Lupus Nephritis Clinical Trial
Official title:
[2069264-1] Wellness & Workforce Solution for Lupus and Lupus Nephritis / Janssen Clinical Investigator Initiated Study
The investigators will test the hypothesis that culturally congruent coaching delivered via a technology application (Health360x) will improve the persistent disparities observed among women of color with lupus or lupus nephritis by addressing underlying psychosocial barriers to behavioral change.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. females ; Age over 18yo 4. Self-reported diagnosis of Lupus or Lupus Nephritis, or documented diagnosis of Lupus or Lupus Nephritis 5. Willingness to adhere to the study intervention regimen 6. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart-phone, internet access) 7. Not currently practicing self-management behaviors and have not participated in a class or program on self-management behavior within the last 12 months Adult women with lupus and lupus nephritis will be enrolled in the study. Eligibility: Adult women with lupus and lupus nephritis who are able to consent and participate in self-management support training. Access to the internet is required for this intervention. Ability to read English is required because all the materials are currently in English. Coaches must meet all of the following criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for duration of study 3. Women of color with lupus or lupus nephritis with desire to help others 4. Ability to communicate in English 5. Secure access to Internet 6. Private space for conducting participant visits 7. Ability to use internet-based platform Exclusion Criteria: -Potential participants and coaches who are unable to speak or read English, access the internet, or complete data collection activities will be ineligible for participation. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Morehouse School of Medicine | Janssen Scientific Affairs, LLC |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | engagement | frequency counts of app usage and patterns of usage will be combined to report application usage data | Baseline, 3, 6 months | |
Primary | goal attainment | Health360x application usage data | Baseline, 6 months | |
Secondary | change in systolic and diastolic blood pressure (mmHg) | Wireless or Universal Serial Bus enabled patient data upload | Baseline, 3, 6 months | |
Secondary | change in diet | manual entry | Baseline, 6 months | |
Secondary | change in blood glucose (mg/dL) | Wireless or Universal Serial Bus enabled patient uploads | Baseline, 3, 6 months | |
Secondary | change in total distance walked daily | Wireless or Universal Serial Bus enabled patient uploads | Baseline, 3, 6 months | |
Secondary | Health related quality of life | Health related quality of life measure in adult lupus 34 items across 8 domains (physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden to others); A mean raw score is transformed to scores ranging from 0 (worst health related quality of life) to 100 (best health related quality of life) | Baseline, 3, 6 months | |
Secondary | Fatigue | Functional assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue); 13-item patient-reported outcome instrument (PRO) that was designed to assess fatigue-related symptoms and impacts on daily functioning; Item scores can range from 0 ("not at all") to 4 ("very much"), and the total score from 0 to 52; lower scores indicate greater fatigue | Baseline, 3, 6 months | |
Secondary | Stress Management | Perceived Stress Scale-4; Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. | Baseline, 3, 6 months | |
Secondary | Pain will be measured by Brief Pain Inventory - Short Form (BPI-SF) | Brief Pain Inventory - Short Form (BPI-SF); Patients are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items or a single item can be treated as the primary outcome measure. A score relating to impact on daily life can be calculated by averaging scores on each of the seven items, which also use scales from 0 to 10. Higher scores indicate greater severity and more interference. | Baseline, 3, 6 months | |
Secondary | Depression | Short Form 36 version 2(SF-36v2); scored from 0 (worst health) to 100 (best health) | Baseline, 3 and 6 months | |
Secondary | self-efficacy | general practitioner scale (GPS) to reflect specific health activities and content of Health360x Lupus. GPS response categories use a 5-point Likert scale anchored by 1 (strongly agree) and 5 (strongly disagree) | Baseline, 3 and 6 months | |
Secondary | Depression | Patient Health Questionnaire 9; Total scores of 5, 10, 15, and 20 represent points for mild, moderate, moderately severe and severe depression, respectively. | Baseline, 3 and 6 months | |
Secondary | self-efficacy | Health self-efficacy scale; A total score, on a scale of 10 to 40, or a mean scale score, on a scale of 1 to 4, can be calculated. Higher scores indicate higher perceived general self-efficacy, lower scores indicate lower perceived general self-efficacy. | Baseline, 3 and 6 months | |
Secondary | Depression | Patient Health Questionnaire 4; Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score =3 for first 2 questions suggests anxiety. Total score =3 for last 2 questions suggests depression. | Baseline, 3 and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02936375 -
The Iguratimod Effect on Lupus Nephritis (IGeLU)
|
Phase 2 | |
Completed |
NCT03597464 -
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
|
Phase 3 | |
Recruiting |
NCT01226147 -
Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis
|
Phase 2 | |
Completed |
NCT01206569 -
Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
|
Phase 4 | |
Active, not recruiting |
NCT00569101 -
A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
|
Phase 2 | |
Terminated |
NCT00368264 -
TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )
|
Phase 2/Phase 3 | |
Completed |
NCT00371319 -
Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
|
Phase 4 | |
Completed |
NCT00298506 -
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)
|
N/A | |
Completed |
NCT00094380 -
Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)
|
Phase 1/Phase 2 | |
Terminated |
NCT04376827 -
A Study of Guselkumab in Participants With Active Lupus Nephritis
|
Phase 2 | |
Completed |
NCT03610516 -
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.
|
Phase 2 | |
Recruiting |
NCT03526042 -
Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis
|
N/A | |
Withdrawn |
NCT03859570 -
Pentoxifylline in Lupus Nephritis
|
Phase 4 | |
Completed |
NCT03664908 -
Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)?
|
N/A | |
Completed |
NCT01085097 -
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
|
Phase 2 | |
Active, not recruiting |
NCT05704088 -
SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients
|
Phase 4 | |
Not yet recruiting |
NCT06429800 -
A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis
|
Phase 1 | |
Recruiting |
NCT02226341 -
ACTHar in the Treatment of Lupus Nephritis
|
Phase 4 | |
Recruiting |
NCT02453997 -
Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis
|
N/A | |
Completed |
NCT01470183 -
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
|
N/A |