Peer Support for Patients With Diabetic Foot Ulcers
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ClinicalTrials.gov Identifier: NCT06004219 |
Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : December 6, 2023
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Condition or disease | Intervention/treatment | Phase |
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Diabetic Foot Ulcer Diabetic Wound Diabetes Mellitus, Type 2 Diabetic Foot Diabetes Complications Peripheral Neuropathy | Behavioral: Peer counseling group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
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 |
Official Title: | Peer Support in Patients With Diabetic Foot Ulceration |
Actual Study Start Date : | November 21, 2023 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | January 30, 2025 |
Arm | Intervention/treatment |
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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
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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. |
No Intervention: Usual Care Group
Subjects in this group will not participate in the peer group.
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- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06004219
Contact: Niko Fullmer | 909-596-7733 ext 2220 | nfullmer@casacolina.org |
United States, California | |
Rancho Los Amigos National Rehabilitation Center | Recruiting |
Downey, California, United States, 90242 | |
Contact: Tze-Woei Tan, MD 323-442-6835 Tze-woei.tan@med.usc.edu | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Tze-Woei Tan, MD 323-442-6835 Tze-woei.tan@med.usc.edu | |
Principal Investigator: Tze-Woei Tan | |
Casa Colina Healthcare and Hospital | Recruiting |
Pomona, California, United States, 91767 | |
Contact: Emily Rosario, PhD 909-596-7733 ext 3036 erosario@casacolina.org | |
Principal Investigator: Emily Rosario, PhD |
Principal Investigator: | Emily Rosario, PhD | Casa Colina Hospital and Centers for Healthcare |
Responsible Party: | Emily Rosario, Executive Director, Casa Colina Hospital and Centers for Healthcare |
ClinicalTrials.gov Identifier: | NCT06004219 |
Other Study ID Numbers: |
IRB:00002372 |
First Posted: | August 22, 2023 Key Record Dates |
Last Update Posted: | December 6, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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Peripheral Nervous System Diseases Diabetic Foot Foot Ulcer Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Complications Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases Foot Diseases |