Priming and Patient Reported Outcome Measures

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05229016

Collaborator

Northwestern University (Other), Medical University of South Carolina (Other)

1,800

Enrollment

Location

Arms

7.7

Anticipated Duration (Months)

235.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Condition or Disease	Intervention/Treatment	Phase
Patient Participation PROM	Behavioral: Reflection on health-related experiences	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Other

Official Title:

Priming Subjects to Influence Responses to Patient Reported Outcome Measures

Actual Study Start Date :

Nov 9, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

EQ-5D-5L score [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 worst outcome.
PROMIS Global health v1.2 score [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 worst outcome.
SF-36 score [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.
SNOT-22 score [15 minutes]
For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worst the outcome.
RSDI score [15 minutes]
For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worst the outcome.
mini-RQLQ score [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 worst score

Secondary Outcome Measures

Present Mood Visual Analogue Scale [15 minutes]
10 cm visual analogue scale to rate mood. The scale is between 0 and 10. A higher score represents a better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital- Columbia University	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University
Northwestern University
Medical University of South Carolina

Investigators

Study Chair: David Gudis, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nathan Yang, Principal investigator, Columbia University

ClinicalTrials.gov Identifier:

NCT05229016

Other Study ID Numbers:

AAAT8186

First Posted:

Feb 8, 2022

Last Update Posted:

Feb 8, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 8, 2022