Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
NCT02326532
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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 |
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| Study Arms ICMJE |
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| 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 | 143 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
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| Investigators ICMJE |
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| 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 | ||||