Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis

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NCT02326532

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Study Location
Malcom Randall VAMC
Gainesville, Florida, 32608, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- US veteran

- Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Outside of service network


- Non-veteran

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Advanced Information
Descriptive Information
Brief Title  ICMJE Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
Official Title  ICMJE Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
Brief Summary The overall goal of this proposal is to address barriers to the use of patient reported outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.
Detailed Description This is a randomized, controlled, single-blinded study that compares outcome data in patients for whom PRO data either is or is not made available to the treating physician. The question addressed by this proposal is whether patient reported outcome (PRO) data change patient's outcomes. The hypothesis is that the availability of these data in the form of the patient-completed Multidimensional Health Assessment Questionnaire/routine assessment of patient index data (MDHAQ/RAPID3) questionnaire will change patient-centric outcomes such as patient reported well-being, patient satisfaction and medication compliance.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Other: PRO data utilized
    Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
  • Other: PRO data not utilized
    Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.
Study Arms  ICMJE
  • Experimental: PRO data utilized
    PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm and provided to the treating physicians.
    Intervention: Other: PRO data utilized
  • Sham Comparator: PRO data not utilized
    PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm but will not be provided to the treating physicians.
    Intervention: Other: PRO data not utilized
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 27, 2017)		143
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2014)		180
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • US veteran
  • Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network

Exclusion Criteria:

  • Outside of service network
  • Non-veteran
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326532
Other Study ID Numbers  ICMJE IRB2014002 18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party North Florida Foundation for Research and Education
Study Sponsor  ICMJE North Florida Foundation for Research and Education
Collaborators  ICMJE
  • Pfizer
  • US Department of Veterans Affairs
Investigators  ICMJE
Principal Investigator:Michael R Bubb, MDVeterans Health Administration, University of Florida
PRS Account North Florida Foundation for Research and Education
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP