AmputationAC PVPNCT03326115
Effectiveness of a Peer Visitation Program to Improve Patient Activation and Quality of Life During Amputation Rehabilitation
A study testing Peer Visitation Program in people with Amputation, run by Prosthetic Design & Research.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amputation
- What is being tested?
- Peer Visitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 18 - 75 years of age
- Any body weight
Who cannot join
- Any level of amputation other than lower extremity
- Known cognitive impairment
- Does not speak English
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of a Peer Visitation Program to Improve Patient Activation and Functional Outcomes and Quality of Life During Amputation Rehabilitation
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.
Read the detailed description
In the fields of medicine and public health management, navigation and peer visitation programs consider patients as are their own important resources, who should be actively involved in the health care organization and throughout the process of care delivery and rehabilitation. The importance of promoting a more active role of patients in the management of their own health care is recognized by health care experts, managers, and policy makers. Programs that engage patients in their own health care are reported as an important strategy to improve adherence, outcomes, satisfaction toward the health care provider, and reduction of health care costs. The emotional adjustment to an amputation is sometimes the most challenging part. Peer visitation allows the patient to speak directly with another amputee who has shared a similar experience, allowing them to relate feelings and concerns about the loss of a limb to someone who has already endured the process and lives with the condition daily.
There is increasing national and international interest in patient education programs. The ultimate anticipated outcome for individuals attending these programs is improvement in quality of life. Patient empowerment, self-efficacy, and self-management have also been found to be key intermediate outcomes of acute amputation rehabilitation, but have been somewhat difficult to operationalize, measure, and subsequently report in terms of patient impact. 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.
- Conditions
- Amputation
- Being tested
- Peer Visitation Program
- Keywords
- patient activation, peer visitation, amputee
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Visitation ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Peer Visitation Program (PVP) | Experimental | Participants 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. Receives: Behavioral: Peer Visitation Program |
| Delayed Peer Visitation (NoPVP) | No intervention | Not 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 120 days post-amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Dec 2020 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prosthetic Design & Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amputee Coalition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326115
- Sponsor's protocol ID
- AC PVP
- Acronym
- AC PVP
- Status last verified
- Sep 2020
- First submitted
- 23 Oct 2017
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Peer Visitation Program to Improve Patient Activation and Functional Outcomes and Quality of Life During Amputation Rehabilitation
- ClinicalTrials.gov ID
- NCT03326115
- Acronym / sponsor ID
- AC PVP / AC PVP
- Conditions
- Amputation
- Keywords
- patient activation, peer visitation, amputee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Prosthetic Design & ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Amputee Coalition
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the fields of medicine and public health management, navigation and peer visitation programs consider patients as are their own important resources, who should be actively involved in the health care organization and throughout the process of care delivery and rehabilitation. The importance of promoting a more active role of patients in the management of their own health care is recognized by health care experts, managers, and policy makers. Programs that engage patients in their own health care are reported as an important strategy to improve adherence, outcomes, satisfaction toward the health care provider, and reduction of health care costs. The emotional adjustment to an amputation is sometimes the most challenging part. Peer visitation allows the patient to speak directly with another amputee who has shared a similar experience, allowing them to relate feelings and concerns about the loss of a limb to someone who has already endured the process and lives with the condition daily.
There is increasing national and international interest in patient education programs. The ultimate anticipated outcome for individuals attending these programs is improvement in quality of life. Patient empowerment, self-efficacy, and self-management have also been found to be key intermediate outcomes of acute amputation rehabilitation, but have been somewhat difficult to operationalize, measure, and subsequently report in terms of patient impact. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Visitation Program (PVP) | Experimental | Behavioral: Peer Visitation ProgramParticipants 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 intervention | –Not 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Any level of amputation other than lower extremity
- Known cognitive impairment
- Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Visitation ProgramThe 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). | Behavioural | Peer Visitation Program (PVP) |
Primary outcome
Function/Quality of Life - PVP Group
Time frame: 60 days post-amputation
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.
Function/Quality of Life -NoPVP group
Time frame: 120 days post-amputation
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.
Depression - PVP group
Time frame: 60 days post-amputation
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
Depression - NoPVP group
Time frame: 120 days post-amputation
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
Patient Activation - PVP Group
Time frame: 60 days post-amputation
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
Patient Activation - NoPVP Group
Time frame: 120 days post-amputation
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Visitation Program in people with Amputation, run by Prosthetic Design & Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Kahle, M.S.M.S. (813-971-1100, jason@prostheticdr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function/Quality of Life - PVP Group (time frame: 60 days post-amputation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.