Improving Osteoporosis Care in a Home Health Setting

December 20, 2013 updated by: Jeff Curtis, MD, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1009

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • prior fracture
  • osteoporosis diagnosis
  • received home health care

Exclusion Criteria:

  • hospice
  • active cancer treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Tailored Magazine
Patient responses from computer assisted telephone interviews will be used to develop a patient tailored educational magazine.
Other: patient magazine
patient magazine individually tailored to patient's prior feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Initiation/Maintenance of Anti-osteoporosis prescription medication
Time Frame: Three months post initial survey
Three months post initial survey

Secondary Outcome Measures

Outcome Measure
Time Frame
Initiation/Maintenance of calcium and vitamin D
Time Frame: Three months post initial survey
Three months post initial survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Eli Lilly and Company
Alacare Home Health and Hospice

Investigators

  • Principal Investigator: Jeffrey R Curtis, MD, MPH, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 23, 2010

Study Record Updates

Last Update Posted (Estimate)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X080401004
  • B3D-US-X016 (Other Grant/Funding Number: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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