Adverse Effect of Glucocorticoids and Synthetic AnaloguesPhase 4NCT01378689
Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids
A Phase 4 study testing Storytelling online video in people with Adverse Effect of Glucocorticoids and Synthetic Analogues and Osteoporosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This quality improvement project is aimed at improving health care by identifying low cost strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with their physicians about osteoporosis prevention and treatment (improving doctor-patient communication). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adverse Effect of Glucocorticoids and Synthetic Analogues, Osteoporosis, Rheumatoid Arthritis
- What is being tested?
- Storytelling online video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,659 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 5 milligrams of prednisone or glucocorticoid dose equivalent for greater than or equal to 90 days within the previous 12 months
- Medco member for entire study period
- Refill steroid prescription online
Who cannot join
- anti-osteoporosis medication in previous 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Improving Bone Health Among RA Patients on Chronic Glucocorticoids
This quality improvement project is aimed at improving health care by identifying low cost strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with their physicians about osteoporosis prevention and treatment (improving doctor-patient communication). The investigators will implement a direct to patient intervention to the population of interest (patients on chronic glucocorticoids) via story-telling, using an Internet based video. The target audience is people on chronic glucocorticoids not already receiving bones-specific osteoporosis medications to determine differences in post-intervention rates of osteoporosis care, and the rates of prescription anti-osteoporosis therapies.
- Conditions
- Adverse Effect of Glucocorticoids and Synthetic Analogues, Osteoporosis, Rheumatoid Arthritis
- Being tested
- Storytelling online video
- Medical subject headings
- Osteoporosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling online videoOther
patients with a history of chronic glucocorticoids use tell their experiences of side effects resulting from chronic use and provide advice on ways to prevent side effects
| Study group | Role | What they receive |
|---|---|---|
| Online video | Experimental | Participants in this arm are shown a brief video (~5 minutes) after ordering a refill for their glucocorticoid use. The video includes real patients telling their own story about the possible side effects of prolonged use of glucocorticoids. Receives: Other: Storytelling online video |
| No video | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants receiving Anti-osteoporosis Treatment
Includes bisphosphonates, PTH, SERM, Calcitonin
Measured: within 3 - 12 months of exposure to video
Secondary outcomes (2)
Calcium and Vitamin D use
Are participants taking calcium and vitamin d supplements
Measured: within 3 - 12 months of exposure to video
Patient-Physician Communication
Did viewing the video increase patient-physician communication
Measured: within 3 - 12 months of exposure to video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Effect of Glucocorticoids and Synthetic AnaloguesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,659 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Medco Health Services, Inc
- Responsible party
- Principal investigator, Kenneth Saag, MD, MSc, University of Alabama at Birmingham
- Investigators
- Kenneth G Saag, MD, MSc, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378689
- Sponsor's protocol ID
- X080529001
- Status last verified
- Jan 2013
- First submitted
- 16 Jun 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Warriner AH, Outman RC, Allison JJ, Curtis JR, Markward NJ, Redden DT, Safford MM, Stanek EJ, Steinkellner AR, Saag KG. An Internet-based Controlled Trial Aimed to Improve Osteoporosis Prevention among Chronic Glucocorticoid Users. J Rheumatol. 2015 Aug;42(8):1478-83. doi: 10.3899/jrheum.141238. Epub 2015 Jul 1.
PubMed 26136484
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Bone Health Among RA Patients on Chronic Glucocorticoids
- ClinicalTrials.gov ID
- NCT01378689
- Acronym / sponsor ID
- X080529001
- Conditions
- Adverse Effect of Glucocorticoids and Synthetic Analogues, Osteoporosis, Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,659 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Medco Health Services, Inc
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jun 2011 (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.
This quality improvement project is aimed at improving health care by identifying low cost strategies to get Rheumatoid Arthritis (RA) patients to more effectively communicate with their physicians about osteoporosis prevention and treatment (improving doctor-patient communication). The investigators will implement a direct to patient intervention to the population of interest (patients on chronic glucocorticoids) via story-telling, using an Internet based video. The target audience is people on chronic glucocorticoids not already receiving bones-specific osteoporosis medications to determine differences in post-intervention rates of osteoporosis care, and the rates of prescription anti-osteoporosis therapies.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online video | Experimental | Other: Storytelling online videoParticipants in this arm are shown a brief video (~5 minutes) after ordering a refill for their glucocorticoid use. The video includes real patients telling their own story about the possible side effects of prolonged use of glucocorticoids. |
| No video | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than or equal to 5 milligrams of prednisone or glucocorticoid dose equivalent for greater than or equal to 90 days within the previous 12 months
- Medco member for entire study period
- Refill steroid prescription online
Key exclusion criteria (1 listed)
- anti-osteoporosis medication in previous 12 months
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 |
|---|---|---|
| Storytelling online videopatients with a history of chronic glucocorticoids use tell their experiences of side effects resulting from chronic use and provide advice on ways to prevent side effects | Other | Online video |
Primary outcome
Number of participants receiving Anti-osteoporosis Treatment
Time frame: within 3 - 12 months of exposure to video
Includes bisphosphonates, PTH, SERM, Calcitonin
2 secondary outcomes
Calcium and Vitamin D use
Time frame: within 3 - 12 months of exposure to video
Patient-Physician Communication
Time frame: within 3 - 12 months of exposure to video
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Derived from this study: PubMed 26136484Warriner AH, Outman RC, Allison JJ, Curtis JR, Markward NJ, Redden DT, Safford MM, Stanek EJ, Steinkellner AR, Saag KG. An Internet-based Controlled Trial Aimed to Improve Osteoporosis Prevention among Chronic Glucocorticoid Users. J Rheumatol. 2015 Aug;42(8):1478-83. doi: 10.3899/jrheum.141238. Epub 2015 Jul 1.
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.
Kenneth G Saag, MD, MSc principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Storytelling online video in people with Adverse Effect of Glucocorticoids and Synthetic Analogues and Osteoporosis, run by University of Alabama at Birmingham 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jan 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants receiving Anti-osteoporosis Treatment (time frame: within 3 - 12 months of exposure to video). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378689, which also lists 1 linked publication.
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 16 Jan 2013.