Priming and Patient Reported Outcome Measures

NCT ID: NCT05229016

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient Participation PROM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be assigned randomly to complete one of six patient reported outcome measures.

Prior to completion of the patient reported outcome measures, patients will be randomly assigned to one of three groups: Group A where patients will be asked to reflect on positive health-related experiences, Group B where patients will be asked to reflect on negative health-related experiences, Group C where patients will not be asked to reflect on health-related experiences (Control).
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants are masked from knowing the purpose of the study's hypothesis, which is that patient-related factors may influence scores of patient related outcome measures.

Study Groups

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Positive health-related experiences and EQ-5D-5L

Reflecting on positive health-related experiences EQ-5D-5L questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Negative health-related experiences and EQ-5D-5L

Reflecting on negative health-related experiences EQ-5D-5L questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Control and EQ-5D-5L

No intervention/ control group EQ-5D-5L questionnaire

Group Type NO_INTERVENTION

No interventions assigned to this group

Positive health-related experiences and PROMIS

Reflecting on positive health-related experiences PROMIS Global health v1.2 questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Negative health-related experiences and PROMIS

Reflecting on negative health-related experiences PROMIS Global health v1.2 questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Control and PROMIS

No intervention/ control group PROMIS Global health v1.2 questionnaire

Group Type NO_INTERVENTION

No interventions assigned to this group

Positive health-related experiences and SF-36

Reflecting on positive health-related experiences SF-36 questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Negative health-related experiences and SF-36

Reflecting on negative health-related experiences SF-36 questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Control and SF-36

No intervention/ control group SF-36 questionnaire

Group Type NO_INTERVENTION

No interventions assigned to this group

Positive health-related experiences and SNOT-22

Reflecting on positive health-related experiences SNOT-22 questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Negative health-related experiences and SNOT-22

Reflecting on negative health-related experiences SNOT-22 questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Control and SNOT-22

No intervention/ control group SNOT-22 questionnaire

Group Type NO_INTERVENTION

No interventions assigned to this group

Positive health-related experiences and RSDI

Reflecting on positive health-related experiences RSDI questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Negative health-related experiences and RSDI

Reflecting on negative health-related experiences RSDI questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Control and RSDI

No intervention/ control group RSDI questionnaire

Group Type NO_INTERVENTION

No interventions assigned to this group

Positive health-related experiences and mini-RQLQ

Reflecting on positive health-related experiences Mini-RQLQ questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Negative health-related experiences and mini-RQLQ

Reflecting on negative health-related experiences Mini-RQLQ questionnaire

Group Type EXPERIMENTAL

Reflection on health-related experiences

Intervention Type BEHAVIORAL

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Control and mini-RQLQ

No intervention/ control group Mini-RQLQ questionnaire

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reflection on health-related experiences

This is a questionnaire that was designed to make the patient reflect on positive or negative health-related experiences.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Gudis, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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New York Presbyterian Hospital- Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAT8186

Identifier Type: -

Identifier Source: org_study_id

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