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Improving Patient Outcomes for Shoulder Pain

N/A
Recruiting
Led By Nikhil Verma, MD
Research Sponsored by Rush University Medical Center
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 change in pro compliance rate between pre-surgery and 1-year post surgery
Awards & highlights

Study Summary

This trial is looking at ways to improve how often patients fill out forms about their health (PRO forms).

Who is the study for?
This trial is for adults under 80 who are fluent in English and scheduled for shoulder surgery to treat rotator cuff conditions. It's not suitable for minors, those over 80, or patients with medical histories that prevent safe surgery.Check my eligibility
What is being tested?
The study explores ways to improve patient completion rates of self-reported outcome surveys. Interventions include email reminders, discussions before and after surgery, and incentives for completing the surveys.See study design
What are the potential side effects?
Since this trial focuses on survey completion rather than medication or invasive procedures, there are no direct side effects related to traditional clinical interventions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in pro compliance rate between pre-surgery and 1-year post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in pro compliance rate between pre-surgery and 1-year post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Does patient engagement, through education or monetary incentivization, increase PRO compliance rate at 1 year after surgery, when compared to PRO compliance rate before surgery?
Secondary outcome measures
Effects of English proficiency on PRO compliance rate.
Effects of age on PRO compliance rate.
Effects of technological literacy on PRO compliance rate.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Pre- and post-operative discussion groupExperimental Treatment2 Interventions
Patients will discuss with their care provider their health outcomes before and at 6-months after their surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.
Group II: Incentivised groupExperimental Treatment2 Interventions
Patients will receive up to $30 in amazon gift cards as an incentive if they complete their forms before surgery, as well as at 6-months and 1-year after surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.
Group III: Control groupExperimental Treatment1 Intervention
Patients will only receive email reminders to complete their forms, if they haven't done so.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Incentive
2008
Completed Phase 3
~67070

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,101 Total Patients Enrolled
1 Trials studying Shoulder Pain
American Orthopaedic Society for Sports MedicineOTHER
6 Previous Clinical Trials
857 Total Patients Enrolled
Nikhil Verma, MDPrincipal InvestigatorRush University Medical Center

Media Library

Email reminders Clinical Trial Eligibility Overview. Trial Name: NCT03653455 — N/A
Shoulder Pain Research Study Groups: Control group, Incentivised group, Pre- and post-operative discussion group
Shoulder Pain Clinical Trial 2023: Email reminders Highlights & Side Effects. Trial Name: NCT03653455 — N/A
Email reminders 2023 Treatment Timeline for Medical Study. Trial Name: NCT03653455 — N/A

Frequently Asked Questions

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

Are applicants of at least twenty years of age eligible for this trial?

"Eligibility requirements for this clinical trial stipulate that participants should be aged between 18 and 80. Exceptions can be made for those under the age of 18 or over 65, as there are 3 studies designed specifically to cater to them respectively."

Answered by AI

Are there still opportunities for enrollment in this experiment?

"Affirmative. According to the details hosted on clinicaltrials.gov, this study is presently recruiting patients - it was first published online on April 30th 2019 and underwent its most recent update on June 30th 2022. It requires a total of 400 participants from 1 medical centre."

Answered by AI

How many individuals are currently receiving treatment as part of this research project?

"Affirmative. According to the information held on clinicaltrials.gov, this trial is still enrolling candidates and was first advertised on April 30th 2019. The investigation requires 400 patients from a single site with it's last update occuring June 30th 2022."

Answered by AI

Who would be an eligible participant in this clinical study?

"This medical trial is recruiting 400 individuals between the age of 18 and 80 who currently experience shoulder soreness. Furthermore, they must be due to have a rotator cuff condition (sub-acromial decompression, distal clavicle resection, biceps tenodesis, partial or full thickness rotator cuff tear repair or debridement) addressed through arthroscopic surgery that does not conflict with any exclusion criteria."

Answered by AI
~47 spots leftby Dec 2024