Peer Support for Patients With Diabetic Foot Ulcers

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Peer Support in Patients With Diabetic Foot Ulceration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004219
• Other study ID #: IRB:00002372
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: December 2023
• Source: Casa Colina Hospital and Centers for Healthcare
• Contact: Niko Fullmer
• Phone: 909-596-7733
• Email: nfullmer[@]casacolina.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 30, 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetic Foot Ulcer
• Diabetic Wound
• Foot Ulcer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	University of Southern California	Los Angeles	California
United States	Casa Colina Healthcare and Hospital	Pomona	California

Sponsors (5)

Lead Sponsor	Collaborator
Casa Colina Hospital and Centers for Healthcare	Department of Health and Human Services, Rancho Los Amigos National Rehabilitation Center, University of Southern California, Vascular Cures

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Acceptability Questionnaire --Peer to Pal Intervention (PPI)	5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree	End of study, 6 month visit
Primary	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
Primary	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
Primary	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
Primary	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