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Limb Loss Self-Management Program

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ClinicalTrials.gov Identifier: NCT00164502
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Sponsor:
Information provided by:
Centers for Disease Control and Prevention

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

Condition or disease Intervention/treatment Phase
Congenital or Acquired Limb Deficiency Behavioral: Community-based eight session group self-management program Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
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"
Study Start Date : October 2003
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss
U.S. FDA Resources




Primary Outcome Measures :
  1. self-reported pain
  2. depressed mood
  3. positive affect

Secondary Outcome Measures :
  1. increase in activities and participation
  2. improved quality of life


Information from the National Library of Medicine

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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:


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

ClinicalTrials.gov Identifier: NCT00164502     History of Changes
Other Study ID Numbers: CDC-NCBDDD-CCR322981
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005