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Self-management to Improve Function Following Amputation (VETPALS)

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ClinicalTrials.gov Identifier: NCT02163811
Recruitment Status : Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
Spectrum Research, Inc.
Johns Hopkins University
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Amputation, Limb Loss Behavioral: VETPALS Behavioral: Individual Education Support Program Not Applicable

Detailed Description:

Self-management interventions have been successful in improving outcomes across a broad variety of chronic illnesses including arthritis, asthma, diabetes, and hypertension. Initial evidence of the effectiveness of self-management following limb loss is promising, but limited. Only one published trial to date has examined self-management for amputees. The Promoting Amputee Life Skills (PALS) project, conducted by members of the current study team, designed and implemented an 8-week group-based intervention to improve self-management following limb loss. The current proposal builds upon previous research that has demonstrated the efficacy of the PALS self-management intervention, but addresses important next questions:

  1. Is the PALS self-management intervention appropriate for Veterans, specifically considering the very high prevalence of diabetes and vascular disease?
  2. Can it be housed and delivered within a health care system as opposed to existing community support groups?
  3. Will the intervention be more effective for individuals who are new amputees?
  4. Will a shorter format that also incorporates an option for video teleconferencing retain the efficacy of the original PALS intervention?

This study is a two-arm randomized controlled trial (RCT) to determine the efficacy of VETPALS. Study staff will screen and enroll Veterans with recent lower extremity limb loss within the last 6 months. Each participant will complete a baseline interview and then is sequentially placed into a cohort of 6-10 participants; each cohort will be randomized to the VETPALS group based self-management program (intervention) or an individual education support program (control). Once participants complete the randomized arm and follow-up assessments, they are free to participate in the other group. This ensures participants are offered both programs and are not deprived of a potentially valuable healthcare service.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-management to Improve Function Following Amputation
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: VETPALS
VETPALS is a five session course utilizing adult learning methods to teach self-management for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA Puget Sound clinician in conjunction with a peer facilitator (Veteran with limb loss).
Behavioral: VETPALS

VETPALS is an adaption of an empirically supported self-management program, PALS (Promoting Amputee Life Skills). The PALS program demonstrated improved physical and psychosocial functioning when delivered in community-based support groups for amputees, but this program has not been adapted for the needs of Veterans and implemented in the VA healthcare system.

VETPALS is a five session course for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA clinician in conjunction with a peer facilitator (Veteran with limb loss). Veterans receive all usual care.


Active Comparator: Individual Education Support Program
VETPALS facilitator provide post-amputation education materials from the Amputee Coalition, including First Step - A Guide for Adapting to Limb Loss and Side Step - A Guide to Preventing and Managing Diabetes and Its Complications. Veterans receive all usual care.
Behavioral: Individual Education Support Program
VETPALS facilitator provide post-amputation education materials from the Amputee Coalition, including First Step - A Guide for Adapting to Limb Loss and Side Step - A Guide to Preventing and Managing Diabetes and Its Complications. Veterans receive all usual care.




Primary Outcome Measures :
  1. Musculoskeletal Function Assessment Short Form (MFA-SF) [ Time Frame: 6 months ]
    Physical functioning will be measured using the Musculoskeletal Function Assessment Short Form (MFA-SF).

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ]
    Psychosocial functioning will be evaluated by examining depression using the Patient Health Questionnaire Depression Module (PHQ-9).


Secondary Outcome Measures :
  1. Modified Self-Efficacy Scale (MSES) [ Time Frame: 6-month ]
    Self-Efficacy for managing limb loss will be measured using the modified Self-Efficacy scale (MSES).

  2. Patient Activation Measure (PAM) [ Time Frame: 6 months ]
    Patient Activation will be measured by the Patient Activation Measure (PAM)

  3. Social Problem-Solving Inventory-Revised (SPSI-R) [ Time Frame: 6 months ]
    Problem Solving will be measured using the 10-item version of the Social Problem-Solving Inventory-Revised (SPSI-R).

  4. World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: 6 months ]
    Quality of Life will be measured using the brief form of the World Health Organization Quality of Life Scale (WHOQOL-BREF).

  5. Positive and Negative Affect Schedule (PANAS) [ Time Frame: 6 months ]
    Positive Affect will be measured using the Positive and Negative Affect Schedule (PANAS).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18 or older
  • Has had transmetatarsal amputation (through the foot including Chopart and Lisfranc amputation), transtibial amputation (below the knee), transfemoral amputation (above the knee), knee disarticulation (at knee), or hip disarticulation (at hip) due to dysvascular disease/diabetes. These can all include a revision of an amputation.
  • Participant has a contact address and phone number so that s/he can be reached during the course of the study.*
  • Enrolled within 6 months of amputation.
  • Speak and comprehend English.

    • The investigators will ask a participant who does not meet eligibility criteria because of inclusion criteria item 3 if s/he will have one in the near future, and if yes, permission to contact them again at that time. This allows the participant to be included, if interested and eligible, at a later date.

Exclusion Criteria:

  • Inadequate cognitive or language function to consent or participate defined by greater than or equal to 6 errors on the SPMSQ or diagnosis of dementia or Alzheimer's disease.
  • Active substance use disorder identified by chart review and initial screening. Note: No personnel involved in the study may identify, directly or indirectly, any individual patient or participant in any report of such research or otherwise disclose patient or participant identities in any manner.
  • Major uncontrolled psychiatric illness (bipolar disorder, psychosis, severe suicidality) identified by chart review and confirmed as necessary by discussion with current providers.
  • Spinal Cord Injury

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): NCT02163811


Locations
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Spectrum Research, Inc.
Johns Hopkins University
Investigators
Principal Investigator: Aaron P Turner, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
Principal Investigator: Gail Latlief, DO James A. Haley Veterans' Hospital, Tampa, FL
Principal Investigator: Samuel L. Phillips, PhD James A. Haley Veterans' Hospital, Tampa, FL

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02163811     History of Changes
Other Study ID Numbers: D1143-R
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Self-management
Functional status
Depression