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NCT00447655 · ClinicalTrials.gov registry record · Phase 1
Improving Outcomes Following Limb Loss: PALS Plus
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 400
- Enrollment target
NCT00447655: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT00447655 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 400 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00447655, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 400 participants
- Enrollment target
Study Summary
Limb loss can result from a variety of etiologies including diabetes, trauma and cancer. Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life. Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss. Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training. Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss. A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group. Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group. Assessment will be at baseline, treatment completion and six month follow-up. Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood. Secondary outcome measures are: function, participation and bothersomeness of limitations. The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss. Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabil
Interventions
- BEHAVIORAL Self-management and peer support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00447655
The ClinicalTrials.gov registry entry for NCT00447655 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Self-management and peer support is the first listed.
NCT00447655 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00447655 about?
NCT00447655 is a clinical study titled "Improving Outcomes Following Limb Loss: PALS Plus". Limb loss can result from a variety of etiologies including diabetes, trauma and cancer. Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life. Intervention: Working with the Amputee Coaliti...
What is the current status of trial NCT00447655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 400 participants. The study started on 2007-03. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00447655?
The interventions under investigation include: Self-management and peer support (BEHAVIORAL).
Who is sponsoring clinical trial NCT00447655?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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