Improving Osteoporosis Care in a Home Health Setting | NCT01109472

Studies
Improving Osteoporosis Care in a Home Health Setting

NCT01109472

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Dec 23, 2013Estimated

Enrollment

1,009Actual

Phase

Not Applicable

Conditions

Osteoporosis

Interventions

patient magazine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
B3D-US-X016	Other Grant/Funding Number	Eli Lilly and Company

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Apr 21, 2010

First Submission Date that Met QC Criteria

Apr 21, 2010

First Posted Date

Apr 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2013

Last Update Posted Date

Dec 23, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeff Curtis, MD, Principal Investigator, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Name	Class
Eli Lilly and Company	INDUSTRY
Alacare Home Health and Hospice	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,009Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient Tailored Magazine	Experimental	Patient responses from computer assisted telephone interviews will be used to develop a patient tailored educational magazine.	Other: patient magazine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patient magazine	Other	patient magazine individually tailored to patient's prior feedback	Patient Tailored Magazine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

prior fracture
osteoporosis diagnosis
received home health care

Exclusion Criteria:

hospice
active cancer treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey R Curtis, MD, MPH	University of Alabama at Birmingham	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided