PROMCRAM-PROMsNCT04008680
Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures
A study testing EQ-5D-5L survey internal consistency in people with PROM, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PROM
- What is being tested?
- EQ-5D-5L survey internal consistency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 17 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences - General Site
Hamilton, Ontario
Gina Del Fabbro, BPH, 2898080709, delfabbg@mcmaster.ca
Jodi Gallant, gallaj4@mcmaster.ca
About this study
Official title: Collection of Remotely Administered Multiple Patient-Reported Outcome Measures (CRAM-PROMs) in Orthopaedic Trauma: Assessment of the Impact of Quantity on Quality
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.
Read the detailed description
The primary objective of the study is to determine if the number of remotely administered questionnaires completed by fracture patients affects the psychometric properties of a questionnaire itself. We will assess the internal consistency of the EuroQuol Five Dimension - Five Level (EQ-5D-5L) Health Survey questionnaire as more questionnaires are applied.
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
- PROM
- Being tested
- EQ-5D-5L survey internal consistency
- Keywords
- consistency, reliability, burden, response, methodology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ-5D-5L survey internal consistencyOther
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
| Study group | Role | What they receive |
|---|---|---|
| Low response burden | Other | Participants will be assigned to complete only the EQ-5D-5L questionnaire. Receives: 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. Receives: 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. Receives: 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. Receives: Other: EQ-5D-5L survey internal consistency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Time to completion
Time to complete the questionnaire. We will collect data (through electronic software) on time to completion of the EQ-5D-5L questionnaire. We hypothesize that as patients are asked to complete more surveys, patients will fatigue as the research burden increases and take longer to complete the surveys. Data will be collected in minutes, and the mean time to completion will be compared across groups through analysis of variance tests.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start17 May 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 group randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesc Antoni Marcano-Fernandez, PhD, Principal investigator, McMaster UniversityHerman Johal, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008680
- Sponsor's protocol ID
- HiREB 7607
- Acronym
- CRAM-PROMs
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided. Data collected (Internal consistency, demographics etc will be shared previous agreement)
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Remotely Administered Multiple Patient-Reported Outcome Measures (CRAM-PROMs) in Orthopaedic Trauma: Assessment of the Impact of Quantity on Quality
- ClinicalTrials.gov ID
- NCT04008680
- Acronym / sponsor ID
- CRAM-PROMs / HiREB 7607
- Conditions
- PROM
- Keywords
- consistency, reliability, burden, response, methodology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Jul 2019 (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.
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.
Detailed description
The primary objective of the study is to determine if the number of remotely administered questionnaires completed by fracture patients affects the psychometric properties of a questionnaire itself. We will assess the internal consistency of the EuroQuol Five Dimension - Five Level (EQ-5D-5L) Health Survey questionnaire as more questionnaires are applied.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 group randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Low response burden | Other | Other: EQ-5D-5L survey internal consistencyParticipants will be assigned to complete only the EQ-5D-5L questionnaire. |
| Low to medium response burden | Other | Other: EQ-5D-5L survey internal consistencyParticipants will be assigned to complete the General Anxiety Disorder-7 (GAD-7) questionnaire first, followed by the EQ-5D-5L questionnaire. |
| Medium to high response burden | Other | Other: EQ-5D-5L survey internal consistencyParticipants will be assigned to complete the Pain Catastrophizing Scale (PCS) questionnaire first, followed by the GAD-7, and lastly the EQ-5D-5L questionnaire. |
| High response burden | Other | Other: EQ-5D-5L survey internal consistencyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQ-5D-5L survey internal consistencyTo see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L. | Other | High response burden, Low response burden, Low to medium response burden, Medium to high response burden |
Primary outcome
Reliability and validity of the EQ-5D-5L
Time frame: Day 1
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.
1 secondary outcome
Time to completion
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No. Undecided. Data collected (Internal consistency, demographics etc will be shared previous agreement)
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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.
Francesc Antoni Marcano-Fernandez, PhD principal investigator
McMaster University
Herman Johal, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQ-5D-5L survey internal consistency in people with PROM, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gina Del Fabbro, BPH (2898080709, delfabbg@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and validity of the EQ-5D-5L (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.