Improving Outcomes Following Limb Loss: PALS Plus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-08-31

Brief Summary

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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 disabilities. The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.

Detailed Description

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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. Study Design and Participants: The prospective clinical trial will use a two group, lagged-control design to evaluate the intervention at five health care facilities. 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. Improvements in primary and secondary outcomes will result through the impact on self efficacy, patient activation, catastrophizing and social support. 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 disabilities. The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.

Conditions

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Amputation

Keywords

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Amputation Self-management Rehabilitation Peer support

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Self-management and peer support

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults (aged 18-85 years) of both sexes and all races admitted to one of the seven participating acute care hospitals or rehabilitation facilities for an amputation procedure and/or treatment immediately following an amputation procedure, including traumatic amputations as well as amputations due to complications for diabetes mellitus, peripheral vascular disease, and malignancy.
* Women and minority patients will be represented in the trial according to the gender and race/ethnic prevalence of patients receiving treatment at the designated hospital and rehabilitation centers.

Exclusion Criteria

Criteria for exclusion from the study will include:

* Age less than 18 or over 85 years; and
* Inability to communicate in written or spoken English.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen T Wegener, PHD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Good Samaritan Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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CDC R01DD000153

Identifier Type: -

Identifier Source: org_study_id