Clinical and Translational Research Infrastructure Network (MW-CTR-IN) Year 10: Examining Socioeconomic Disparities in Functional Outcomes of People with Lower Limb Amputation # a Multi-Site Collaborative Study

Statement of Work for Dr. Sheila Clemens (Site PI) University of Kentucky Project Title: Examining socioeconomic disparities in functional outcomes of people with lower limb amputation – a multi-site collaborative study Period of Performance: 7/1/2023 - 6/30/2024 Objective: The purpose of the proposed research project is to examine the presence and influence of health inequity and disparity within the limb loss population in our multi-site prosthetic clinical research network. Dr. Clemens’s role in this study is to serve as a site lead investigator at the Kentucky/Ohio study sites at the University of Kentucky. Dr. Clemens will be responsible for recruiting and collecting data on 1/5 of the cohort of participants (n=20) over the duration of the study. Dr. Clemens maintains relationships with various prosthetic clinics, hospitals, and amputee support groups in the Kentucky and Ohio regions, enhancing her ability to recruit participants for the study. Anticipated workload requirements will include time and effort to be 2-4 hours per week with potential fluctuation depending on coordination of the availability of the participants and other responsibilities. Background: There are over 1 million people living with major lower limb amputation (LLA) in the U.S. Minorities exhibit a higher prevalence of LLA in the U.S. (1 in 90 non-whites compared to 1 in 250 whites), a rate up to four times greater than non-Hispanic whites. This disparity is likely fueled by the increased rate of peripheral vascular disease and diabetes in minorities. Amputations may be the impetus for a detrimental spiral into socioeconomic difficulty and poorer quality of life. This research will help determine what socioenvironmental factors affect mobility after amputation and will provide us information on how to identify risk factors for mobility deficits after amputation. Results from this study will provide information to guide future research, and the development of rehabilitative and prosthetic interventions to improve walking and mobility function in people with lower limb amputation. Personnel Requirements: Sheila Clemens, PhD, PT, Site Principal Investigator: Dr. Clemens is a tenure-track Assistant Professor at the Department of Physical Therapy, University of Kentucky. Dr. Clemens has experience with supervising human research studies including data collection of patients with amputation. Tasks/Scientific Goals: Specific Aim 1 Examine the effects of socioeconomic disparities on functional Timeline Deliverable outcomes in individuals with LLA. (months) Major Task 1: Participant recruitment from affiliated prosthetic Months Obtaining commitment and letters of clinics and patient support groups 0-10 authorization from participating data 0-6 collection sites in Kentucky and Ohio Subtask 1: Obtain letters of authorization from the affiliated data agreeing to the provision of physical collection sites to enable recruitment and data collection space for data collection and participant recruitment 1 Subtask 2: Coordinate scheduling protocol with clinical data 0-6 Establish agreed upon protocol specific collection sites to each participating site for scheduling of study participants Milestone(s) achieved: IRB approval of all data collection sites; 6 scheduling protocol established with sites 0-2 Receiving funds for essential study 0-2 equipment/supplies. Major Task 2: Purchasing of equipment/supplies to enable data Establishing a participant payment collection mechanism Subtask 3: Purchase of essential study equipment/supplies Contact a minimum of 30 individuals designated as potential study Subtask 4: Arranging of participant payments per UK 0-2 participants regulations 2 Successful consenting and enrolling 20 participants to the study Milestone(s) achieved: Granting of subaward funds to UK; 2-12 purchase of study supplies/equipment; securing of 2-12 Attend virtual meetings to discuss data participant payment agreement collection protocol. Participation in scheduled mock data collection training Major Task 3: Recruitment, consenting and enrollment of 20 Collect data from intake forms and self- individuals with lower limb amputation reported health, socioenvironmental factor and mobility questionnaires for Subtask 5: Identification of potential study participants 20 participants Complete timed scores and distance Subtask 6: Screen at least 30 potential participants, enrollment of 3-12 measured data for 20 participants 20 participants Complete and organize data collection Milestone(s) achieved: recruitment, screening, consenting and 12 results from all participants enrollment of study participants Attend meeting(s) with key study personnel to discuss study results Major Task 4: Data collection to examine prosthetic mobility Months and the effect of socioenvironmental factors in individuals of 0-12 black/Hispanic race/ethnicity and non-Hispanic whites from varying income levels. Subtask 7: Training of research personnel on administration of 0-6 study protocol to include intake forms, self-report questionnaires and performance-based outcome measures Subtask 8: Administration of intake forms, amputation related 2-12 questionnaires, rehabilitation related questionnaires and self- report outcome measures (PROMIS measures, PLUS-M™, EFIB) Subtask 10: Administration of performance-based outcome 2-12 measures of prosthetic mobility (cTUG, 2-minute walk test) Milestone(s) achieved: Complete data collection for all 20 12 subjects Major task 5: Statistical analysis 9-12 Subtask 11: Provide all requested data sets on 9-12 socioenvironmental factors and mobility tests for analysis Subtask 12: Assist in interpretation of results 12 2 Subtask 13: Publication of project findings 12- Complete 2 drafts of research findings for publication Milestone(s) achieved: Completed statistical analysis and 12 interpretation of relationships between socioenvironmental factors and mobility Specific Aim 2 Timeline Deliverable Expand a national post-amputation clinical research network (months) Major task 1: Establish clinical connections for prosthetic and 0-10 post-amputation rehabilitation research in Kentucky Subtask 1: Identify potential clinical partners within the State of 0-10 Obtain verbal and/or written Kentucky and Ohio commitment from potential clinical partners including but not limited to clinics, hospitals, and amputee patient support groups. Milestone(s) achieved: Identified clinical partners for prosthetic 10 and post-amputation rehabilitation research in Kentucky and Ohio Major task 2: Establish research connections with the 0-12 participating investigators Subtask 2: Attend virtual and in-person grant development Pre- meetings award Subtask 3: Identify and contact potential local experts (clinical or 0-10 Obtain verbal and/or written academic) in prosthetics, post-amputation, and health disparity commitment of collaboration from local research experts. Subtask 4: Attend virtual research panel discussions to develop 2-12 Attend/host virtual research meetings (4 research direction including R01 scale grant applications. meetings) Subtask 5: Attend MW CTR-IN Annual Meeting (November 5 In-person attendance of the MW CTR- 2023) to meet with participating investigators IN meeting Milestone(s) achieved: Established a sustainable research 12 collaboration within the 8 participating states and beyond Target enrollment Year 1 per quarter Q1 Q2 Q3 Q4 Kentucky and Ohio sites 5555 5 10 15 20 Target Enrollment (cumulative, all sites) 3