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| Name | Class |
|---|---|
| Spectrum Research, Inc. | INDUSTRY |
| Johns Hopkins University | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VETPALS | Experimental | 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). |
|
| Individual Education Support Program | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VETPALS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Musculoskeletal Function Assessment (SMFA) | Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function | 6 months |
| Patient Health Questionnaire (PHQ-9) | Psychosocial functioning will be evaluated by examining depression using the Patient Health Questionnaire Depression Module (PHQ-9). Range = 0-27 with higher scores indicating greater levels of depression | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life | Overall Quality of Life Scale. Range = 1-5 with higher values reflecting better quality of life. | 6 months |
| World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy | Self-Efficacy for self-management of limb loss. Range = 0 to 10. Higher values reflect greater self-efficacy | 6 month |
| Patient Activation Measure | Participant Active Engagement in Self-Care. Range = 1 to 5. Higher values reflect greater active engagement. |
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States | ||
| Minneapolis VA Health Care System, Minneapolis, MN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811854 | Derived | Turner AP, Wegener ST, Williams RM, Ehde DM, Norvell DC, Yanez ND, Czerniecki JM, Study Group V. Self-Management to Improve Function After Amputation: A Randomized Controlled Trial of the VETPALS Intervention. Arch Phys Med Rehabil. 2021 Jul;102(7):1274-1282. doi: 10.1016/j.apmr.2021.02.027. Epub 2021 Apr 1. |
| Label | URL |
|---|---|
| Click here for more information about this study: Self-management to Improve Function Following Amputation | View source |
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9 Deaths, 26 withdrawal
Of 182 enrolled 147 were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Individual Education Support Program | Individual Education Support Program: VETPALS facilitator provides post-amputation education materials from the Amputee Coalition and offer for individual follow-up for explanation if requested. Veterans receive all usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Individuals with Limb Loss Randomized to VETPALS or Education Control
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short Musculoskeletal Function Assessment (SMFA) | Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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Results based on a sample of individuals with dysvascular disease/diabetes and may not generalize to all amputees.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron Turner | VA Puget Sound Health Care System | (206) 277-6134 | Aaron.Turner@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2017 | Jul 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Individual Education Support Program | Behavioral | 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. |
|
Satisfaction with Health Scale. Range = 1 to 5. Higher values represented better satisfaction with health |
| 6 months |
| 6 month |
| Social Problem Solving Inventory | Active Problem Solving. Range = 0 to 100. Higher values represent greater problem solving | 6 month |
| Positive and Negative Affect Scale (PANAS) Positive Affect Score | Positive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect. | 6 month |
| Minneapolis |
| Minnesota |
| 55417 |
| United States |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | United States |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| Individual Education Support Program |
Individual Education Support Program: VETPALS facilitator provides post-amputation education materials from the Amputee Coalition and offer for individual follow-up for explanation if requested. Veterans receive all usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status (Married) | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Months since amputation | Mean | Standard Deviation | Months |
|
| Amputation Level | Count of Participants | Participants |
|
| Comorbidity | Mean | Standard Deviation | comorbidities |
|
| Mental Status | Short Portable Mental Status Questionnaire, range 0-10, higher scores indicating better function | Mean | Standard Deviation | units on a scale |
|
| Physical Functioning | Short Musculoskeletal Functional Assessment dysfunction index, range = 0-100 with higher scores indicating poorer function. | Mean | Standard Deviation | units on a scale |
|
| Psychosocial Functioning | Patient Health Questionnaire depression module (PHQ-9). Scores range from 0 to 27 with higher scores indicating higher levels of depression | Mean | Standard Deviation | units on a scale |
|
| Pain | Chronic Pain Grade Pain Intensity. Range = 0-100 with higher values reflecting higher levels of pain intensity | Mean | Standard Deviation | units on a scale |
|
| Quality of Life | World Health Organization Quality of Life Scale (WHOQoL-BREF): Overall quality of life. Range = 1-5 with higher scores indicating higher QoL | Mean | Standard Deviation | units on a scale |
|
| Satisfaction with Health | World Health Organization Quality of Life Scale (WHOQoL-BREF): Satisfaction with Health. Range = 1-5 with higher scores indicating higher satisfaction with health. | Mean | Standard Deviation | units on a scale |
|
| Social Support (MSPSS) | Multidimensional Scale of Perceived Social Support. Range = 1-7 with higher values indicating higher levels of social support | Mean | Standard Deviation | units on a scale |
|
| Self-Efficacy | Measure of self-efficacy. Range = 0-10 with higher levels indicating higher levels of self-efficacy | Mean | Standard Deviation | units on a scale |
|
| Patient Activation Measure | Measure of patient engagement and activation in health and self care. Range = 1-5 with higher values representing greater patient activation. | Mean | Standard Deviation | units on a scale |
|
| Social Problem Solving Inventory | Measure of problem solving. Range 0-100 with higher scores representing better problem solving | Mean | Standard Deviation | units on a scale |
|
| Positive and Negative Affect Scale (PANAS) Positive Affect Score | Positive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Patient Health Questionnaire (PHQ-9) | Psychosocial functioning will be evaluated by examining depression using the Patient Health Questionnaire Depression Module (PHQ-9). Range = 0-27 with higher scores indicating greater levels of depression | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life | Overall Quality of Life Scale. Range = 1-5 with higher values reflecting better quality of life. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health | Satisfaction with Health Scale. Range = 1 to 5. Higher values represented better satisfaction with health | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Other Pre-specified | Self-Efficacy | Self-Efficacy for self-management of limb loss. Range = 0 to 10. Higher values reflect greater self-efficacy | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
| Other Pre-specified | Patient Activation Measure | Participant Active Engagement in Self-Care. Range = 1 to 5. Higher values reflect greater active engagement. | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
| Other Pre-specified | Social Problem Solving Inventory | Active Problem Solving. Range = 0 to 100. Higher values represent greater problem solving | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
| Other Pre-specified | Positive and Negative Affect Scale (PANAS) Positive Affect Score | Positive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect. | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
| 6 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Individual Education Support Program | Individual Education Support Program: VETPALS facilitator provides post-amputation education materials from the Amputee Coalition and offer for individual follow-up for explanation if requested. Veterans receive all usual care. | 2 | 76 | 0 | 76 | 0 | 76 |
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