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Low to medium response burden for Patient-Reported Outcome Measures (PROMs) (CRAM-PROMs Trial)

N/A

Waitlist Available

Led By Herman Johal, MD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

CRAM-PROMs Trial Summary

This trial looks at how different numbers of questionnaires can affect how reliable patient reported outcomes are.

CRAM-PROMs Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Time to completion

CRAM-PROMs Trial Design

4Treatment groups

Experimental Treatment

Group I: Medium to high response burdenExperimental Treatment1 Intervention

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.

Group II: Low to medium response burdenExperimental Treatment1 Intervention

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

Group III: Low response burdenExperimental Treatment1 Intervention

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

Group IV: High response burdenExperimental Treatment1 Intervention

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.

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Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,891 Total Patients Enrolled

Herman Johal, MDPrincipal InvestigatorMcMaster University

1 Previous Clinical Trials

100 Total Patients Enrolled

Francesc Antoni Marcano-Fernandez, PhDPrincipal InvestigatorMcMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are in the current research project?

"Indeed, the clinicaltrials.gov website indicates that this research is actively seeking applicants. The trial was initiated on May 17th 2021 and its parameters were most recently modified in July 26th 2021. 110 volunteers are needed to be enrolled at a single medical site."

Answered by AI

Are there vacancies for participants of this experiment?

"Affirmative. Clinicaltrials.gov information points to this medical trial being actively recruiting participants, with the initial posting on May 17th 2021 and last update occurring July 26th 2021. At present, 110 patients are needed across a single location for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures

2021. "Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04008680.