NCT01109472

Brief Summary

Study aims to improve osteoporosis care through patient tailored education materials in a group-randomized trial of patients referred to home health care with a history of fracture and/or an osteoporosis diagnosis. Project investigators will conduct telephone surveys and examine electronic medical record data to assess fracture related morbidity and mortality, osteoporosis treatment and adherence, and use of calcium and vitamin D supplements. We hypothesize that patients that receive the intervention materials will be more likely to initiate or maintain osteoporosis treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,009

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

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

April 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 23, 2013

Status Verified

December 1, 2013

Enrollment Period

3.3 years

First QC Date

April 21, 2010

Last Update Submit

December 20, 2013

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Initiation/Maintenance of Anti-osteoporosis prescription medication

    Three months post initial survey

Secondary Outcomes (1)

  • Initiation/Maintenance of calcium and vitamin D

    Three months post initial survey

Study Arms (1)

Patient Tailored Magazine

EXPERIMENTAL

Patient responses from computer assisted telephone interviews will be used to develop a patient tailored educational magazine.

Other: patient magazine

Interventions

patient magazineOTHER

patient magazine individually tailored to patient's prior feedback

Patient Tailored Magazine

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • prior fracture
  • osteoporosis diagnosis
  • received home health care

You may not qualify if:

  • hospice
  • active cancer treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jeffrey R Curtis, MD, MPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2010

First Posted

April 23, 2010

Study Start

April 1, 2009

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

December 23, 2013

Record last verified: 2013-12