Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures

NCT04008680 | Unknown

• 1 other identifier: HiREB 7607
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates how reliability of patient reported outcomes can be affected with questionnaire burden and and the number of questionnaires given to study participants.

Conditions

PROM

Keywords

consistency; reliability; burden; response; methodology

Outcome Measures

Primary Outcomes (1)

• Reliability and validity of the EQ-5D-5L

  The questionnaire selected to analyze reliability in our population is the EQ-5D-5L.This well-known, generic, patient-reported health questionnaire is frequently used in musculoskeletal research and has shown to have a good internal consistency. We will compute the Cronbach's alpha coefficient for the EQ-5D-5L questionnaire. We will contrast these results to analyze if there is any difference in the values obtained from the answers of the EQ-5D-5L questionnaire between the four groups.

  Day 1

Secondary Outcomes (1)

• Time to completion

  Day 1

Study Arms (4)

Low response burden

OTHER

Participants will be assigned to complete only the EQ-5D-5L questionnaire.

Other: EQ-5D-5L survey internal consistency

Low to medium response burden

OTHER

Participants will be assigned to complete the General Anxiety Disorder-7 (GAD-7) questionnaire first, followed by the EQ-5D-5L questionnaire.

Other: EQ-5D-5L survey internal consistency

Medium to high response burden

OTHER

Participants will be assigned to complete the Pain Catastrophizing Scale (PCS) questionnaire first, followed by the GAD-7, and lastly the EQ-5D-5L questionnaire.

Other: EQ-5D-5L survey internal consistency

High response burden

OTHER

Participants will be assigned to complete the Brief Pain Inventory (BPI) questionnaire first, followed by the PCS secondly, the GAD-7 third, and lastly the EQ-5D-5L questionnaire.

Other: EQ-5D-5L survey internal consistency

Interventions

EQ-5D-5L survey internal consistency OTHER

To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.

High response burden; Low response burden; Low to medium response burden; Medium to high response burden

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient presents to the in-person or virtual fracture clinic for his/her own appointment.
• The patient has a fracture that is being managed either operatively or non-operatively.
• Fracture occurred in the past 6 months.
• The patient is 18 years of age or older.
• The patient is able to read, understand, and write in English.
• Patient provides informed, verbal or written consent.

You may not qualify if:

• The patient is considered too ill or injured to participate in the study.
• The patient is cognitively impaired, intoxicated or otherwise unable to provide consent or participate in the study.
• The patient is co-enrolled in another study requiring completion of multiple additional PROMs.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences - General Site

Hamilton, Ontario, Canada

RECRUITING

Study Officials

• Francesc Antoni Marcano-Fernandez, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Herman Johal, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gina Del Fabbro, BPH

CONTACT

2898080709; delfabbg@mcmaster.ca

Carlos Prada

CONTACT

6477818694; pradac@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 group randomized clinical trial

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start: May 17, 2021
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)