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Self-management to Improve Function Following Amputation
NA trial testing VETPALS in Amputation, Limb Loss in 182 participants. Completed in 21 March 2019.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 182 |
| Start date | 1 July 2014 |
| Primary completion | 21 March 2019 |
| Estimated completion | 21 March 2019 |
| Sites | 5 locations across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Amputation, Limb Loss. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Physical functioning will be measured using the Short Musculoskeletal Function Assessment (SMFA) Dysfunction Index. Range = 0 - 100 with higher values reflecting poorer physical function
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 32.34 | ± 17.85 |
| Individual Education Support Program | 30.19 | ± 19.42 |
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
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 5.14 | ± 4.83 |
| Individual Education Support Program | 5.87 | ± 6.23 |
Overall Quality of Life Scale. Range = 1-5 with higher values reflecting better quality of life.
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 3.86 | ± .88 |
| Individual Education Support Program | 3.77 | ± 1.13 |
Satisfaction with Health Scale. Range = 1 to 5. Higher values represented better satisfaction with health
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 3.69 | ± .96 |
| Individual Education Support Program | 3.32 | ± 1.38 |
Self-Efficacy for self-management of limb loss. Range = 0 to 10. Higher values reflect greater self-efficacy
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 7.96 | ± 1.78 |
| Individual Education Support Program | 7.89 | ± 2.15 |
Participant Active Engagement in Self-Care. Range = 1 to 5. Higher values reflect greater active engagement.
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 3.17 | ± .92 |
| Individual Education Support Program | 3.08 | ± .99 |
Active Problem Solving. Range = 0 to 100. Higher values represent greater problem solving
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 72.06 | ± 15.35 |
| Individual Education Support Program | 76.29 | ± 16.21 |
Positive Affect Subscale. Range = 10 to 50. Higher values represent greater positive affect.
| Group | Value | 95% CI |
|---|---|---|
| VETPALS | 32.69 | ± 9.94 |
| Individual Education Support Program | 31.38 | ± 10.04 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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