, and their robustness to patient-related factors.

Patients will be randomly assigned to complete 1 of 6 patient reported outcome measures. Patients will either be asked to reflect on health-related experiences or not prior to completion of the questionnaire. Basic non-identifiable demographic information, and a brief medical questionnaire will follow completion of the patient reported outcome measure.

Results from each individual patient reported outcome measure will be compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital- Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

18 years of age and older, living in the US, fluent written and spoken English, able to consent

Exclusion Criteria:

Any criteria that does not meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Positive health-related experiences and EQ-5D-5L
Reflecting on positive health-related experiences EQ-5D-5L questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and EQ-5D-5L
Reflecting on negative health-related experiences EQ-5D-5L questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and EQ-5D-5L
No intervention/ control group EQ-5D-5L questionnaire
Experimental: Positive health-related experiences and PROMIS
Reflecting on positive health-related experiences PROMIS Global health v1.2 questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and PROMIS
Reflecting on negative health-related experiences PROMIS Global health v1.2 questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and PROMIS
No intervention/ control group PROMIS Global health v1.2 questionnaire
Experimental: Positive health-related experiences and SF-36
Reflecting on positive health-related experiences SF-36 questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and SF-36
Reflecting on negative health-related experiences SF-36 questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and SF-36
No intervention/ control group SF-36 questionnaire
Experimental: Positive health-related experiences and SNOT-22
Reflecting on positive health-related experiences SNOT-22 questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and SNOT-22
Reflecting on negative health-related experiences SNOT-22 questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and SNOT-22
No intervention/ control group SNOT-22 questionnaire
Experimental: Positive health-related experiences and RSDI
Reflecting on positive health-related experiences RSDI questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and RSDI
Reflecting on negative health-related experiences RSDI questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and RSDI
No intervention/ control group RSDI questionnaire
Experimental: Positive health-related experiences and mini-RQLQ
Reflecting on positive health-related experiences Mini-RQLQ questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
Experimental: Negative health-related experiences and mini-RQLQ
Reflecting on negative health-related experiences Mini-RQLQ questionnaire
Behavioral: Reflection on health-related experiences
This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.
No Intervention: Control and mini-RQLQ
No intervention/ control group Mini-RQLQ questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SF-36 score
Time Frame: 15 minutes
For the SF-36, a score of 0 to 100 is calculated for the domains of physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well-being, social functioning, pain, and general health. A higher score represents a more favorable outcome.
15 minutes
EQ-5D-5L score
Time Frame: 15 minutes
For the EQ-5D-5L, a scale of 1 to 5 with descriptors is used to score the domains of mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. A higher score represents a worse outcome.
15 minutes
PROMIS Global health v1.2 score
Time Frame: 15 minutes
For the PROMIS Global Health v1.2, a score of 4 to 20 is calculated for the global physical health domain, and a score of 4 to 20 is calculated for the global mental health domain. A higher score represents a worse outcome.
15 minutes
Sinonasal Outcomes Test (SNOT)-22 score
Time Frame: 15 minutes
For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse the outcome.
15 minutes
Rhinosinusitis Disability Index (RSDI) score
Time Frame: 15 minutes
For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the outcome.
15 minutes
mini-RQLQ score
Time Frame: 15 minutes
For the mini-RQLQ, a score 0 to 18 is calculated for the activities domain, 0 to 12 for the practical problems domain, 0 to 18 for the nose symptoms domain, 0 to 18 for the eye symptoms domain, and 0 to 18 for the other symptoms domain. A higher score represents a worse outcome.
15 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Present Mood Visual Analogue Scale
Time Frame: 15 minutes
10 cm visual analogue scale to rate mood. The scale is between 0 and 10. A higher score represents a better outcome
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Gudis, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAT8186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will potentially be shared upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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