Back to resultsImproving Osteoporosis Care in a Home Health Setting
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient magazine
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- prior fracture
- osteoporosis diagnosis
- received home health care
Exclusion Criteria:
- hospice
- active cancer treatment
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient Tailored Magazine
Arm Description
Patient responses from computer assisted telephone interviews will be used to develop a patient tailored educational magazine.
Outcomes
Primary Outcome Measures
Initiation/Maintenance of Anti-osteoporosis prescription medication
Secondary Outcome Measures
Initiation/Maintenance of calcium and vitamin D
Full Information
NCT ID
NCT01109472
First Posted
April 21, 2010
Last Updated
December 20, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
Eli Lilly and Company, Alacare Home Health and Hospice
1. Study Identification
Unique Protocol Identification Number
NCT01109472
Brief Title
Improving Osteoporosis Care in a Home Health Setting
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Eli Lilly and Company, Alacare Home Health and Hospice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1009 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Tailored Magazine
Arm Type
Experimental
Arm Description
Patient responses from computer assisted telephone interviews will be used to develop a patient tailored educational magazine.
Intervention Type
Other
Intervention Name(s)
patient magazine
Intervention Description
patient magazine individually tailored to patient's prior feedback
Primary Outcome Measure Information:
Title
Initiation/Maintenance of Anti-osteoporosis prescription medication
Time Frame
Three months post initial survey
Secondary Outcome Measure Information:
Title
Initiation/Maintenance of calcium and vitamin D
Time Frame
Three months post initial survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prior fracture
osteoporosis diagnosis
received home health care
Exclusion Criteria:
hospice
active cancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey R Curtis, MD, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Improving Osteoporosis Care in a Home Health Setting
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