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
|Condition or disease||Intervention/treatment||Phase|
|Congenital or Acquired Limb Deficiency||Behavioral: Community-based eight session group self-management program||Phase 2|
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)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Limb Loss Self-Management Program: "Promoting Amputee Life Skills"|
|Study Start Date :||October 2003|
|Estimated Study Completion Date :||June 2005|
- self-reported pain
- depressed mood
- positive affect
- increase in activities and participation
- improved quality of life
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
|United States, Washington|
|Puget Sound Health Services|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Ellen MacKenzie, Ph.D.||Johns Hopkins University|