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NCT02163811 · ClinicalTrials.gov registry record · NA
Self-management to Improve Function Following Amputation
A NA study of Amputation, Limb Loss, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 182
- Enrollment target
- 5
- Study locations
NCT02163811: Completed NA study of Amputation, Limb Loss, sponsored by VA Office of Research and Development.
NCT02163811 is a NA study of Amputation, Limb Loss that has completed, run by VA Office of Research and Development. The registered enrollment target is 182 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02163811, a NA study of Amputation, Limb Loss, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
- 5
- Study locations
Study Summary
Lower extremity amputations are a significant cause of morbidity, mortality, loss of function and reduced quality of life. Self-management (defined as the process by which an individual adopts an active role in managing the symptoms, treatment, consequences, and lifestyle changes inherent in living with a chronic condition) is an important mechanism for improving health and reducing disability. This study will evaluate a 5-week group-based self-management intervention for Veterans with lower extremity limb loss (VETPALS) and determine its impact upon physical and psychosocial functioning, patient activation, self-efficacy, problem solving, quality of life and positive affect. This study represents one of the only prospective randomized controlled trials of a behavioral intervention for individuals with limb loss. It is expected that results will be used to inform the integration of self-management interventions into the VA Amputation System of Care. The specific primary hypotheses are: 1. Individuals randomized to VETPALS will display greater improvements from baseline in physical functioning as measured by the MFA-SF than Veterans in the individual education support condition post-intervention and at a 6 month follow-up. 2. Individuals randomized to VETPALS will display greater improvements from baseline in psychosocial functioning as measured by the PHQ-9 than Veterans in the individual education support condition post-intervention and at a 6 month follow-up.
Primary Outcome
Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function
Conditions Studied
Interventions
- BEHAVIORAL VETPALS
- BEHAVIORAL Individual Education Support Program
Study Locations (5)
Florida
- James A. Haley Veterans' Hospital, Tampa, FL - Tampa
Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis
Ohio
- Louis Stokes VA Medical Center, Cleveland, OH - Cleveland
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2014-07-01 |
| Est. Completion | 2019-03-21 |
| Phase | NA |
What the finished NCT02163811 record still lists
NCT02163811 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Amputation, Limb Loss appearing as the primary indexed condition, and to 2 interventions - of which VETPALS is the first listed.
NCT02163811 lists 5 locations in 5 states (Florida, Minnesota, Ohio).
Frequently Asked Questions
What is clinical trial NCT02163811 about?
NCT02163811 is a clinical study titled "Self-management to Improve Function Following Amputation". Lower extremity amputations are a significant cause of morbidity, mortality, loss of function and reduced quality of life. Self-management (defined as the process by which an individual adopts an active role in managing the symptoms, treatment, consequences, and lifestyle changes inherent in living ...
What is the current status of trial NCT02163811?
This trial is currently completed. It is a NA study. The enrollment target is 182 participants. The study started on 2014-07-01. Estimated completion is 2019-03-21.
What conditions does trial NCT02163811 study?
This clinical trial studies the following conditions: Amputation, Limb Loss.
What interventions are being tested in trial NCT02163811?
The interventions under investigation include: VETPALS (BEHAVIORAL), Individual Education Support Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT02163811?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02163811 being conducted?
This trial has 5 study locations across Florida, Minnesota, Ohio, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02163811's enrollment target sits among peer trials
182 584th of 2000 higher than 1,415 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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