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| ID | Type | Description | Link |
|---|---|---|---|
| 3P30AR072582-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| University of Alabama at Birmingham | OTHER |
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To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigator Services | Behavioral | The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Quality of Life | Qualify of life measured by the "LupusPRO" patient-reported questionnaire administered at Baseline and 12 Months in the Intervention Group, resulting in a LupusPRO score. LupusPRO (v1.8) includes 43 items with domains of Lupus Symptoms, Lupus Medication, Physical Health, Emotional Health, Pain, Sleep, Procreation, Cognition, Body Image, Desires-Goals, Coping, Social Support and Satisfaction with Care rated on a 5 point Likert scale, where 0=None of the time/not applicable, 1= A little of the time, 2= Some of the time, 3=Most of the time, 4= All of the time, 5= Not applicable. Total scores measure health (HRQOL) and non-health related quality of life (Non HRQOL). Item scores are totaled for each domain item and the mean domain score is obtained by dividing the total score by the number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 (the number of Likert responses {5 responses | 12 months - from baseline to 12 month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Medication Adherence | Adherence with prescribed medical therapies will be defined as the ratio between the number of therapy-days supplied to the number of days until the prescription was refilled and compared between Lupus Patient Navigator Program (LPNP) participants and usual care patients. Medication adherence rates will be estimated by charts review and comparing these medications to pharmacy records on dates and quantities filled. Included medication classifications will include antihypertensives, immunosuppressants, Plaquenil (hydroxychloroquine), and glucocorticoids. Additionally, overall pill burden will be compared between LPNP participants and usual care patients. LPNP participants' medication diaries will be reviewed to determine self-reported adherence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim C. Oates, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Group | Patient Navigator Services: The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support |
| FG001 | Usual Care Comparison Group | Usual Care Comparison Group meeting eligibility criteria for intervention but not receiving Lupus Patient Navigator Program services. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with SLE
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Receiving Lupus Patient Navigator Program services. |
| BG001 | Usual Care Comparison Group | Usual Care Comparison Group meeting eligibility criteria for intervention but not receiving Lupus Patient Navigator Program services. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement in Quality of Life | Qualify of life measured by the "LupusPRO" patient-reported questionnaire administered at Baseline and 12 Months in the Intervention Group, resulting in a LupusPRO score. LupusPRO (v1.8) includes 43 items with domains of Lupus Symptoms, Lupus Medication, Physical Health, Emotional Health, Pain, Sleep, Procreation, Cognition, Body Image, Desires-Goals, Coping, Social Support and Satisfaction with Care rated on a 5 point Likert scale, where 0=None of the time/not applicable, 1= A little of the time, 2= Some of the time, 3=Most of the time, 4= All of the time, 5= Not applicable. Total scores measure health (HRQOL) and non-health related quality of life (Non HRQOL). Item scores are totaled for each domain item and the mean domain score is obtained by dividing the total score by the number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 (the number of Likert responses {5 responses | 52 patients with SLE self identified as a minority, met inclusion / exclusion criteria, and provided informed consent to participate with the Lupus Patient Navigator Program intervention. | Posted | Mean | Standard Deviation | score on a scale | 12 months - from baseline to 12 month visit |
1 year
Only deaths were assessed. Serious and non-serious/other adverse events were not assessed. Patients are already routinely monitored by their clinicians for standard of care.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Group | Patient Navigator Services: The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jim C. Oates, MD, Rheumatology Division Director | Medical University of South Carolina | 843-792-1991 | oatesjc@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2021 | Mar 22, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2020 | Jun 21, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 12 months - from baseline to 12 month visit |
| Improvement in Patient-reported Lupus-specific Disease Status | Changes in patient-reported lupus-specific disease status (measured by the LupusPRO v1.7) over time, from Baseline, 3, 6, 9, and 12 months, compared between interventional and usual care groups will be completed at the start and end of participation. The LupusPRO is a validated, comprehensive patient reported quality of life questionnaire specific for patients with lupus. Domain areas include: lupus symptoms, cognition, physical health, pain vitality, procreation, emotional health, body image, desires-goals, social support, coping, and satisfaction with care. | 12 months - from baseline to 12 month visit |
| Improvement in Adherence With Medical Providers and Services | Adherence with medical providers and services will be the ratio of number of visits scheduled to the number of visits kept. Rates will be compared between LPNP participants and usual care patients. | 12 months - from baseline to 12 month visit |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age at lupus onset | Mean | Standard Deviation | years |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Interventional Group | Patient Navigator Services: The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support |
|
|
| Secondary | Improvement in Medication Adherence | Adherence with prescribed medical therapies will be defined as the ratio between the number of therapy-days supplied to the number of days until the prescription was refilled and compared between Lupus Patient Navigator Program (LPNP) participants and usual care patients. Medication adherence rates will be estimated by charts review and comparing these medications to pharmacy records on dates and quantities filled. Included medication classifications will include antihypertensives, immunosuppressants, Plaquenil (hydroxychloroquine), and glucocorticoids. Additionally, overall pill burden will be compared between LPNP participants and usual care patients. LPNP participants' medication diaries will be reviewed to determine self-reported adherence. | Not Posted | Aug 2026 | 12 months - from baseline to 12 month visit | Participants |
| Secondary | Improvement in Patient-reported Lupus-specific Disease Status | Changes in patient-reported lupus-specific disease status (measured by the LupusPRO v1.7) over time, from Baseline, 3, 6, 9, and 12 months, compared between interventional and usual care groups will be completed at the start and end of participation. The LupusPRO is a validated, comprehensive patient reported quality of life questionnaire specific for patients with lupus. Domain areas include: lupus symptoms, cognition, physical health, pain vitality, procreation, emotional health, body image, desires-goals, social support, coping, and satisfaction with care. | Not Posted | Aug 2026 | 12 months - from baseline to 12 month visit | Participants |
| Secondary | Improvement in Adherence With Medical Providers and Services | Adherence with medical providers and services will be the ratio of number of visits scheduled to the number of visits kept. Rates will be compared between LPNP participants and usual care patients. | Not Posted | Aug 2026 | 12 months - from baseline to 12 month visit | Participants |
| 0 |
| 52 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care Comparison Group | Usual Care Comparison Group meeting eligibility criteria for intervention but not receiving Lupus Patient Navigator Program services. | 0 | 23 | 0 | 0 | 0 | 0 |
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