Priming and Patient Reported Outcome Measures

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Priming Subjects to Influence Responses to Patient Reported Outcome Measures

ClinicalTrials.gov ID

NCT05229016

Acronym / sponsor ID

AAAT8186

Conditions

Patient Participation, PROM

Study type

Interventional

Recruitment status

Completed

Enrolment

900 participants (actual)

Lead sponsor

Columbia UniversityUniversity, hospital or other

Collaborators

Northwestern University, Medical University of South Carolina

Study start

9 Nov 2021 (actual)

Primary completion

28 Feb 2022 (actual)

Study completion

28 Feb 2022 (actual)

First posted

8 Feb 2022 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Other

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (participant)

Number of arms

18

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).

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
• Individual participant dataSharing planned: Undecided. IPD will potentially be shared upon reasonable request

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.