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Self-management to Improve Function Following Amputation (VETPALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163811
Recruitment Status : Completed
First Posted : June 16, 2014
Results First Posted : August 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Spectrum Research, Inc.
Johns Hopkins University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Amputation, Limb Loss
Interventions Behavioral: VETPALS
Behavioral: Individual Education Support Program
Enrollment 182
Recruitment Details Of 182 enrolled 147 were randomized
Pre-assignment Details 9 Deaths, 26 withdrawal
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description 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: 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.
Period Title: Overall Study
Started 71 76
Completed 35 60
Not Completed 36 16
Arm/Group Title VETPALS Individual Education Support Program Total
Hide Arm/Group Description 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: 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. Total of all reporting groups
Overall Number of Baseline Participants 71 76 147
Hide Baseline Analysis Population Description
Individuals with Limb Loss Randomized to VETPALS or Education Control
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 76 participants 147 participants
64.89  (8.34) 64.12  (8.55) 64.49  (8.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 76 participants 147 participants
Female
3
   4.2%
0
   0.0%
3
   2.0%
Male
68
  95.8%
76
 100.0%
144
  98.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 76 participants 147 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
1
   0.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   2.6%
2
   1.4%
Black or African American
25
  35.2%
18
  23.7%
43
  29.3%
White
44
  62.0%
50
  65.8%
94
  63.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.8%
5
   6.6%
7
   4.8%
Marital Status (Married)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 76 participants 147 participants
32
  45.1%
26
  34.2%
58
  39.5%
Education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 76 participants 147 participants
13.44  (2.2) 13.96  (2.26) 13.71  (2.24)
Months since amputation  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 71 participants 76 participants 147 participants
10.49  (7.32) 9.62  (5.54) 10.04  (6.45)
Amputation Level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 76 participants 147 participants
Transmetatarsal
3
   4.2%
8
  10.5%
11
   7.5%
Transtibial
53
  74.6%
57
  75.0%
110
  74.8%
Transfemoral
15
  21.1%
11
  14.5%
26
  17.7%
Comorbidity  
Mean (Standard Deviation)
Unit of measure:  Comorbidities
Number Analyzed 71 participants 76 participants 147 participants
4.90  (2.71) 4.11  (2.36) 4.49  (2.55)
Mental Status   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
9.73  (.54) 9.62  (.71) 9.67  (.63)
[1]
Measure Description: Short Portable Mental Status Questionnaire, range 0-10, higher scores indicating better function
Physical Functioning   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
33.17  (16.19) 29.14  (15.35) 31.09  (15.84)
[1]
Measure Description: Short Musculoskeletal Functional Assessment dysfunction index, range = 0-100 with higher scores indicating poorer function.
Psychosocial Functioning   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
6.08  (5.75) 4.22  (4.37) 5.12  (5.15)
[1]
Measure Description: Patient Health Questionnaire depression module (PHQ-9). Scores range from 0 to 27 with higher scores indicating higher levels of depression
Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
47.75  (25.48) 41.75  (27.13) 44.65  (26.43)
[1]
Measure Description: Chronic Pain Grade Pain Intensity. Range = 0-100 with higher values reflecting higher levels of pain intensity
Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
3.69  (.98) 3.87  (.90) 3.78  (.94)
[1]
Measure Description: World Health Organization Quality of Life Scale (WHOQoL-BREF): Overall quality of life. Range = 1-5 with higher scores indicating higher QoL
Satisfaction with Health   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
3.30  (.98) 3.64  (1.09) 3.48  (1.05)
[1]
Measure Description: World Health Organization Quality of Life Scale (WHOQoL-BREF): Satisfaction with Health. Range = 1-5 with higher scores indicating higher satisfaction with health.
Social Support (MSPSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
5.25  (1.38) 5.39  (1.47) 5.33  (1.42)
[1]
Measure Description: Multidimensional Scale of Perceived Social Support. Range = 1-7 with higher values indicating higher levels of social support
Self-Efficacy   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
7.72  (2.12) 8.14  (1.71) 7.94  (1.93)
[1]
Measure Description: Measure of self-efficacy. Range = 0-10 with higher levels indicating higher levels of self-efficacy
Patient Activation Measure   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
3.01  (.73) 3.21  (.75) 3.12  (.75)
[1]
Measure Description: Measure of patient engagement and activation in health and self care. Range = 1-5 with higher values representing greater patient activation.
Social Problem Solving Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
72.56  (15.83) 77.27  (14.20) 74.99  (15.14)
[1]
Measure Description: Measure of problem solving. Range 0-100 with higher scores representing better problem solving
Positive and Negative Affect Scale (PANAS) Positive Affect Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 71 participants 76 participants 147 participants
31.83  (9.15) 33.57  (9.84) 32.73  (9.52)
[1]
Measure Description: Positive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect
1.Primary Outcome
Title Short Musculoskeletal Function Assessment (SMFA)
Hide Description Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
32.34  (17.85) 30.19  (19.42)
2.Primary Outcome
Title Patient Health Questionnaire (PHQ-9)
Hide Description 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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.14  (4.83) 5.87  (6.23)
3.Secondary Outcome
Title World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life
Hide Description Overall Quality of Life Scale. Range = 1-5 with higher values reflecting better quality of life.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.86  (.88) 3.77  (1.13)
4.Secondary Outcome
Title World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health
Hide Description Satisfaction with Health Scale. Range = 1 to 5. Higher values represented better satisfaction with health
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.69  (.96) 3.32  (1.38)
5.Other Pre-specified Outcome
Title Self-Efficacy
Hide Description Self-Efficacy for self-management of limb loss. Range = 0 to 10. Higher values reflect greater self-efficacy
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.96  (1.78) 7.89  (2.15)
6.Other Pre-specified Outcome
Title Patient Activation Measure
Hide Description Participant Active Engagement in Self-Care. Range = 1 to 5. Higher values reflect greater active engagement.
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.17  (.92) 3.08  (.99)
7.Other Pre-specified Outcome
Title Social Problem Solving Inventory
Hide Description Active Problem Solving. Range = 0 to 100. Higher values represent greater problem solving
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
72.06  (15.35) 76.29  (16.21)
8.Other Pre-specified Outcome
Title Positive and Negative Affect Scale (PANAS) Positive Affect Score
Hide Description Positive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect.
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 35 60
Mean (Standard Deviation)
Unit of Measure: score on a scale
32.69  (9.94) 31.38  (10.04)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VETPALS Individual Education Support Program
Hide Arm/Group Description 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: 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.
All-Cause Mortality
VETPALS Individual Education Support Program
Affected / at Risk (%) Affected / at Risk (%)
Total   6/71 (8.45%)   2/76 (2.63%) 
Hide Serious Adverse Events
VETPALS Individual Education Support Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/76 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VETPALS Individual Education Support Program
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/76 (0.00%) 
Results based on a sample of individuals with dysvascular disease/diabetes and may not generalize to all amputees.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Aaron Turner
Organization: VA Puget Sound Health Care System
Phone: (206) 277-6134
EMail: Aaron.Turner@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02163811    
Other Study ID Numbers: D1143-R
First Submitted: June 5, 2014
First Posted: June 16, 2014
Results First Submitted: July 1, 2020
Results First Posted: August 5, 2020
Last Update Posted: August 5, 2020