Trial Outcomes & Findings for Self-management to Improve Function Following Amputation (NCT NCT02163811)
NCT ID: NCT02163811
Last Updated: 2020-08-05
Results Overview
Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
6 months
Results posted on
2020-08-05
Participant Flow
Of 182 enrolled 147 were randomized
9 Deaths, 26 withdrawal
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
76
|
|
Overall Study
COMPLETED
|
35
|
60
|
|
Overall Study
NOT COMPLETED
|
36
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-management to Improve Function Following Amputation
Baseline characteristics by cohort
| Measure |
VETPALS
n=71 Participants
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
n=76 Participants
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
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.89 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
64.12 years
STANDARD_DEVIATION 8.55 • n=7 Participants
|
64.49 years
STANDARD_DEVIATION 8.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital Status (Married)
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Education
|
13.44 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
13.96 years
STANDARD_DEVIATION 2.26 • n=7 Participants
|
13.71 years
STANDARD_DEVIATION 2.24 • n=5 Participants
|
|
Months since amputation
|
10.49 Months
STANDARD_DEVIATION 7.32 • n=5 Participants
|
9.62 Months
STANDARD_DEVIATION 5.54 • n=7 Participants
|
10.04 Months
STANDARD_DEVIATION 6.45 • n=5 Participants
|
|
Amputation Level
Transmetatarsal
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Amputation Level
Transtibial
|
53 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Amputation Level
Transfemoral
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Comorbidity
|
4.90 comorbidities
STANDARD_DEVIATION 2.71 • n=5 Participants
|
4.11 comorbidities
STANDARD_DEVIATION 2.36 • n=7 Participants
|
4.49 comorbidities
STANDARD_DEVIATION 2.55 • n=5 Participants
|
|
Mental Status
|
9.73 units on a scale
STANDARD_DEVIATION .54 • n=5 Participants
|
9.62 units on a scale
STANDARD_DEVIATION .71 • n=7 Participants
|
9.67 units on a scale
STANDARD_DEVIATION .63 • n=5 Participants
|
|
Physical Functioning
|
33.17 units on a scale
STANDARD_DEVIATION 16.19 • n=5 Participants
|
29.14 units on a scale
STANDARD_DEVIATION 15.35 • n=7 Participants
|
31.09 units on a scale
STANDARD_DEVIATION 15.84 • n=5 Participants
|
|
Psychosocial Functioning
|
6.08 units on a scale
STANDARD_DEVIATION 5.75 • n=5 Participants
|
4.22 units on a scale
STANDARD_DEVIATION 4.37 • n=7 Participants
|
5.12 units on a scale
STANDARD_DEVIATION 5.15 • n=5 Participants
|
|
Pain
|
47.75 units on a scale
STANDARD_DEVIATION 25.48 • n=5 Participants
|
41.75 units on a scale
STANDARD_DEVIATION 27.13 • n=7 Participants
|
44.65 units on a scale
STANDARD_DEVIATION 26.43 • n=5 Participants
|
|
Quality of Life
|
3.69 units on a scale
STANDARD_DEVIATION .98 • n=5 Participants
|
3.87 units on a scale
STANDARD_DEVIATION .90 • n=7 Participants
|
3.78 units on a scale
STANDARD_DEVIATION .94 • n=5 Participants
|
|
Satisfaction with Health
|
3.30 units on a scale
STANDARD_DEVIATION .98 • n=5 Participants
|
3.64 units on a scale
STANDARD_DEVIATION 1.09 • n=7 Participants
|
3.48 units on a scale
STANDARD_DEVIATION 1.05 • n=5 Participants
|
|
Social Support (MSPSS)
|
5.25 units on a scale
STANDARD_DEVIATION 1.38 • n=5 Participants
|
5.39 units on a scale
STANDARD_DEVIATION 1.47 • n=7 Participants
|
5.33 units on a scale
STANDARD_DEVIATION 1.42 • n=5 Participants
|
|
Self-Efficacy
|
7.72 units on a scale
STANDARD_DEVIATION 2.12 • n=5 Participants
|
8.14 units on a scale
STANDARD_DEVIATION 1.71 • n=7 Participants
|
7.94 units on a scale
STANDARD_DEVIATION 1.93 • n=5 Participants
|
|
Patient Activation Measure
|
3.01 units on a scale
STANDARD_DEVIATION .73 • n=5 Participants
|
3.21 units on a scale
STANDARD_DEVIATION .75 • n=7 Participants
|
3.12 units on a scale
STANDARD_DEVIATION .75 • n=5 Participants
|
|
Social Problem Solving Inventory
|
72.56 units on a scale
STANDARD_DEVIATION 15.83 • n=5 Participants
|
77.27 units on a scale
STANDARD_DEVIATION 14.20 • n=7 Participants
|
74.99 units on a scale
STANDARD_DEVIATION 15.14 • n=5 Participants
|
|
Positive and Negative Affect Scale (PANAS) Positive Affect Score
|
31.83 units on a scale
STANDARD_DEVIATION 9.15 • n=5 Participants
|
33.57 units on a scale
STANDARD_DEVIATION 9.84 • n=7 Participants
|
32.73 units on a scale
STANDARD_DEVIATION 9.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPhysical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Short Musculoskeletal Function Assessment (SMFA)
|
32.34 score on a scale
Standard Deviation 17.85
|
30.19 score on a scale
Standard Deviation 19.42
|
PRIMARY outcome
Timeframe: 6 monthsPsychosocial 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
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
|
5.14 score on a scale
Standard Deviation 4.83
|
5.87 score on a scale
Standard Deviation 6.23
|
SECONDARY outcome
Timeframe: 6 monthsOverall Quality of Life Scale. Range = 1-5 with higher values reflecting better quality of life.
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
World Health Organization Quality of Life Scale (WHOQOL-BREF) Overall Quality of Life
|
3.86 score on a scale
Standard Deviation .88
|
3.77 score on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 6 monthsSatisfaction with Health Scale. Range = 1 to 5. Higher values represented better satisfaction with health
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
World Health Organization Quality of Life Scale (WHOQOL-BREF) Satisfaction With Health
|
3.69 score on a scale
Standard Deviation .96
|
3.32 score on a scale
Standard Deviation 1.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthSelf-Efficacy for self-management of limb loss. Range = 0 to 10. Higher values reflect greater self-efficacy
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Self-Efficacy
|
7.96 score on a scale
Standard Deviation 1.78
|
7.89 score on a scale
Standard Deviation 2.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthParticipant Active Engagement in Self-Care. Range = 1 to 5. Higher values reflect greater active engagement.
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Patient Activation Measure
|
3.17 score on a scale
Standard Deviation .92
|
3.08 score on a scale
Standard Deviation .99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthActive Problem Solving. Range = 0 to 100. Higher values represent greater problem solving
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Social Problem Solving Inventory
|
72.06 score on a scale
Standard Deviation 15.35
|
76.29 score on a scale
Standard Deviation 16.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthPositive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect.
Outcome measures
| Measure |
VETPALS
n=35 Participants
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
n=60 Participants
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.
|
|---|---|---|
|
Positive and Negative Affect Scale (PANAS) Positive Affect Score
|
32.69 score on a scale
Standard Deviation 9.94
|
31.38 score on a scale
Standard Deviation 10.04
|
Adverse Events
VETPALS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Individual Education Support Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place