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Limb Loss Self-Management Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00164502
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centers for Disease Control and Prevention
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 or older congenital or acquired limb loss

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00164502     History of Changes
Other Study ID Numbers: CDC-NCBDDD-CCR322981
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005