An interventional study of Peer Visitation Program in Amputation, sponsored by Prosthetic Design & Research. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-28.
Sponsored by Prosthetic Design & Research · Not applicable, Interventional, and Supportive care
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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.
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.
409 studies on the registry are indexed under Patient Participation; 100 are open to participants now.
This study's planned enrollment of 46 is below the median of 128 across 322 interventional studies indexed under Patient Participation.
Browse Patient Participation studies →This is the only study on the registry with Prosthetic Design & Research as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Peer Visitation Program
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.
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).
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 120 days post-amputation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2020; primary completion for Apr 2021, 4 months later.
Of 226 interventional studies with no phase under Patient Participation, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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