NCT01112098

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,997

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

2.4 years

First QC Date

April 26, 2010

Last Update Submit

May 6, 2011

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • DXA scheduled

    Patient scheduled a DXA within 6 months of receiving intervention materials

    6 months

Study Arms (1)

Educational Pamphlet and letter

EXPERIMENTAL

Letter invites patient to self-schedule a DXA; educational pamphlet includes information about DXA scans

Behavioral: Patient Pamphlet

Interventions

Patient PamphletBEHAVIORAL

letter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan

Also known as: Educational Materials, Written Materials, Mailed Letter
Educational Pamphlet and letter

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Female
  • Age 65 or older
  • At least one visit with a primary care physician in the previous 12 months

You may not qualify if:

  • DXA scan in the previous 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 22836812DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jeffrey R Curtis, MD, MPH, MS

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

April 1, 2011

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations

US(1)