Analyzing Orthopedic Patient Experience Patterns in Medical Trials

December 29, 2023 updated by: Power Life Sciences Inc.

A Comprehensive Study for Analyzing Orthopedic Patient Experience Patterns in Medical Trials

Clinical study enrollment has historically been heavily biased toward specific demographics.

Several people will be invited to participate in this study so that it may collect a variety of data about orthopedic clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with orthopedic disorders who are invited to take part in medical research will benefit from the analysis of the data.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Orthopedic disorder patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.

Description

Inclusion Criteria:

  • Patient has been diagnosed with orthopedic disorder
  • Patient has self-identified as planning to enroll in an interventional clinical trial
  • Patient is 18 years old

Exclusion Criteria:

  • ECOG score of 4
  • Patient is pregnant
  • Inability to perform regular electronic reporting
  • Patient does not understand, sign, and return consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who decide to enroll in an orthopedic clinical trial
Time Frame: 3 months
3 months
Rate of patients who remain in orthopedic clinical trial to trial completion
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Power Life Sciences Inc.

Investigators

  • Study Director: Michael B Gill, Power Life Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 29, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86809840

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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