Clinical trial NCT03326115: Effectiveness of a Peer Visitation Program to Improve Patient Activation and Quality of Life During Amputation Rehabilitation
Official title: Effectiveness of a Peer Visitation Program to Improve Patient Activation and Functional Outcomes and Quality of Life During Amputation Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Keywords: patient activation
peer visitation
amputee
Lead sponsor: Prosthetic Design & Research
Sponsor class: INDUSTRY
Collaborators: name: Amputee Coalition
First posted: 2017-10-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Any level of amputation other than lower extremity
* Known cognitive impairment
* Does not speak English

Primary outcomes:
measure: Function/Quality of Life - PVP Group
timeFrame: 60 days post-amputation
measure: Function/Quality of Life -NoPVP group
timeFrame: 120 days post-amputation
measure: Depression - PVP group
timeFrame: 60 days post-amputation
measure: Depression - NoPVP group
timeFrame: 120 days post-amputation
measure: Patient Activation - PVP Group
timeFrame: 60 days post-amputation
measure: Patient Activation - NoPVP Group
timeFrame: 120 days post-amputation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: