Comparing ASHC and CDSMP Outcomes In Arthritis | NCT00207441

Studies
Comparing ASHC and CDSMP Outcomes In Arthritis

NCT00207441

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Mar 24, 2011Estimated

Enrollment

416Actual

Phase

Not Applicable

Conditions

Arthritis

Interventions

Arthritis Self management program
Chronic Disease Self Management Program

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

ID	Type	Description	Link
S2233-22/23

Status Module

Record Verification Date

Mar 2011

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 2003

Primary Completion Date

Oct 2004Actual

Completion Date

Aug 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

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

Mar 23, 2011

Last Update Posted Date

Mar 24, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centers for Disease Control and PreventionFED

Collaborators

Name	Class
University of North Carolina, Chapel Hill	OTHER
East Carolina University	OTHER

Description Module

Brief Summary

The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural counties in North Carolina. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.

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

416Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arthritis self management program	Experimental		Behavioral: Arthritis Self management program
Chronic Disease Self Management Program	Experimental		Behavioral: Chronic Disease Self Management Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arthritis Self management program	Behavioral		Arthritis self management program	ASHC AFSMP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health related quality of life, measured at 4 and 12 months,		4 months, 12 months
Health care utilization measured at 4 and 12 months		4 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
Self management behaviors measured at 4 and 12 months		4 months, 12 months
Self efficacy for arthritis management, measured at 4 and 12 months		4 months, 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

African american adults with arthritis Caucasian adults with arthritis

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Jean Goeppinger, PhD RN	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Craven County Health Department		New Bern	North Carolina	28561	United States

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis
D002908	Chronic Disease

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided