Telephone Interview Study for Men and Women With Osteoart... | NCT01680445

Studies
Telephone Interview Study for Men and Women With Osteoarthritis

NCT01680445

Sponsor

Health Outcomes Solutions

Status

Completed

Last Update Posted

Sep 7, 2012Estimated

Enrollment

23Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

United States

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

Status Module

Record Verification Date

Sep 2012

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

Mar 2011

Primary Completion Date

Apr 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Oct 9, 2011

First Submission Date that Met QC Criteria

Sep 4, 2012

First Posted Date

Sep 7, 2012Estimated

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

Sep 4, 2012

Last Update Posted Date

Sep 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The telephone interviews will be conducted to gather information on goal setting and goal attainment from men and women with osteoarthritis.

Detailed Description

Interview data used to develop a new self-administered questionnaire

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 40 and 80 years of age
Have moderate to severe pain
Diagnosed with osteoarthritis of the hip and/or knee at least 6 months ago
Currently receiving treatment for osteoarthritis
Able to speak and read English
US resident
Willing to share your thoughts and experiences in a 45-minute telephone interview

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

US residents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Mathias	Health Outcomes Solutions	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Outcomes Solutions		Winter Park	Florida	32790	United States

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D007592	Joint Diseases

Ancestor Terms

ID	Term
D001168	Arthritis
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided