Effectiveness of a Peer Visitation Program to Improve Patient Activation and Quality of Life During Amputation Rehabilitation
AC PVP
1 other identifier
interventional
46
0 countries
N/A
Brief Summary
There is no known interventional clinical trial evidence for existing support and the reintegration strategy of a peer visitation program following amputation. The Amputee Coalition Peer Visitation Program is the only national and VA recognized program for amputees, however, it has not been rigorously tested for effectiveness. Therefore, the objective of this study is to demonstrate the Amputee Coalition Peer Visitation Program (AC PVP) will improve functional outcomes for Service Members, Veterans, and civilians during amputation rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedSeptember 28, 2020
September 1, 2020
5 months
October 23, 2017
September 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Function/Quality of Life - PVP Group
The MOS short-form health survey (SF-36) will be used to measure function. The SF-36 measures health status in eight dimensions: physical functioning; role limitations due to physical health problems; bodily pain; general health perceptions; vitality, energy, and fatigue; social functioning; role limitations due to emotional problems; and general mental health covering psychological distress and well-being. Scoring instructions from RAND Health provide guidance regarding scoring for each item in the survey and which items measure the aforementioned items.
60 days post-amputation
Function/Quality of Life -NoPVP group
The MOS short-form health survey (SF-36) will be used to measure function.The SF-36 measures health status in eight dimensions: physical functioning; role limitations due to physical health problems; bodily pain; general health perceptions; vitality, energy, and fatigue; social functioning; role limitations due to emotional problems; and general mental health covering psychological distress and well-being. Scoring instructions from RAND Health provide guidance regarding scoring for each item in the survey and which items measure the aforementioned items.
120 days post-amputation
Depression - PVP group
Depression is a treatable disorder associated commonly with amputation and can impact function and quality of life. The Patient Health Questionnaire (PHQ-9) is a questionnaire that can be entirely self-administered by the patient and interpreted by clinicians. The PHQ, a freely available instrument, assesses 8 diagnoses divided into threshold disorders and sub-threshold disorders
60 days post-amputation
Depression - NoPVP group
Depression is a treatable disorder associated commonly with amputation and can impact function and quality of life. The Patient Health Questionnaire (PHQ-9) is a questionnaire that can be entirely self-administered by the patient and interpreted by clinicians. The PHQ, a freely available instrument, assesses 8 diagnoses divided into threshold disorders and sub-threshold disorders
120 days post-amputation
Patient Activation - PVP Group
Patient activation will be measured using the Patient Activation Measure (PAM), which is an outcome measure with strong psychometric properties in chronic illness and is able to detect the level of patient activation towards their care management
60 days post-amputation
Patient Activation - NoPVP Group
Patient activation will be measured using the Patient Activation Measure (PAM), which is an outcome measure with strong psychometric properties in chronic illness and is able to detect the level of patient activation towards their care management
120 days post-amputation
Study Arms (2)
Peer Visitation Program (PVP)
EXPERIMENTALParticipants in this group will begin participation in the Peer Visitation Program (PVP) beginning at amputation date with the initiation window ranging from immediately pre-operative to 7 days post operative.
Delayed Peer Visitation (NoPVP)
NO INTERVENTIONNot participating in a Peer Visitation Program for 60 days post-operatively, followed by participation and completion in a PVP 60 days later than the PVP group for a total of 120 days.
Interventions
The Amputee Coalition's Peer Visitation Program (PVP) trains amputee peer supporters to properly navigate a new or less-experienced amputee through the process of rehabilitation. Peer support plays an important role, following the amputation of a limb, by allowing patients to meet other amputees and discuss lifestyle changes post-amputation. Subjects randomized to the PVP group will receive the intervention (visitation by a Certified Peer Visitor) immediately at amputation. Subjects randomized to the non-PVP group will not receive CPV visits immediately at amputation. Rather, they will receive delayed PVP intervention beginning 60 days after amputation and lasting a total of 60 days (or at 120 days post-amputation).
Eligibility Criteria
You may qualify if:
- Any candidate for lower extremity amputation
- Any immediate post operative lower extremity amputation within 7 days of amputation
- Willing and able to comply with the study protocol
- Able to provide informed consent
- Male or female, of any ethnicity
- years of age
- Any body weight
You may not qualify if:
- Any level of amputation other than lower extremity
- Known cognitive impairment
- Does not speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prosthetic Design & Researchlead
- Amputee Coalitioncollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2017
First Posted
October 31, 2017
Study Start
December 1, 2020
Primary Completion
April 15, 2021
Study Completion
August 1, 2021
Last Updated
September 28, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share