Peer Support for Patients With Diabetic Foot Ulcers

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Diabetes Complications; Diabetic Foot Ulcer; Diabetic Wound; Peripheral Neuropathy; Diabetic Foot
• Interventions: Behavioral: Peer counseling group

• Registration Number: NCT06004219
• Lead Sponsor: Casa Colina Hospital and Centers for Healthcare

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-22
• Study Start: 2023-11-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-10
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Support Group	Peer counseling group	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

Primary Outcome Measures

Name	Time	Method
PROMIS (Patient Reported Outcomes Measurement Information System)	Complete at 6 month visit, end of study	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).
Acceptability Questionnaire --Peer to Pal Intervention (PPI)	End of study, 6 month visit	5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree
Twenty Three Item Questionnaire (Heisler)	End of Study, 6 month visit	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.
VascuQoL-6	Complete at 6 month visit, end of study	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.
Diabetes Distress Screening Scale (DDS17)	End of study, 6 month visit	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.

Trial Locations

Locations (3)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Casa Colina Healthcare and Hospital; 🇺🇸 Pomona, California, United States