Peer Support for Patients With Diabetic Foot Ulcers

NCT ID: NCT06004219

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2025-01-30

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.

Conditions

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

Keywords

numbness; tingling; muscle weakness; loss of balance; shooting pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Peer Support 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

Group Type: EXPERIMENTAL

Peer counseling group

Intervention Type: BEHAVIORAL

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.

Usual Care Group

Subjects in this group will not participate in the peer group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer counseling group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: collaborator

Vascular Cures

OTHER

Sponsor Role: collaborator

Department of Health and Human Services

FED

Sponsor Role: collaborator

Rancho Los Amigos National Rehabilitation Center

OTHER

Sponsor Role: collaborator

Casa Colina Hospital and Centers for Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Emily Rosario

Executive Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Rosario, PhD

Role: PRINCIPAL_INVESTIGATOR

Casa Colina Hospital and Centers for Healthcare

Locations

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Site Status: RECRUITING

University of Southern California

Los Angeles, California, United States

Site Status: RECRUITING

Casa Colina Healthcare and Hospital

Pomona, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Niko Fullmer

Role: CONTACT

Phone: 909-596-7733

Email: nfullmer@casacolina.org

Facility Contacts

Tze-Woei Tan, MD

Role: primary

Tze-Woei Tan, MD

Role: primary

Emily Rosario, PhD

Role: primary

References

Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

Reference Type: RESULT

PMID: 28614678 (View on PubMed)

Hoffstad O, Mitra N, Walsh J, Margolis DJ. Diabetes, lower-extremity amputation, and death. Diabetes Care. 2015 Oct;38(10):1852-7. doi: 10.2337/dc15-0536. Epub 2015 Jul 22.

Reference Type: RESULT

PMID: 26203063 (View on PubMed)

Crocker RM, Palmer KNB, Marrero DG, Tan TW. Patient perspectives on the physical, psycho-social, and financial impacts of diabetic foot ulceration and amputation. J Diabetes Complications. 2021 Aug;35(8):107960. doi: 10.1016/j.jdiacomp.2021.107960. Epub 2021 May 23.

Reference Type: RESULT

PMID: 34059410 (View on PubMed)

Other Identifiers

IRB:00002372

Identifier Type: -

Identifier Source: org_study_id