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Self-management to Improve Function Following Amputation
NCT02163811 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02163811
The ClinicalTrials.gov registry entry for NCT02163811 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02163811 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Florida, Minnesota, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02163811?
The interventions under investigation include: VETPALS (BEHAVIORAL), Individual Education Support Program (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02163811?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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