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Improving Osteoporosis Care in a Home Health Setting

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ClinicalTrials.gov Identifier: NCT01109472
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : December 23, 2013
Sponsor:
Collaborators:
Eli Lilly and Company
Alacare Home Health and Hospice
Information provided by (Responsible Party):
Jeff Curtis, MD, University of Alabama at Birmingham

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.


Condition or disease Intervention/treatment Phase
Osteoporosis Other: patient magazine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1009 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : April 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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

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 Posted: April 23, 2010    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: December 2013

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