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Clinical Trials/NCT00164502
NCT00164502
Completed
Phase 2

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

Centers for Disease Control and Prevention1 site in 1 country500 target enrollmentOctober 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Congenital or Acquired Limb Deficiency
Sponsor
Centers for Disease Control and Prevention
Enrollment
500
Locations
1
Primary Endpoint
self-reported pain
Status
Completed
Last Updated
20 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
June 2005
Last Updated
20 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • age 18 or older congenital or acquired limb loss

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

self-reported pain

positive affect

depressed mood

Secondary Outcomes

  • increase in activities and participation
  • improved quality of life

Study Sites (1)

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