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Improving Osteoporosis Care in a Home Health Setting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109472
First Posted: April 23, 2010
Last Update Posted: December 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eli Lilly and Company
Alacare Home Health and Hospice
Information provided by (Responsible Party):
Jeff Curtis, MD, University of Alabama at Birmingham
  Purpose

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.


Condition Intervention
Osteoporosis Other: patient magazine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Jeff Curtis, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Initiation/Maintenance of Anti-osteoporosis prescription medication [ Time Frame: Three months post initial survey ]

Secondary Outcome Measures:
  • Initiation/Maintenance of calcium and vitamin D [ Time Frame: Three months post initial survey ]

Enrollment: 1009
Study Start Date: April 2009
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prior fracture
  • osteoporosis diagnosis
  • received home health care

Exclusion Criteria:

  • hospice
  • active cancer treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109472


Sponsors and Collaborators
University of Alabama at Birmingham
Eli Lilly and Company
Alacare Home Health and Hospice
Investigators
Principal Investigator: Jeffrey R Curtis, MD, MPH University of Alabama at Birmingham
  More Information

Responsible Party: Jeff Curtis, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01109472     History of Changes
Other Study ID Numbers: X080401004
B3D-US-X016 ( Other Grant/Funding Number: Eli Lilly and Company )
First Submitted: April 21, 2010
First Posted: April 23, 2010
Last Update Posted: December 23, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases