Peer Support for Patients With Diabetic Foot Ulcers

• ClinicalTrials.gov Identifier: NCT06004219
• Recruitment Status: Recruiting
• First Posted: August 22, 2023
• Last Update Posted: December 6, 2023
• Sponsor: Casa Colina Hospital and Centers for Healthcare
• Collaborators: University of Southern California; Vascular Cures; Department of Health and Human Services; Rancho Los Amigos National Rehabilitation Center
• Information provided by (Responsible Party): Emily Rosario, Casa Colina Hospital and Centers for Healthcare

Tracking Information

• First Submitted Date: June 30, 2023
• First Posted Date: August 22, 2023
• Last Update Posted Date: December 6, 2023
• Actual Study Start Date: November 21, 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2023)

• VascuQoL-6 [ Time Frame: Complete at enrollment visit ]
  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.
• VascuQoL-6 [ Time Frame: Complete at 3 month visit ]
  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.
• VascuQoL-6 [ Time Frame: 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.
• PROMIS (Patient Reported Outcomes Measurement Information System) [ Time Frame: Complete at enrollment visit ]
  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).
• PROMIS (Patient Reported Outcomes Measurement Information System) [ Time Frame: Complete at 3 month visit ]
  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).
• PROMIS (Patient Reported Outcomes Measurement Information System) [ Time Frame: 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) [ Time Frame: End of study, 6 month visit ]
  5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree
• Twenty Three Item Questionnaire (Heisler) [ Time Frame: 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.
• Diabetes Distress Screening Scale (DDS17) [ Time Frame: Complete at enrollment 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.
• Diabetes Distress Screening Scale (DDS17) [ Time Frame: Complete at 3 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.
• Diabetes Distress Screening Scale (DDS17) [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Peer Support for Patients With Diabetic Foot Ulcers
• Official Title: Peer Support in Patients With Diabetic Foot Ulceration
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care

Condition

• Diabetic Foot Ulcer
• Diabetic Wound
• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetes Complications
• 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.

Study Arms

• Experimental: 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
  Intervention: Behavioral: Peer counseling group
• No Intervention: Usual Care Group
  Subjects in this group will not participate in the peer group.

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 15, 2023): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 30, 2025
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Niko Fullmer; 909-596-7733 ext 2220; nfullmer@casacolina.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06004219
• Other Study ID Numbers: IRB:00002372
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Emily Rosario, Casa Colina Hospital and Centers for Healthcare
• Original Responsible Party: Same as current
• Current Study Sponsor: Casa Colina Hospital and Centers for Healthcare
• Original Study Sponsor: Same as current

Collaborators

• University of Southern California
• Vascular Cures
• Department of Health and Human Services
• Rancho Los Amigos National Rehabilitation Center

Investigators

• Principal Investigator: Emily Rosario, PhD; Casa Colina Hospital and Centers for Healthcare

• PRS Account: Casa Colina Hospital and Centers for Healthcare
• Verification Date: December 2023