Recruiting

Health360x

Sponsor:

Morehouse School of Medicine

Code:

NCT06217107

Conditions

Lupus Nephritis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Micro-learning content

Health360x app

Culturally congruent coaching

Study Details

Brief 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.

Conditions

Lupus Nephritis

Study ID

NCT06217107

Start date

Sep 14, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: C3 Coach plus H360x

Arm 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.

active comparator: C3 Coach plus Health360x and micro-learning

Arm 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.

Interventions

Micro-learning content

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 app

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 coaching

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.

Primary outcome measure

  • engagement [ Time Frame: Baseline, 3, 6 months ]
  • goal attainment [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Carmel Ibeawuchi, MBA

404-752-1664cIbeawuchi@msm.edu

Locations

Morehouse School of Medicine

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Carmel Ibeawuchi, MBA

404-752-1664cIbeawuchi@msm.edu

Principal Investigator:

Priscilla Pemu, MD MS, FACP

More Information

Sponsor

Morehouse School of Medicine

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Lupus
  • Lupus Nephritis
  • Health360x
  • Behavioral Intervention
  • Health coach
  • Health Literacy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Morehouse School of Medicine on 2026-07-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.