Priming and Patient Reported Outcome Measures
- Conditions
- Patient ParticipationPROM
- Interventions
- Behavioral: Reflection on health-related experiences
- Registration Number
- NCT05229016
- Lead Sponsor
- Columbia University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
18 years of age and older, living in the US, fluent written and spoken English, able to consent
Any criteria that does not meet the inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive health-related experiences and SNOT-22 Reflection on health-related experiences Reflecting on positive health-related experiences SNOT-22 questionnaire Positive health-related experiences and RSDI Reflection on health-related experiences Reflecting on positive health-related experiences RSDI questionnaire Positive health-related experiences and mini-RQLQ Reflection on health-related experiences Reflecting on positive health-related experiences Mini-RQLQ questionnaire Positive health-related experiences and EQ-5D-5L Reflection on health-related experiences Reflecting on positive health-related experiences EQ-5D-5L questionnaire Positive health-related experiences and SF-36 Reflection on health-related experiences Reflecting on positive health-related experiences SF-36 questionnaire Negative health-related experiences and SF-36 Reflection on health-related experiences Reflecting on negative health-related experiences SF-36 questionnaire Negative health-related experiences and mini-RQLQ Reflection on health-related experiences Reflecting on negative health-related experiences Mini-RQLQ questionnaire Negative health-related experiences and PROMIS Reflection on health-related experiences Reflecting on negative health-related experiences PROMIS Global health v1.2 questionnaire Negative health-related experiences and EQ-5D-5L Reflection on health-related experiences Reflecting on negative health-related experiences EQ-5D-5L questionnaire Positive health-related experiences and PROMIS Reflection on health-related experiences Reflecting on positive health-related experiences PROMIS Global health v1.2 questionnaire Negative health-related experiences and SNOT-22 Reflection on health-related experiences Reflecting on negative health-related experiences SNOT-22 questionnaire Negative health-related experiences and RSDI Reflection on health-related experiences Reflecting on negative health-related experiences RSDI questionnaire
- Primary Outcome Measures
Name Time Method 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 worse outcome.
Rhinosinusitis Disability Index (RSDI) score 15 minutes For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the 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.
Sinonasal Outcomes Test (SNOT)-22 score 15 minutes For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse 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 worse 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 worse outcome.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
New York Presbyterian Hospital- Columbia University
🇺🇸New York, New York, United States