Priming and Patient Reported Outcome Measures

Patient Participation Clinical Trial

Official title:

Priming Subjects to Influence Responses to Patient Reported Outcome Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229016
• Other study ID #: AAAT8186
• Status: Completed
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Participation
• PROM

Intervention

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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital- Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Medical University of South Carolina, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EQ-5D-5L score	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
Primary	PROMIS Global health v1.2 score	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
Primary	SF-36 score	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
Primary	Sinonasal Outcomes Test (SNOT)-22 score	For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse the outcome.	15 minutes
Primary	Rhinosinusitis Disability Index (RSDI) score	For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the outcome.	15 minutes
Primary	mini-RQLQ score	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	Present Mood Visual Analogue Scale	10 cm visual analogue scale to rate mood. The scale is between 0 and 10. A higher score represents a better outcome	15 minutes