Improving Osteoporosis Care in a Home Health Setting

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Alacare Home Health and Hospice
Information provided by (Responsible Party):
Jeff Curtis, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01109472
First received: April 21, 2010
Last updated: December 20, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Initiation/Maintenance of Anti-osteoporosis prescription medication [ Time Frame: Three months post initial survey ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Initiation/Maintenance of calcium and vitamin D [ Time Frame: Three months post initial survey ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prior fracture
  • osteoporosis diagnosis
  • received home health care

Exclusion Criteria:

  • hospice
  • active cancer treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 21, 2010
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014