Self-management to Improve Function Following Amputation
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/1/2018 |
| Start Date: | July 1, 2014 |
| End Date: | June 30, 2019 |
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.
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.
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.
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.
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
We found this trial at
5
sites
Seattle, Washington 98108
Principal Investigator: Aaron P Turner, PhD
Phone: 206-764-2991
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