Peer Support for Patients With Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.

Detailed Description
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Of the estimated 30 million people in the U.S. with diabetes, 34% will develop a DFU in their lifetime, and 50% of those with a DFU have concurrent PAD. Foot ulceration, which precedes 80% of amputations in diabetics, is associated with impaired physical function, reduced quality of life, and increased risk of death. Moreover, PAD, DFU, and subsequent major amputations are unevenly patterned in terms of racial/ethnic, SES, health insurance, and geographic status. More specifically, Black and Hispanic adults with an ischemic DFU have a higher prevalence of amputation than their White counterparts. The mechanisms of these observed disparities in amputation, beyond disease severity and comorbidities, are complex. However, evidence indicates that ulcer care (including wound care, diabetic shoe, offloading, and recognizing warning signs) is a significant challenge for low-income patients with an ischemic DFU. In addition, our team and other researchers have demonstrated how psychological, interpersonal, social, and healthcare system-level barriers limit appropriate ulcer and foot care. Furthermore, our qualitative data demonstrates a high rate of psychological and interpersonal factors to diabetic foot care that cannot be ignored. Clearly, there is a compelling need for innovative methods to improve DFU care that are based on health equity that led to diverse support. To address this gap, we propose a patient-centered and culturally tailored Peer-Pal Intervention (PPI) that helps promote ulcer care in patients with a DFU, while minimizing the burden placed on system resources.

Official Title
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Peer Support in Patients With Diabetic Foot Ulceration

Conditions
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Diabetic Foot Ulcer, Diabetic Wound, Diabetes Mellitus, Type 2, Diabetic Foot, Diabetes Complications, Peripheral Neuropathy

Intervention / Treatment
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* Behavioral: Peer counseling group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years New ischemic DFU <6 months English or Spanish speaking Able to provide consent Exclusion Criteria: incarceration or institutionalization unwillingness to participate in the PAI program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will assign 12 patients into peer support group (intervention) and 12 patients as control (usual care with no support group) group. Patients will be followed for 6 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Support Group<br>Patients will be asked to complete a health-related quality of life (HRQOL) survey at enrollment, 3 months, and end of the study. Participants will complete the VascuQoL-6 and PROMIS in several domains of HRQOL (including global physical function, global mental function, fatigue, depression, sleep disturbance, pain behavior, and social satisfaction). Each participant will complete the PROMIS CAT tool on an iPad App and the data will be stored in the secure REDCap | Behavioral: Peer counseling group<br>* A community advisory board (CAB) will be set up for need assessment and to design the peer support program. Virtual meetings will be held quarterly for year 1 and 2. The group will consist of (up to 12 members) and will include at least 2 patient partners (patients with a recently diagnosed ulcer), 2 peer pals (patients with a healed DFU), family members or caregivers (limited to only 1 person per family represented on the CAB), healthcare workers (podiatrist, nurse, or case manager), medical equipment company representatives, and others. We will ask them about potential barriers at the first meeting, have flexible meeting times, and intentionally limit the number of healthcare providers. At the last meeting, we will seek feedback and input from the CAB. In addition, this group will have the opportunity to participate in a focus group which will be moderated with a trained, bilingual assistant and will last 40-60 minutes.<br>|
| No Intervention: Usual Care Group<br>Subjects in this group will not participate in the peer group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VascuQoL-6 | A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a Total Quality of Life Score. A higher value indicates better health status. | Complete at enrollment visit | 
| VascuQoL-6 | A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a Total Quality of Life Score. A higher value indicates better health status. | Complete at 3 month visit | 
| VascuQoL-6 | A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a Total Quality of Life Score. A higher value indicates better health status. | Complete at 6 month visit, end of study | 
| PROMIS (Patient Reported Outcomes Measurement Information System) | Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric). | Complete at enrollment visit | 
| PROMIS (Patient Reported Outcomes Measurement Information System) | Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric). | Complete at 3 month visit | 
| PROMIS (Patient Reported Outcomes Measurement Information System) | Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric). | Complete at 6 month visit, end of study | 
| Acceptability Questionnaire --Peer to Pal Intervention (PPI) | 5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree | End of study, 6 month visit | 
| Twenty Three Item Questionnaire (Heisler) | The questionnaire is a follow-up patient assessment comprised of 23 questions derived and modified from (Heisler et al.) It is a series of open ended questions to evaluate the effectiveness and attitudes of peer support with participants who have diabetic foot ulcer. | End of Study, 6 month visit | 
| Diabetes Distress Screening Scale (DDS17) | 6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention. | Complete at enrollment visit | 
| Diabetes Distress Screening Scale (DDS17) | 6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention. | Complete at 3 month visit | 
| Diabetes Distress Screening Scale (DDS17) | 6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention. | End of study, 6 month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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numbness, tingling, muscle weakness, loss of balance, shooting pain