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Lupus NephritisNCT06217107

Wellness & Workforce Solution for Lupus/Lupus Nephritis

A study testing Micro-learning content, Health360x app and Culturally congruent coaching in people with Lupus Nephritis, run by Morehouse School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Lupus Nephritis
What is being tested?
Micro-learning content, Health360x app and Culturally congruent coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
14 Sep 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • females ; Age over 18yo
  • Self-reported diagnosis of Lupus or Lupus Nephritis, or documented diagnosis of Lupus or Lupus Nephritis
  • Willingness to adhere to the study intervention regimen
  • Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart-phone, internet access)
Show all 16Show fewer
  • 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:
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for duration of study
  • Women of color with lupus or lupus nephritis with desire to help others
  • Ability to communicate in English
  • Secure access to Internet
  • Private space for conducting participant visits
  • Ability to use internet-based platform

Who cannot join

  • -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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carmel Ibeawuchi, MBA contact

404-752-1664

cIbeawuchi@msm.edu

United States1 site, 1 recruiting

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

    Carmel Ibeawuchi, MBA, 404-752-1664, cIbeawuchi@msm.edu

    Priscilla Pemu, MD MS, FACP

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

The investigators' proposed intervention combines technology with culturally congruent coaching (C3) to increase access and engagement of women of color with lupus through remote instruction. 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. The investigators will attain this by connecting patients to extensively trained coaches who have lived experiences that clinicians and providers often lack. These shared social and cultural experiences breeds trust and allows for more open communication that the coach can use to provide more appropriate guidance. Leveraging technology, the investigators' program is asynchronous, promotes engagement and retention of information through micro-learning, and allows the investigators to better understand patient experiences beyond structured surveys by capturing what is happening in the patient-coach relationship.

Conditions
Lupus Nephritis
Being tested
Micro-learning content, Health360x app, Culturally congruent coaching
Keywords
Lupus, Lupus Nephritis, Health360x, Behavioral Intervention, Health coach, Health Literacy
Medical subject headings
Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Micro-learning contentBehavioural

    This is a series of modules designed to provide disease education, additional communication through 'push notifications,' promote self-management, and medication adherence in women of color with lupus and lupus nephritis. Leveraging technology, this program is asynchronous, promotes engagement and retention of information through micro-learning, and allows the investigators to better understand patient experiences beyond structured surveys by capturing what is happening in the patient-coach relationship.

  • Health360x appBehavioural

    The coach and participant will use problem-solving tools embedded in Health360x to map out potential barriers to goal attainment and create goal action plans. This application has the potential to help improve health-related quality of life, and reduce morbidity and mortality associated with Lupus. The intervention also tests the role of health coaches in the lupus ecosystem. The potential economic gain and impact on more extant social determinants of health can create long ranging benefits on the health and wellbeing of the community.

  • Culturally congruent coachingBehavioural

    The coaching process includes specified visits over the course of our proposed 6-month intervention. These visits will occur remotely using HIPAA compliant video conferencing tools or in person when it is safe and convenient to meet in person. Overall, the coaches will work with Lupus patients to facilitate experiential learning, improve functioning and performance in the context of working towards specific goals.

Study groups in NCT06217107
Study groupRoleWhat they receive
C3 Coach plus H360xExperimentalArm 1 will have 80 participants who will receive four weekly goal setting sessions with coach consisting of 45 min-1 hour recorded sessions. They will then receive another 4 sessions every 2 weeks, followed by three monthly goal setting sessions. Baseline surveys will be collected, in addition to surveys taken at 3 and 6 months.
Receives: Behavioral: Health360x app; Behavioral: Culturally congruent coaching
C3 Coach plus Health360x and micro-learningActive comparatorArm 2 will have 80 participants who will receive four weekly goal setting sessions with coach consisting of 45 min-1 hour recorded sessions, in addition to periodic micro-learning content delivered via an online technology platform. They will then receive another 4 sessions every 2 weeks, followed by three monthly goal setting sessions. Baseline surveys will be collected, in addition to surveys taken at 3 and 6 months. This arm will have learning augmented by micro-learning to test effectiveness in enhancing engagement and promoting retention of educational content.
Receives: Behavioral: Micro-learning content; Behavioral: Health360x app; Behavioral: Culturally congruent coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. engagement

    frequency counts of app usage and patterns of usage will be combined to report application usage data

    Measured: Baseline, 3, 6 months

  2. goal attainment

    Health360x application usage data

    Measured: Baseline, 6 months

Secondary outcomes (13)

  1. change in systolic and diastolic blood pressure (mmHg)

    Wireless or Universal Serial Bus enabled patient data upload

    Measured: Baseline, 3, 6 months

  2. change in diet

    manual entry

    Measured: Baseline, 6 months

  3. change in blood glucose (mg/dL)

    Wireless or Universal Serial Bus enabled patient uploads

    Measured: Baseline, 3, 6 months

  4. change in total distance walked daily

    Wireless or Universal Serial Bus enabled patient uploads

    Measured: Baseline, 3, 6 months

  5. 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)

    Measured: Baseline, 3, 6 months

  6. 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

    Measured: Baseline, 3, 6 months

  7. 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.

    Measured: Baseline, 3, 6 months

  8. 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.

    Measured: Baseline, 3, 6 months

  9. Depression

    Short Form 36 version 2(SF-36v2); scored from 0 (worst health) to 100 (best health)

    Measured: Baseline, 3 and 6 months

  10. 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)

    Measured: Baseline, 3 and 6 months

  11. Depression

    Patient Health Questionnaire 9; Total scores of 5, 10, 15, and 20 represent points for mild, moderate, moderately severe and severe depression, respectively.

    Measured: Baseline, 3 and 6 months

  12. 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.

    Measured: Baseline, 3 and 6 months

  13. 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.

    Measured: Baseline, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start14 Sep 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06217107
Sponsor's protocol ID
NOPRODSLE4002
Status last verified
Jul 2026
First submitted
8 Dec 2023
Last updated
24 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Micro-learning content, Health360x app and Culturally congruent coaching in people with Lupus Nephritis, run by Morehouse School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carmel Ibeawuchi, MBA (404-752-1664, cIbeawuchi@msm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

engagement (time frame: Baseline, 3, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06217107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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