Wellness & Workforce Solution for Lupus/Lupus Nephritis

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Morehouse School of Medicine
Study ID
NCT06217107
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Micro-learning content — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Jan 22, 2024
Start date
Sep 14, 2024
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

engagement [ Time Frame: Baseline, 3, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Morehouse School of MedicineAtlantaGeorgia30310
Carmel Ibeawuchi, MBA
[email protected]
404-752-1664
Priscilla Pemu, MD MS, FACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

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By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Morehouse School of Medicine· Atlanta, GA

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