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Improving Outcomes Following Limb Loss: PALS Plus (PALS-PLUS)

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ClinicalTrials.gov Identifier: NCT00447655
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 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.

Condition or disease Intervention/treatment Phase
Amputation Behavioral: Self-management and peer support Phase 1 Phase 2

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Outcomes Following Limb Loss: PALS Plus
Study Start Date : March 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Primary outcome measures are: pain, depressed mood, and positive mood.

Secondary Outcome Measures :
  1. Secondary outcome measures are: function, participation and bothersomeness of limitations

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00447655


Locations
United States, Maryland
Good Samaritan Hospital
Baltimore, Maryland, United States, 21239
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Stephen T Wegener, PHD Johns Hopkins University
More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00447655     History of Changes
Other Study ID Numbers: CDC R01DD000153
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
Amputation
Self-management
Rehabilitation
Peer support