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Peer Support for Patients With Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcer, Diabetic Wound, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer counseling group
Sponsored by
Casa Colina Hospital and Centers for Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Foot Ulcer focused on measuring numbness, tingling, muscle weakness, loss of balance, shooting pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rancho Los Amigos National Rehabilitation CenterRecruiting
  • University of Southern CaliforniaRecruiting
  • Casa Colina Healthcare and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer Support Group

Usual Care Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).
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).
Acceptability Questionnaire --Peer to Pal Intervention (PPI)
5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2023
Last Updated
August 15, 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
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1. Study Identification

Unique Protocol Identification Number
NCT06004219
Brief Title
Peer Support for Patients With Diabetic Foot Ulcers
Official Title
Peer Support in Patients With Diabetic Foot Ulceration
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer Support Group
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Subjects in this group will not participate in the peer group.
Intervention Type
Behavioral
Intervention Name(s)
Peer counseling group
Intervention Description
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.
Primary Outcome Measure Information:
Title
VascuQoL-6
Description
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.
Time Frame
Complete at enrollment visit
Title
VascuQoL-6
Description
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.
Time Frame
Complete at 3 month visit
Title
VascuQoL-6
Description
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.
Time Frame
Complete at 6 month visit, end of study
Title
PROMIS (Patient Reported Outcomes Measurement Information System)
Description
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).
Time Frame
Complete at enrollment visit
Title
PROMIS (Patient Reported Outcomes Measurement Information System)
Description
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).
Time Frame
Complete at 3 month visit
Title
PROMIS (Patient Reported Outcomes Measurement Information System)
Description
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).
Time Frame
Complete at 6 month visit, end of study
Title
Acceptability Questionnaire --Peer to Pal Intervention (PPI)
Description
5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree
Time Frame
End of study, 6 month visit
Title
Twenty Three Item Questionnaire (Heisler)
Description
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.
Time Frame
End of Study, 6 month visit
Title
Diabetes Distress Screening Scale (DDS17)
Description
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.
Time Frame
Complete at enrollment visit
Title
Diabetes Distress Screening Scale (DDS17)
Description
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.
Time Frame
Complete at 3 month visit
Title
Diabetes Distress Screening Scale (DDS17)
Description
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.
Time Frame
End of study, 6 month visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niko Fullmer
Phone
909-596-7733
Ext
2220
Email
nfullmer@casacolina.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Rosario, PhD
Organizational Affiliation
Casa Colina Hospital and Centers for Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tze-Woei Tan, MD
Phone
323-442-6835
Email
Tze-woei.tan@med.usc.edu
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tze-Woei Tan, MD
Phone
323-442-6835
Email
Tze-woei.tan@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Tze-Woei Tan
Facility Name
Casa Colina Healthcare and Hospital
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Rosario, PhD
Phone
909-596-7733
Ext
3036
Email
erosario@casacolina.org
First Name & Middle Initial & Last Name & Degree
Emily Rosario, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28614678
Citation
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.
Results Reference
result
PubMed Identifier
26203063
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.
Results Reference
result
PubMed Identifier
34059410
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 2021 May 23.
Results Reference
result

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Peer Support for Patients With Diabetic Foot Ulcers

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