NCT06004219

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

June 30, 2023

Last Update Submit

December 4, 2023

Conditions

Diabetic Foot UlcerDiabetic WoundDiabetes Mellitus, Type 2Diabetic FootDiabetes ComplicationsPeripheral Neuropathy

Keywords

numbnesstinglingmuscle weaknessloss of balanceshooting pain

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Acceptability Questionnaire --Peer to Pal Intervention (PPI)

    5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree

    End of study, 6 month visit

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Peer Support Group

EXPERIMENTAL

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

Behavioral: Peer counseling group

Usual Care Group

NO INTERVENTION

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

Interventions

Peer counseling groupBEHAVIORAL

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.

Peer Support Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • New ischemic DFU \<6 months
  • English or Spanish speaking
  • Able to provide consent

You may not qualify if:

  • incarceration or institutionalization
  • unwillingness to participate in the PAI program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Casa Colina Healthcare and Hospital

Pomona, California, 91767, United States

RECRUITING

Related 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.

    PMID: 28614678RESULT

  • 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.

    PMID: 26203063RESULT

  • 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.

    PMID: 34059410RESULT

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 2Diabetes ComplicationsPeripheral Nervous System DiseasesHypesthesiaParesthesiaMuscle Weakness

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeuromuscular DiseasesNervous System DiseasesSomatosensory DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsPathologic Processes

Study Officials

  • Emily Rosario, PhD

    Casa Colina Hospital and Centers for Healthcare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niko Fullmer

CONTACT

909-596-7733nfullmer@casacolina.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

June 30, 2023

First Posted

August 22, 2023

Study Start

November 21, 2023

Primary Completion

October 1, 2024

Study Completion

January 30, 2025

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)