NCT02326532

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
143

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

6.3 years

First QC Date

December 9, 2014

Last Update Submit

September 8, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisVeterans

Outcome Measures

Primary Outcomes (1)

  • physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.

    Physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.

    1 year

Secondary Outcomes (2)

  • patient satisfaction

    1 year

  • medication compliance

    1 year

Study Arms (2)

PRO data utilized

EXPERIMENTAL

PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm and provided to the treating physicians.

Other: PRO data utilized

PRO data not utilized

SHAM COMPARATOR

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.

Other: PRO data not utilized

Interventions

PRO data utilizedOTHER

Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.

PRO data utilized
PRO data not utilizedOTHER

Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.

PRO data not utilized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Outside of service network
  • Non-veteran

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malcom Randall VAMC

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michael R Bubb, MD

    Veterans Health Administration, University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 29, 2014

Study Start

February 1, 2015

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

US(1)