Priming and Patient Reported Outcome Measures

NCT05229016 | Completed

• 1 other identifier: AAAT8186
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Participation; PROM

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Present Mood Visual Analogue Scale

  15 minutes

Study Arms (18)

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

EXPERIMENTAL

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

Behavioral: Reflection on health-related experiences

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

EXPERIMENTAL

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

Behavioral: Reflection on health-related experiences

Control and EQ-5D-5L

NO INTERVENTION

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

Positive health-related experiences and PROMIS

EXPERIMENTAL

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

Behavioral: Reflection on health-related experiences

Negative health-related experiences and PROMIS

EXPERIMENTAL

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

Behavioral: Reflection on health-related experiences

Control and PROMIS

NO INTERVENTION

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

Positive health-related experiences and SF-36

EXPERIMENTAL

Reflecting on positive health-related experiences SF-36 questionnaire

Behavioral: Reflection on health-related experiences

Negative health-related experiences and SF-36

EXPERIMENTAL

Reflecting on negative health-related experiences SF-36 questionnaire

Behavioral: Reflection on health-related experiences

Control and SF-36

NO INTERVENTION

No intervention/ control group SF-36 questionnaire

Positive health-related experiences and SNOT-22

EXPERIMENTAL

Reflecting on positive health-related experiences SNOT-22 questionnaire

Behavioral: Reflection on health-related experiences

Negative health-related experiences and SNOT-22

EXPERIMENTAL

Reflecting on negative health-related experiences SNOT-22 questionnaire

Behavioral: Reflection on health-related experiences

Control and SNOT-22

NO INTERVENTION

No intervention/ control group SNOT-22 questionnaire

Positive health-related experiences and RSDI

EXPERIMENTAL

Reflecting on positive health-related experiences RSDI questionnaire

Behavioral: Reflection on health-related experiences

Negative health-related experiences and RSDI

EXPERIMENTAL

Reflecting on negative health-related experiences RSDI questionnaire

Behavioral: Reflection on health-related experiences

Control and RSDI

NO INTERVENTION

No intervention/ control group RSDI questionnaire

Positive health-related experiences and mini-RQLQ

EXPERIMENTAL

Reflecting on positive health-related experiences Mini-RQLQ questionnaire

Behavioral: Reflection on health-related experiences

Negative health-related experiences and mini-RQLQ

EXPERIMENTAL

Reflecting on negative health-related experiences Mini-RQLQ questionnaire

Behavioral: Reflection on health-related experiences

Control and mini-RQLQ

NO INTERVENTION

No intervention/ control group Mini-RQLQ questionnaire

Interventions

Reflection on health-related experiences 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; Negative health-related experiences and PROMIS; Negative health-related experiences and RSDI; Negative health-related experiences and SF-36; Negative health-related experiences and SNOT-22; Negative health-related experiences and mini-RQLQ; Positive health-related experiences and EQ-5D-5L; Positive health-related experiences and PROMIS; Positive health-related experiences and RSDI; Positive health-related experiences and SF-36; Positive health-related experiences and SNOT-22; Positive health-related experiences and mini-RQLQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• Northwestern University: collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

New York Presbyterian Hospital- Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• David Gudis, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 8, 2022
• Study Start: November 9, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)