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Improving Outcomes Following Limb Loss: PALS Plus

Phase 1/Phase 2
18 Years
85 Years
Not Enrolling

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Trial Information

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 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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Stephen T Wegener, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Institutional Review Board

Study ID:

CDC R01DD000153



Start Date:

March 2007

Completion Date:

August 2009

Related Keywords:

  • Amputation
  • Amputation
  • Self-management
  • Rehabilitation
  • Peer support



Good Samaritan HospitalBaltimore, Maryland  21239