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OpenTrials
Completed

NCT Number: NCT05229016

Priming and Patient Reported Outcome Measures

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.

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Key information

Conditions

Patient Participation Behavior Health Behavior PROM Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital- Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. EQ-5D-5L score

    Time frame: 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.

  2. PROMIS Global health v1.2 score

    Time frame: 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.

  3. SF-36 score

    Time frame: 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.

  4. Sinonasal Outcomes Test (SNOT)-22 score

    Time frame: 15 minutes

    For the SNOT-22, a total score of 0 to 110 is calculated. The higher the score, the worse the outcome.

  5. Rhinosinusitis Disability Index (RSDI) score

    Time frame: 15 minutes

    For the RSDI, a total score of 0 to 120 is calculated. The higher the score, the worse the outcome.

  6. mini-RQLQ score

    Time frame: 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.

Secondary outcomes

  1. Present Mood Visual Analogue Scale

    Time frame: 15 minutes

    10 cm visual analogue scale to rate mood. The scale is between 0 and 10. A higher score represents a better outcome

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Medical University of South Carolina
  • Northwestern University

Registry information

Official study title

Priming Subjects to Influence Responses to Patient Reported Outcome Measures

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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