Rheumatoid ArthritisPRONCT02326532
Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
A study testing PRO data utilized and PRO data not utilized in people with Rheumatoid Arthritis, run by North Florida Foundation for Research and Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- PRO data utilized and PRO data not utilized
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- US veteran
- Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network
Who cannot join
- Outside of service network
- Non-veteran
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- PRO data utilized, PRO data not utilized
- Keywords
- Rheumatoid Arthritis, Veterans
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO data utilizedOther
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
PRO data not utilizedOther
Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PRO data not utilized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
patient satisfaction
Patient reported satisfaction with medical care. A validated patient satisfaction survey will be collected at study completion with the Leeds Satisfaction Questionnaire.
Measured: 1 year
medication compliance
Degree of medication compliance. Medication compliance will be assessed by the medication possession ratio (MPR) of Methotrexate (MTX), a drug most Rheumatoid Arthritis (RA) patients are prescribed. The VA Pharmacy Benefits Management (PBM) database collects information on medications dispensed and when refills are needed. Thus, a delay in refill will reflect MTX non-compliance. If it MTX is discontinued due to an adverse reaction, it is noted in the electronic medical record. The MPR is calculated as the number of days of prescribed MTX divided by the total number of days of a course.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Florida Foundation for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Michael R Bubb, MD, Principal investigator, Veterans Health Administration, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326532
- Sponsor's protocol ID
- IRB2014002 18
- Acronym
- PRO
- Status last verified
- Sep 2020
- First submitted
- 9 Dec 2014
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02326532
- Acronym / sponsor ID
- PRO / IRB2014002 18
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Veterans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (actual)
- Lead sponsor
- North Florida Foundation for Research and EducationUniversity, hospital or other
- Collaborators
- Pfizer, US Department of Veterans Affairs
- Study start
- Feb 2015
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRO data utilized | Experimental | Other: PRO data utilizedPRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm and provided to the treating physicians. |
| PRO data not utilized | Sham comparator | Other: PRO data not utilizedPRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm but will not be provided to the treating physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- US veteran
- Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network
Key exclusion criteria (2 listed)
- Outside of service network
- Non-veteran
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO data utilizedData collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician. | Other | PRO data utilized |
| PRO data not utilizedData collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician. | Other | PRO data not utilized |
Primary outcome
physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
Time frame: 1 year
Physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.
2 secondary outcomes
patient satisfaction
Time frame: 1 year
medication compliance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Bubb, MD principal investigator
Veterans Health Administration, University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRO data utilized and PRO data not utilized in people with Rheumatoid Arthritis, run by North Florida Foundation for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.