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Limb Loss Self-Management Program

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164502
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Limb Loss Self-Management Program: "Promoting Amputee Life Skills"

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

ClinicalTrials.gov processed this record on November 27, 2014