Limb Loss Self-Management Program | NCT00164502

Studies
Limb Loss Self-Management Program

NCT00164502

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Sep 14, 2005Estimated

Enrollment

500

Phase

Phase 2

Conditions

Congenital or Acquired Limb Deficiency

Interventions

Community-based eight session group 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

Status Module

Record Verification Date

Sep 2005

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

Oct 2003

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 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

Sep 12, 2005

Last Update Posted Date

Sep 14, 2005Estimated

Description Module

Brief Summary

The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and improving self-efficacy and function in person with limb loss

Detailed Description

Approximately 1.2 million Americans are living with the loss of a limb and the incidence is increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced functional abilities are common conditions following limb loss and reduce quality of life. Self-management interventions have been found to be effective in reducing the secondary conditions associated with arthritis and diabetes. Self management uses the principles of cognitive-behavioral therapy including education, self monitoring, problem solving, and skill acquisition.

The goal of the project is to develop and test the efficacy of a community based self management intervention for reducing pain, depression, and improving self efficacy and function in persons with limb loss using a randomized controlled design.

50 groups of 8-10 persons will be randomized to either a control group or a treatment group.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500

Name	Type	Description	Arm Group Labels	Other Names
Community-based eight session group self-management program	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
self-reported pain
depressed mood
positive affect

Secondary Outcomes

Measure	Description	Time Frame
increase in activities and participation
improved quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 or older congenital or acquired limb loss

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen MacKenzie, Ph.D.	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Puget Sound Health Services		Seattle	Washington	98108	United States