Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures
NCT ID: NCT04008680
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2021-05-17
2022-12-31
Brief Summary
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Detailed Description
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The secondary objective is to evaluate how the number of questionnaires and the time it takes to complete them impact patient's preferences and values. We will measure the time taken by each participant to complete the EQ-5D-5L questionnaire to evaluate if it changes meaningfully as the number of questionnaires given to participants' increases. Additionally, we will assess patient preferences and values by asking how well the remotely collected PROMs reflect their health status, and how this changes relative to the number of questionnaires administered.
Our hypothesis is that there is a progressive decline in psychometric properties in the EQ-5D-5L, both in reliability and validity, as we increase the number of questionnaires given to participants. We also hypothesize that the time to complete the ED-5D-5L will increase as the number of questionnaires given to participants' increases, and that there is a threshold at which the patient feels there are no additional value to completing additional remote PROMS to adequately reflect their health status.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Low response burden
Participants will be assigned to complete only the EQ-5D-5L questionnaire.
EQ-5D-5L survey internal consistency
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
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.
EQ-5D-5L survey internal consistency
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
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.
EQ-5D-5L survey internal consistency
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
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.
EQ-5D-5L survey internal consistency
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
Interventions
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EQ-5D-5L survey internal consistency
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Francesc Antoni Marcano-Fernandez, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Herman Johal, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Hamilton Health Sciences - General Site
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HiREB 7607
Identifier Type: -
Identifier Source: org_study_id
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