OsteoporosisNCT01112098
Improving Quality of Osteoporosis Care Through Patient Storytelling
A study testing Patient Pamphlet in people with Osteoporosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient intervention materials (i.e., a personalized letter and osteoporosis information pamphlet) designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve osteoporosis quality of care. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Patient Pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,997 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Apr 2011
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female
- Age 65 or older
- At least one visit with a primary care physician in the previous 12 months
Who cannot join
- DXA scan in the previous 5 years
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: Randomized Trial of a Mailed Intervention and Self-Scheduling to Improve Osteoporosis Screening in Postmenopausal Women
The purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient intervention materials (i.e., a personalized letter and osteoporosis information pamphlet) designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve osteoporosis quality of care.
Read the detailed description
While the occurrence of a fragility fracture (e.g. hip fracture) is indicative of low BMD and a clinical diagnosis of osteoporosis made, osteoporosis can be identified in asymptomatic patients using dual energy x-ray absorptiometry (DXA). United States (U.S.) guidelines recommend screening bone density tests using central DXA in all women 65 years or older. However, fewer than one-third of eligible U.S. women age 65 and older undergo DXA testing. The main barrier to achieving greater rates of osteoporosis screening is identifying a systematic, effective, and generalizable way for healthcare providers and patients to schedule DXA results.
Given that national guidelines recommend DXA screening for all older women, the reasons a majority of women do not receive DXA testing are likely multifactorial. Patients and their health care providers may be unaware of preventative screening recommendations and the reasons for these recommendations. Screening tests that are required relatively infrequently (i.e. less than once a year) may be difficult for patients and physicians to remember if there are few triggers (e.g. seasonality as a trigger to motivate influenza vaccination). Additionally, primary care providers (PCPs) are responsible for managing a large number of comorbidities and acute care needs and may be unable to stay current with all preventative care needs during increasingly short clinic visits.
- Conditions
- Osteoporosis
- Being tested
- Patient Pamphlet
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient PamphletBehavioural
Also called Educational Materials, Written Materials, Mailed Letter
letter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan
| Study group | Role | What they receive |
|---|---|---|
| Educational Pamphlet and letter | Experimental | Letter invites patient to self-schedule a DXA; educational pamphlet includes information about DXA scans Receives: Behavioral: Patient Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
DXA scheduled
Patient scheduled a DXA within 6 months of receiving intervention materials
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionApr 2011
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 OsteoporosisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Investigators
- Jeffrey R Curtis, MD, MPH, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112098
- Sponsor's protocol ID
- X070502003
- Status last verified
- May 2011
- First submitted
- 26 Apr 2010
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Warriner AH, Outman RC, Kitchin E, Chen L, Morgan S, Saag KG, Curtis JR. A randomized trial of a mailed intervention and self-scheduling to improve osteoporosis screening in postmenopausal women. J Bone Miner Res. 2012 Dec;27(12):2603-10. doi: 10.1002/jbmr.1720.
PubMed 22836812
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Mailed Intervention and Self-Scheduling to Improve Osteoporosis Screening in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01112098
- Acronym / sponsor ID
- X070502003
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,997 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 28 Apr 2010 (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 purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient intervention materials (i.e., a personalized letter and osteoporosis information pamphlet) designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve osteoporosis quality of care.
Detailed description
While the occurrence of a fragility fracture (e.g. hip fracture) is indicative of low BMD and a clinical diagnosis of osteoporosis made, osteoporosis can be identified in asymptomatic patients using dual energy x-ray absorptiometry (DXA). United States (U.S.) guidelines recommend screening bone density tests using central DXA in all women 65 years or older. However, fewer than one-third of eligible U.S. women age 65 and older undergo DXA testing. The main barrier to achieving greater rates of osteoporosis screening is identifying a systematic, effective, and generalizable way for healthcare providers and patients to schedule DXA results.
Given that national guidelines recommend DXA screening for all older women, the reasons a majority of women do not receive DXA testing are likely multifactorial. Patients and their health care providers may be unaware of preventative screening recommendations and the reasons for these recommendations. Screening tests that are required relatively infrequently (i.e. less than once a year) may be difficult for patients and physicians to remember if there are few triggers (e.g. seasonality as a trigger to motivate influenza vaccination). Additionally, primary care providers (PCPs) are responsible for managing a large number of comorbidities and acute care needs and may be unable to stay current with all preventative care needs during increasingly short clinic visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Pamphlet and letter | Experimental | Behavioral: Patient PamphletLetter invites patient to self-schedule a DXA; educational pamphlet includes information about DXA scans |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Female
- Age 65 or older
- At least one visit with a primary care physician in the previous 12 months
Key exclusion criteria (1 listed)
- DXA scan in the previous 5 years
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 |
|---|---|---|
| Patient PamphletAlso: Educational Materials, Written Materials, Mailed Letterletter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan | Behavioural | Educational Pamphlet and letter |
Primary outcome
DXA scheduled
Time frame: 6 months
Patient scheduled a DXA within 6 months of receiving intervention materials
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 10 May 2011.
- Derived from this study: PubMed 22836812Warriner AH, Outman RC, Kitchin E, Chen L, Morgan S, Saag KG, Curtis JR. A randomized trial of a mailed intervention and self-scheduling to improve osteoporosis screening in postmenopausal women. J Bone Miner Res. 2012 Dec;27(12):2603-10. doi: 10.1002/jbmr.1720.
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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.
Jeffrey R Curtis, MD, MPH, MS 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 study testing Patient Pamphlet in people with 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 10 May 2011. 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.
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?
DXA scheduled (time frame: 6 months). 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 NCT01112098, 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 10 May 2011.