Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT04008680

Conditions

PROM

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EQ-5D-5L survey internal consistency

Study Details

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

Study ID

NCT04008680

Start date

May 17, 2021

Status verified date

Jul, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Jul 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Low response burden

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

other: Low to medium response burden

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

other: Medium to high response burden

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: High response burden

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.

Interventions

EQ-5D-5L survey internal consistency

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

Primary outcome measure

  • Reliability and validity of the EQ-5D-5L [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

Hamilton Health Sciences - General Site

Recruiting

Hamilton, Ontario, Canada

Contacts

Principal Investigator:

Herman Johal, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Jul 28, 2021

Last verified

Jul, 2021

Keywords

  • consistency
  • reliability
  • burden
  • response
  • methodology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-07-28.