Limb Loss Self-Management Program - Full Text View

Purpose

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

Condition	Intervention	Phase
Congenital or Acquired Limb Deficiency	Behavioral: Community-based eight session group self-management program	Phase II

MedlinePlus related topics:

Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	Limb Loss Self-Management Program: "Promoting Amputee Life Skills"

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

self-reported pain
depressed mood
positive affect

Secondary Outcome Measures:

increase in activities and participation
improved quality of life

Estimated Enrollment:	500
Study Start Date:	October 2003
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 18 or older congenital or acquired limb loss

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164502

Locations


United States, Washington
	Puget Sound Health Services
	Seattle, Washington, United States, 98108

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators


Principal Investigator:	Ellen MacKenzie, Ph.D.	Johns Hopkins University

More Information

Study ID Numbers:	CDC-NCBDDD-CCR322981
First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00164502
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on October 23, 2008

Sponsored by:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164502